206. 脆弱X症候群 Fragile X syndrome Clinical trials / Disease details


臨床試験数 : 104 薬物数 : 87 - (DrugBank : 32) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 79

  
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
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PhaseCountries
1NCT04823052
(ClinicalTrials.gov)
January 202224/3/2021Investigation of Sulindac in Male Fragile X Syndrome Patients Aged 13-40A Phase IIa, Double-blind, Placebo-controlled Adaptive Design Study to Explore the Safety and Efficacy of Sulindac (HX02_01) Alone and Subsequently in Combination With Other Drugs in Adolescent and Adult Males With Fragile X Syndrome (FXS)Fragile X SyndromeDrug: Sulindac, dose strength 1;Drug: Sulindac, dose strength 2;Drug: PlaceboHealx LimitedNULLNot yet recruiting13 Years40 YearsMale36Phase 2United States
2NCT05120505
(ClinicalTrials.gov)
December 29, 20213/11/2021Metformin in Children With Fragile X SyndromeEfficacy and Safety of Metformin in the Treatment of Fragile X SyndromeFragile X Syndrome;MetforminDrug: Metformin;Drug: PlaceboChildren's Hospital of Fudan UniversityNULLRecruiting2 Years16 YearsAll20Phase 4China
3NCT05163808
(ClinicalTrials.gov)
December 15, 202115/12/2021A Randomized Study of BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, Two-Part Study of High and Low Dose BPN14770 in Male Adolescents (Aged 12 to < 18 Years) With Fragile X SyndromeFragile X SyndromeDrug: zatolmilast;Drug: PlaceboTetra Discovery PartnersNULLNot yet recruiting12 Years18 YearsMale150Phase 2/Phase 3NULL
4NCT05030129
(ClinicalTrials.gov)
September 15, 20215/8/2021Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X SyndromeAn Exploratory Single Blind Study of Ergoloid Mesylates, 5-Hydroxytryptophan, and the Combination in Adult Males With Fragile X SyndromeFragile X SyndromeDietary Supplement: 5-Hydroxytryptophan / Vitamin B6;Drug: Ergoloid Mesylate;Other: PlaceboElizabeth Berry-KravisNULLNot yet recruiting18 Years45 YearsMale15Phase 2NULL
5NCT04977986
(ClinicalTrials.gov)
September 13, 202120/7/2021Clinical Study of Cannabidiol in Children and Adolescents With Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - RECONNECTFragile X SyndromeDrug: ZYN002 - transdermal gel;Drug: PlaceboZynerba Pharmaceuticals, Inc.NULLRecruiting3 Years17 YearsAll204Phase 3United States;Australia;Ireland;United Kingdom
6NCT04314856
(ClinicalTrials.gov)
January 12, 202111/3/2020Novel Clinical Target in Fragile X SyndromeSigma-1 Receptors: A Novel Clinical Target in Fragile X SyndromeFragile X Syndrome (FXS)Drug: 18F-FTC-146Guido A. Davidzon, MD, MSNULLRecruiting18 Years65 YearsAll20Phase 1United States
7NCT04141163
(ClinicalTrials.gov)
October 29, 201924/10/2019Metformin in Patients With Fragile XA Parallel Group Design Randomized Double-Blind Trial of Metformin Treatment in Patients With Fragile X Syndrome on Safety and Effects on Cognition, Anxiety, Attention and BiomarkersFragile X SyndromeDrug: Metformin;Drug: Placebo oral tabletRowan UniversityFRAXA Research Foundation;University of PennsylvaniaRecruiting18 Years50 YearsMale40Phase 1/Phase 2United States
8NCT03862950
(ClinicalTrials.gov)
May 24, 201926/2/2019A Trial of Metformin in Individuals With Fragile X Syndrome (Met)A Double-Blind, Placebo-Controlled Trial of Metformin in Individuals With Fragile X Syndrome (FXS)Fragile X Syndrome;Fragile X Mental Retardation Syndrome;Mental Retardation, X-Linked;Genetic Diseases, X-Linked;Trinucleotide Repeat Expansion;Fra(X) Syndrome;Intellectual Disability;FXS;Neurobehavioral Manifestations;Sex Chromosome DisordersDrug: Placebo Medication;Drug: MetforminUniversity of AlbertaSt. Justine's HospitalRecruiting6 Years35 YearsAll120Phase 2Canada
9NCT03802799
(ClinicalTrials.gov)
November 9, 201826/12/2018Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXSAn Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome - CONNECT-FX Open Label Extension (OLE)Fragile X SyndromeDrug: ZYN002 - CBD Transdermal GelZynerba Pharmaceuticals, Inc.NULLEnrolling by invitation3 Years18 YearsAll300Phase 2/Phase 3United States;Australia;New Zealand
10NCT03697161
(ClinicalTrials.gov)
September 17, 20181/10/2018A Study of OV101 in Individuals With Fragile X SyndromeA Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X SyndromeFragile X Syndrome (FXS)Drug: OV101 (gaboxadol)Ovid Therapeutics Inc.NULLCompleted13 Years22 YearsMale23Phase 2United States
11NCT03722290
(ClinicalTrials.gov)
September 1, 201824/10/2018Metformin in Children and Adults With Fragile X SyndromeEvaluate the Efficacy and Safety of Metformin in Children and Adults With Fragile X Syndrome: an Open-label StudyFragile X SyndromeDrug: MetforminUniversité de SherbrookeFRAXA Research FoundationCompleted10 Years45 YearsAll15Phase 2Canada
12NCT03569631
(ClinicalTrials.gov)
July 9, 201825/5/2018A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, 2-period Crossover Study of BPN14770 in Adult Males With Fragile X SyndromeFragile X Syndrome;FXS;Fra(X) SyndromeDrug: BPN14770;Drug: PlaceboTetra Discovery PartnersNULLCompleted18 Years45 YearsMale30Phase 2United States
13NCT03614663
(ClinicalTrials.gov)
June 12, 201810/7/2018Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X SyndromeFragile X SyndromeDrug: ZYN002 - CBD Transdermal Gel;Other: Placebo Transdermal GelZynerba Pharmaceuticals, Inc.NULLCompleted3 Years17 YearsAll212Phase 2/Phase 3United States;Australia;New Zealand
14NCT03479476
(ClinicalTrials.gov)
April 30, 201820/3/2018A Trial of Metformin in Individuals With Fragile X SyndromeA Double-Blind, Placebo-Controlled Trial of Metformin in Individuals With Fragile X SyndromeFragile X Syndrome;Fragile X Mental Retardation Syndrome;Mental Retardation, X Linked;Genetic Diseases, X-Linked;Trinucleotide Repeat Expansion;Fra(X) Syndrome;Intellectual Disability;FXS;Neurobehavioral Manifestations;Sex Chromosome DisordersDrug: Placebo Medication;Drug: MetforminUniversity of California, DavisNULLRecruiting6 Years25 YearsAll60Phase 2/Phase 3United States
15NCT03624556
(ClinicalTrials.gov)
January 29, 20186/6/2018Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)Down Syndrome;Fragile X SyndromeDietary Supplement: EGCG FontUp;Other: Placebo FontUpParc de Salut MarHospital Infantil Universitario Niño Jesús, Madrid, Spain;Instituto Hispalense de Pediatría, Sevilla, Spain;Hospital Universitario Marqués de Valdecilla;Institut Jerome LejeuneCompleted6 Years12 YearsAll76N/ASpain
16NCT03140813
(ClinicalTrials.gov)
January 16, 201817/4/2017An Initial Study of AZD7325 in Adults With Fragile X SyndromeAn Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X SyndromeFragile X SyndromeDrug: AZD7325 (High-Dose);Drug: AZD7325 (Low-Dose);Drug: Placebo oral capsuleChildren's Hospital Medical Center, CincinnatiNULLCompleted18 Years50 YearsAll15Phase 1United States
17NCT02920892
(ClinicalTrials.gov)
August 17, 201728/9/2016AFQ056 for Language Learning in Children With FXSEffects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS)Fragile X SyndromeDrug: AFQ056;Other: Placebo;Other: Language InterventionElizabeth Berry-KravisNational Institute of Neurological Disorders and Stroke (NINDS)Active, not recruiting32 Months6 YearsAll99Phase 2United States
18NCT03109756
(ClinicalTrials.gov)
April 3, 20176/4/2017Single Dose Pharmacokinetic (PK) StudyA Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman SyndromeAngelman Syndrome;Fragile X SyndromeDrug: OV101Ovid Therapeutics Inc.NULLCompleted13 Years17 YearsAll12Phase 1United States
19NCT04308954
(ClinicalTrials.gov)
November 1, 201611/3/2020Neuroimaging GABA Physiology in Fragile X SyndromeCross-Species Multi-Modal Neuroimaging to Investigate GABA Physiology in Fragile X SyndromeFragile X Syndrome (FXS);Idiopathic Intellectual Developmental Disorder (IDD)Drug: [18F]flumazenilStanford UniversityNULLTerminated18 Years30 YearsMale17Phase 1United States
20EUCTR2015-005460-42-ES
(EUCTR)
07/07/201620/04/2016Clinical trial to evaluate ascorbic acid (vitamin C) and tocopherol (vitamin E) in combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndromePhase III clinical trial, double-blind, cross-way, to evaluate the safety and efficacy ascorbic acid (vitamin C) and tocopherol (vitamin E) combination versus placebo for the treatment of cognitive and behavioral disorders in children with fragile x syndrome Fragile x syndrome
MedDRA version: 19.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Vitamin C
INN or Proposed INN: Vitamin C
Other descriptive name: ACIDUM ASCORBICUM D6
Product Name: Vitamin E
INN or Proposed INN: Vitamin E
Other descriptive name: TOCOPHERYL ACETATE
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludNULLNot RecruitingFemale: no
Male: yes
Phase 3Spain
21NCT02942498
(ClinicalTrials.gov)
July 20167/10/2016Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X SyndromeClinical Trials Phase III, Double Blind, Crossover to Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X SyndromeX Fragile SyndromeDrug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg;Drug: PlaceboFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludDelos ClinicalRecruiting1 Year8 YearsBoth40Phase 3Spain
22NCT02719951
(ClinicalTrials.gov)
April 20169/3/2016Glutaminergic Transmission in Autism : Molecular Imaging ExplorationGlutaminergic Transmission in Autism : Molecular Imaging ExplorationAutism;Fragile-X Syndrome (FXS);Healthy VolunteersDrug: [18F]FPEB PET imaging;Other: Biological samples;Other: MRIUniversity Hospital, ToursNULLCompleted18 Years45 YearsMale27Phase 1France
23NCT02680379
(ClinicalTrials.gov)
March 201625/1/2016Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X SyndromeA Pilot Study Exploring the Safety and Synergistic Effect of a Minocycline/Lovastatin Combined Treatment on the Behavior of Individuals With Fragile X Syndrome; Validation of New Biochemical and Neurophysiological Markers (LovaMiX)Fragile X SyndromeDrug: Minocycline, then Minocycline/Lovastatin;Drug: Lovastatin, then Minocycline/LovastatinUniversité de SherbrookeFRAXA Research FoundationCompleted8 Years45 YearsAll22Phase 2Canada
24NCT02998151
(ClinicalTrials.gov)
January 20161/12/2016Neurophysiological and Acute Pharmacological Studies in FXS PatientsNeurophysiological and Acute Pharmacological Studies in FXS PatientsFragile X SyndromeDrug: Acamprosate;Drug: Lovastatin;Drug: Minocycline;Drug: Placebo;Drug: BaclofenChildren's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed15 Years55 YearsAll29Early Phase 1United States
25NCT02642653
(ClinicalTrials.gov)
January 201621/12/2015Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X SyndromeCombining Lovastatin and a Parent-Implemented Language Intervention in a Multimodal Treatment for Fragile X SyndromeFragile X Syndrome;Genetic DiseasesDrug: Lovastatin;Other: PlaceboUniversity of California, DavisNULLCompleted10 Years17 YearsAll30Phase 4United States
26EUCTR2014-000251-89-BE
(EUCTR)
22/10/201418/08/2014A clinical study with an investigational drug called ganaxolone in children with fragile X syndromeA controlled double-blind crossover trial of ganaxolone in children with fragile X syndrome - GNX study behavioral problems in children with fragile X syndrome
MedDRA version: 17.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ganaxolone
Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316
INN or Proposed INN: GANAXOLONE
Antwerp University HospitalNULLNot RecruitingFemale: yes
Male: yes
60United States;Belgium
27NCT02126995
(ClinicalTrials.gov)
June 201429/4/2014A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X SyndromeA 6-week, Randomized, Multicenter, Double-blind, Parallel, Flexed and Fixed-dose Study of MG01CI (Metadoxine Extended-release) Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X SyndromeFragile X SyndromeDrug: MG01CI extended-release tabletAlcobra Ltd.NULLCompleted15 Years55 YearsBoth62Phase 2United States;Israel
28NCT01894958
(ClinicalTrials.gov)
January 20143/7/2013A Safety Study of NNZ-2566 in Patients With Fragile X SyndromeA Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of NNZ-2566 in Fragile X SyndromeFragile X SyndromeDrug: NNZ-2566;Drug: PlaceboNeuren Pharmaceuticals LimitedNULLCompleted12 Years45 YearsMale72Phase 2United States
29EUCTR2011-002379-40-BE
(EUCTR)
02/12/201324/10/2013Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Indonesia;Turkey;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Sweden
30NCT01911455
(ClinicalTrials.gov)
August 27, 201326/7/2013Study of Acamprosate in Fragile x SyndromeDouble-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X SyndromeFragile X SyndromeDrug: acamprosate;Drug: PlaceboChildren's Hospital Medical Center, CincinnatiRush University Medical CenterCompleted5 Years23 YearsAll46Phase 1United States
31EUCTR2011-002379-40-NL
(EUCTR)
08/07/201308/05/2013Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
32EUCTR2010-022638-96-NL
(EUCTR)
08/07/201308/05/2013Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 16.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
33NCT01855971
(ClinicalTrials.gov)
June 11, 20139/5/2013Using Epigallocatechin Gallate (EGCG) and Cognitive Training to Modulate Cognitive Performance in Patients With Fragile X Syndrome (TESFX)Estrogen Receptors Beta (ER-B) as Therapeutic Targets for the Improvement of Cognitive Performance in Fragile-X (TESXF)Fragile X SyndromeDietary Supplement: EGCG;Dietary Supplement: Placebo;Other: Cognitive trainingParc de Salut MarNULLCompleted18 Years60 YearsAll44Phase 2Spain
34EUCTR2010-022638-96-BE
(EUCTR)
27/05/201318/04/2013Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: Mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Sweden
35NCT01750957
(ClinicalTrials.gov)
February 201311/12/2012A Study of RO4917523 in Pediatric Patients With Fragile X SyndromeA Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X SyndromeFragile X SyndromeDrug: Placebo;Drug: RO4917523Hoffmann-La RocheNULLCompleted5 Years13 YearsBoth47Phase 2United States
36NCT01725152
(ClinicalTrials.gov)
November 20127/11/2012Ganaxolone Treatment in Children With Fragile X SyndromeA Controlled, Double-blind, Crossover Trial of Ganaxolone in Children With Fragile X SyndromeFragile x SyndromeDrug: Ganaxolone;Drug: PlaceboMarinus PharmaceuticalsUniversity of California, Davis;U.S. Army Medical Research and Development CommandCompleted6 Years17 YearsAll59Phase 2United States;Belgium
37EUCTR2011-004349-42-ES
(EUCTR)
16/08/201221/05/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. Fragile X Syndrome (FXS)
MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F18
Other descriptive name: mGlu5 antagonist
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F19
Other descriptive name: mGlu5 antagonist
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
38EUCTR2011-004349-42-GB
(EUCTR)
16/07/201225/04/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. Fragile X Syndrome (FXS)
MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F18
Other descriptive name: mGlu5 antagonist
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F19
Other descriptive name: mGlu5 antagonist
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;France;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
39EUCTR2011-004349-42-SE
(EUCTR)
29/06/201202/05/2012A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeA randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome. Fragile X Syndrome (FXS)
MedDRA version: 14.1;Level: LLT;Classification code 10025463;Term: Major depressive disorder, single episode;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F18
Other descriptive name: mGlu5 antagonist
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F19
Other descriptive name: mGlu5 antagonist
F. Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
180France;United States;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
40EUCTR2011-002379-40-FR
(EUCTR)
27/06/201224/08/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 15.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
41EUCTR2011-002379-40-ES
(EUCTR)
25/05/201222/02/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open?label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden
42EUCTR2011-004867-65-ES
(EUCTR)
25/05/201229/03/2012Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X SyndromeSequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2) Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Spain;United States
43NCT01517698
(ClinicalTrials.gov)
May 201220/1/2012A Study of RO4917523 in Patients With Fragile X SyndromeA Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.Fragile X SyndromeDrug: Placebo;Drug: RO4917523 0.5 mg;Drug: RO4917523 1.5 mgHoffmann-La RocheNULLCompleted14 Years50 YearsBoth185Phase 2United States;Argentina;Canada;Chile;France;Mexico;Peru;Spain;Sweden;United Kingdom
44EUCTR2011-002379-40-GB
(EUCTR)
24/04/201212/01/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
45EUCTR2011-002379-40-DK
(EUCTR)
28/03/201228/02/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 16.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Spain;Indonesia;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Canada;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
46EUCTR2011-001952-12-FR
(EUCTR)
21/03/201201/09/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;France;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
47EUCTR2011-002379-40-IT
(EUCTR)
19/03/201202/03/2012Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X SyndromeAn open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
180United States;Belgium;Spain;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
48EUCTR2011-001952-12-ES
(EUCTR)
08/03/201201/02/2012Seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágilEstudio abierto para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de AFQ056 en pacientes adultos con síndrome X frágil Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;France;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy
49NCT01482143
(ClinicalTrials.gov)
March 201221/11/2011Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)Sequential, Two-period Study to Assess the Pharmacokinetics, Safety & Tolerability of Single and Multiple Oral Doses of AFQ056 in Patients With FXS (Fragile X Syndrome) Aged 5-11 Years (Cohort 1) and 3-4 Years (Cohort 2)Fragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLCompleted3 Years11 YearsAll21Phase 1United States;Spain;Switzerland
50EUCTR2011-002379-40-DE
(EUCTR)
09/02/201213/12/2011Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
51EUCTR2011-002379-40-SE
(EUCTR)
09/01/201214/11/2011Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 16.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy;Switzerland;Sweden
52NCT01474746
(ClinicalTrials.gov)
January 201210/11/2011Trial of Sertraline to Treat Children With Fragile X SyndromeA Controlled Trial of Sertraline in Young Children With Fragile X SyndromeFragile X SyndromeDrug: Sertraline;Drug: PlaceboRandi J. Hagerman, MDNULLCompleted24 Months68 MonthsAll57Phase 2United States
53EUCTR2010-022638-96-ES
(EUCTR)
01/12/201118/10/2011Seguridad y eficacia de AFQ056 en pacientes adolescentes con Síndrome X Frágil.Estudio aleatorizado, doble ciego, controlado con placebo, con grupos paralelos para evaluar la eficacia y seguridad de AFQ056 en pacientes adolescentes con síndrome X frágil Síndrome X Frágil
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
54EUCTR2011-001952-12-IT
(EUCTR)
14/11/201106/03/2012Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
200United States;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy
55EUCTR2011-001952-12-DK
(EUCTR)
08/11/201114/10/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;France;Canada;Spain;Australia;Denmark;Germany;United Kingdom;Switzerland;Italy
56EUCTR2011-001952-12-GB
(EUCTR)
07/11/201121/09/2011 Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 16.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom
57EUCTR2011-001952-12-DE
(EUCTR)
03/11/201108/08/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn open-label study to evaluate the long-term safety, tolerability and efficacy of AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;France;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Switzerland;Italy
58NCT01433354
(ClinicalTrials.gov)
November 201131/8/2011Long-term, Safety and Tolerability Study of AFQ056 in Adolescent Patients With Fragile X Syndrome (Open-label)An Open-label Study to Evaluate the Long-term Safety and Tolerability of AFQ056 in Adolescent Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLTerminated12 Years18 YearsAll119Phase 2/Phase 3United States;Australia;Belgium;Denmark;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Brazil;Canada;Turkey
59NCT01555333
(ClinicalTrials.gov)
November 20111/3/2012An Open Label Extension Study in Subjects With Fragile X SyndromeAn Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subject With Fragile X SyndromeFragile X SyndromeDrug: arbaclofenSeaside Therapeutics, Inc.NULLTerminated5 Years50 YearsBoth357Phase 3United States
60EUCTR2009-013667-19-ES
(EUCTR)
06/10/201111/08/2011Seguridad y eficacia de AFQ056 en pacientes adultos con Síndrome X Frágil.Estudio aleatorizado, doble ciego, controlado con placebo, con grupos paralelos para evaluar AFQ056 en pacientes adultos con síndrome X frágil Síndrome X Frágil
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
61NCT01348087
(ClinicalTrials.gov)
August 20113/5/2011Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X SyndromeAn Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056Novartis PharmaceuticalsNULLTerminated18 YearsN/AAll148Phase 2United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom;Brazil;Netherlands
62EUCTR2010-022638-96-IT
(EUCTR)
11/07/201120/03/2012A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: AFQ056
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
180United States;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
63EUCTR2010-022638-96-GB
(EUCTR)
15/06/201121/02/2011Safety and efficacy of AFQ056in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Sweden;Germany;Netherlands;Denmark;Australia
64EUCTR2010-022638-96-SE
(EUCTR)
13/06/201104/04/2011Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Spain;Denmark;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
65NCT01325220
(ClinicalTrials.gov)
June 201128/3/2011Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X SyndromeFragile X SyndromeDrug: arbaclofen;Drug: PlaceboSeaside Therapeutics, Inc.NULLCompleted5 Years11 YearsBoth172Phase 3United States
66NCT01325740
(ClinicalTrials.gov)
May 201128/3/2011A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X SyndromeFragile X SyndromeDrug: STX107Seaside Therapeutics, Inc.NULLSuspended18 Years50 YearsMale16Phase 2United States
67NCT01282268
(ClinicalTrials.gov)
May 201120/1/2011Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X SyndromeFragile X SyndromeDrug: arbaclofen;Drug: placeboSeaside Therapeutics, Inc.NULLCompleted12 Years50 YearsBoth125Phase 3United States
68NCT01357239
(ClinicalTrials.gov)
May 201118/5/2011Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted12 Years17 YearsAll139Phase 2United States;Australia;Belgium;Canada;Denmark;France;Germany;Indonesia;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;Turkey;United Kingdom;Brazil
69EUCTR2010-022638-96-DK
(EUCTR)
27/04/201118/04/2011Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
70EUCTR2009-013667-19-DE
(EUCTR)
29/12/201002/11/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patientswith Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Switzerland
71EUCTR2009-013667-19-IT
(EUCTR)
22/12/201024/12/2010A randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome - NDA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome - ND Fragile X Syndrome
MedDRA version: 9.1;Level: PT;Classification code 10017324
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
160Spain;Denmark;Germany;United Kingdom;Italy
72EUCTR2009-013667-19-GB
(EUCTR)
15/12/201020/10/2010 Safety and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome A randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Denmark;Australia;Germany;Italy;Switzerland;United Kingdom
73NCT01329770
(ClinicalTrials.gov)
December 201029/3/2011Safety and Efficacy Study of Antioxidants for the Treatment of the Fragile X SyndromePhase II Double-blind Randomized Placebo-controlled 1-way Crossover Trial to Investigate Safety and Efficacy of the Ascorbic Acid and Tocopherol for the Treatment of the Fragile X SyndromeFragile X SyndromeDietary Supplement: Ascorbic Acid (Vitamin C) and Alpha-tocopherol (Vitamin E);Dietary Supplement: PlaceboYolanda de Diego OteroNULLCompleted6 Years18 YearsMale30Phase 2Spain
74EUCTR2009-013667-19-DK
(EUCTR)
16/11/201022/09/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate AFQ056 in adult patientswith Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160France;United States;Canada;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Switzerland
75NCT01253629
(ClinicalTrials.gov)
November 20102/12/2010Safety and Efficacy of AFQ056 in Adult Patients With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate AFQ056 in Adult Patients With Fragile X SyndromeFragile X SyndromeDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years45 YearsAll175Phase 2United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom
76NCT01300923
(ClinicalTrials.gov)
August 201025/8/2010Acamprosate in Youth With Fragile X SyndromePilot Study of Acamprosate in Youth With Fragile X SyndromeFragile X Syndrome;Autism Spectrum DisordersDrug: AcamprosateIndiana UniversityNULLCompleted5 Years17 YearsAll14Phase 2United States
77NCT01053156
(ClinicalTrials.gov)
January 201019/1/2010Trial of Minocycline to Treat Children With Fragile X SyndromeRandomized Double-Blind Controlled Cross Over Trial of Minocycline in Children With Fragile X SyndromeFragile X SyndromeDrug: minocycline hydrochloride;Drug: PlaceboUniversity of California, DavisThe National Fragile X FoundationCompleted42 Months16 YearsAll66N/AUnited States
78NCT01015430
(ClinicalTrials.gov)
November 200917/11/2009A Study With RO4917523 in Patients With Fragile X SyndromeA Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.Fragile X SyndromeDrug: Placebo (for RO4917523 ascending doses);Drug: Placebo (for RO4917523 fixed dose);Drug: RO4917523Hoffmann-La RocheNULLCompleted18 Years50 YearsBoth40Phase 2United States
79NCT01013480
(ClinicalTrials.gov)
November 200912/11/2009An Open Label Extension Study of STX209 in Subjects With Fragile X SyndromeAn Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X SyndromeFragile X SyndromeDrug: ArbaclofenSeaside Therapeutics, Inc.NULLTerminated6 Years40 YearsBoth45Phase 2United States
80NCT01120626
(ClinicalTrials.gov)
September 20097/5/2010Randomized Controlled Study of Donepezil in Fragile X SyndromeAugmentation of the Cholinergic System in Fragile X Syndrome: A Double-Blind Placebo-Controlled Randomized Study of DonepezilFragile X SyndromeDrug: donepezil;Drug: sugar pillStanford UniversityNational Institute of Mental Health (NIMH);Autism SpeaksCompleted12 Years29 YearsAll45Phase 2United States
81NCT00965432
(ClinicalTrials.gov)
September 200924/8/2009A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107Fragile X SyndromeDrug: STX107Seaside Therapeutics, Inc.National Institutes of Health (NIH)Completed18 Years50 YearsMale40Phase 1United States
82NCT00892580
(ClinicalTrials.gov)
May 20091/5/2009Biomarker and DNA Collection in Subjects Participating in Protocol 22003Biomarker Testing and DNA Collection in Subjects Participating in an Open-Label, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Autism Spectrum DisordersFragile X SyndromeDrug: STX209Seaside Therapeutics, Inc.NULLCompleted6 Years17 YearsBoth32N/AUnited States
83NCT00895752
(ClinicalTrials.gov)
April 20096/5/2009Riluzole in Fragile X SyndromeRiluzole in Fragile X Syndrome: A Pilot Study Incorporating Biomarker AssayFragile X SyndromeDrug: RiluzoleIndiana UniversityIndiana Clinical and Translational Sciences InstituteCompleted18 YearsN/AAll6Phase 4United States
84NCT00870974
(ClinicalTrials.gov)
March 200926/3/2009A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric ConditionsEvaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric ConditionsParkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive ImpairmentDrug: [18F]FPEBInstitute for Neurodegenerative DisordersNULLCompleted18 Years85 YearsAll48Phase 1United States
85NCT00823368
(ClinicalTrials.gov)
January 200913/1/2009Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X SyndromeFragile X SyndromeDrug: STX209Seaside Therapeutics, Inc.NULLCompleted6 Years40 YearsBothN/AUnited States
86NCT00788073
(ClinicalTrials.gov)
November 20087/11/2008Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X SyndromeA Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X SyndromeFragile X SyndromeDrug: STX209;Drug: PlaceboSeaside Therapeutics, Inc.NULLCompleted6 Years40 YearsAll63Phase 2United States
87EUCTR2008-003287-18-BE
(EUCTR)
17/09/200803/09/2008Functional consequences of decreased RNA expression of certain GABA(A) receptor subunits in fragile X patients using Positron Emission Tomography and [11C]flumazenil. - PET-FRAX-GABAFunctional consequences of decreased RNA expression of certain GABA(A) receptor subunits in fragile X patients using Positron Emission Tomography and [11C]flumazenil. - PET-FRAX-GABA Fragile X syndrome is the most common form of inherited mental retardation with a prevalence of 1/4000 males and 1/6000 females. Patients are characterized by a mild to severe form of cognitive impairment and light dysmorphic features. Autism-like behaviour, hyperactivity and epilepsy can also be associated with the disease. On the molecular level the disease is caused by a dynamic mutation of a CGG repeat in the 5' UTR of the FMR1 gene.Product Name: 11C-flumazenilUniversity AntwerpUniversity Hospital Leuven gasthuisbergAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
Belgium
88EUCTR2007-005088-82-IT
(EUCTR)
11/06/200809/04/2008A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in male patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 - NDA multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in male patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 - ND Fragile X Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10017324;Term: Fragile X syndrome
Product Code: AFQ056
Product Code: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: no
Male: yes
30France;Italy
89NCT00718341
(ClinicalTrials.gov)
June 200817/7/2008Efficacy, Safety and Tolerability of AFQ056 in Fragile X PatientsA Multi-centre, Randomized, Double-blind, Placebo Controlled, Two-period, Crossover Proof-of-concept Study in Male Patients With Fragile X Syndrome to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of AFQ056Fragile X SyndromeDrug: AF056;Drug: PlaceboNovartisNULLCompleted18 Years35 YearsMale30Phase 2France;Italy;Switzerland
90EUCTR2007-005088-82-FR
(EUCTR)
15/05/200820/11/2007A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of multiple oral doses of AFQ056 Fragile X Syndrome
MedDRA version: 9.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome
Product Code: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: no
Male: yes
30France;Italy
91NCT00637221
(ClinicalTrials.gov)
March 20083/3/2008Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X SyndromeAn Open Label Exploratory Study to Investigate the Safety and Effects of NPL-2009 ( 50 mg - 150 mg Single Dose) on Prepulse Inhibition Tests and Continuous Performance Tasks, in Adults With Fragile X SyndromeFragile X SyndromeDrug: NPL-2009NeuropharmNULLCompleted18 Years45 YearsBoth12Phase 1/Phase 2United States
92NCT00858689
(ClinicalTrials.gov)
October 20079/3/2009Add-on Pilot Trial of Minocycline to Treat Fragile X SyndromeAdd-on Pilot Trial of Minocycline in Fragile X SyndromeFragile X SyndromeDrug: MinocyclineFRAXA Research FoundationFragile X Research Foundation of CanadaCompleted13 Years35 YearsAll20N/ACanada
93NCT00420459
(ClinicalTrials.gov)
April 20079/1/2007A Prospective Open-label Study of Aripiprazole in Fragile X SyndromeAripiprazole in Fragile X SyndromeFragile X SyndromeDrug: AripiprazoleIndiana University School of MedicineNULLCompleted5 Years35 YearsAll12Phase 2United States
94NCT01254045
(ClinicalTrials.gov)
February 20072/12/2010Double-blind Placebo Controlled Study of Oxytocin in Fragile X SyndromeDouble-blind Placebo Controlled Study of Oxytocin in Fragile X SyndromeFragile X SyndromeDrug: placebo;Drug: oxytocin 24IU;Drug: oxytocin 48IUStanford UniversityNULLCompleted13 Years29 YearsMale10Phase 2United States
95NCT00220584
(ClinicalTrials.gov)
July 200515/9/2005An Open-Label Trial of Donepezil in Fragile X SyndromeAn Open-Label Trial of Donepezil in Fragile X SyndromeFragile X SyndromeDrug: donepezilStanford UniversityNULLCompleted14 YearsN/ABoth10Phase 1United States
96NCT00054730
(ClinicalTrials.gov)
June 20027/2/2003Effects of CX516 on Functioning in Fragile X Syndrome and AutismEffects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and AutismFragile X Syndrome;AutismDrug: CX516 (Ampalex®)Cortex PharmaceuticalsFRAXA FoundationCompleted18 Years50 YearsBothPhase 2United States
97NCT00768820
(ClinicalTrials.gov)
May 20017/10/2008The Psychiatric and Cognitive Phenotypes in Velocardiofacial SyndromeThe Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular FactorsVelocardiofacial Syndrome;Williams Syndrome;Fragile X SyndromeDrug: methylphenidate, fluoxetin, risperidoneThe Chaim Sheba Medical CenterNULLRecruitingN/AN/AAll400Phase 4Israel
98EUCTR2011-002379-40-Outside-EU/EEA
(EUCTR)
15/12/2011Long-term, safety and tolerability study of AFQ056 in adolescent patients with Fragile X Syndrome (Open–label)An open-label study to evaluate the long-term safety and tolerability of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
180Australia;Switzerland;United States
99EUCTR2010-022638-96-FR
(EUCTR)
12/04/2011A study to evaluate the efficacy of AFQ056 in treating abnormal behaviors showed by adolescents (12-17 year-old) with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 13.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
180Phase 2United States;France;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
100EUCTR2021-002542-33-IE
(EUCTR)
10/08/2021Effects and Safety of Test drug ZYN002, applied as a gel onto the skin of children and adolescents with a certain hereditary disease called Fragile X SyndromeA Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Fragile X Syndrome - RECONNECT - RECONNECT Fragile X syndrome (FXS) is a rare genetic disorder caused by the deficiency or absence of Fragile X mental retardation protein (FMRP), an RNA-binding protein and the gene product of the FMR1 gene. FXS is most commonly caused by silencing of the FMR1 gene due to a trinucleotide repeat expansion. In FXS patients, the relative absence of functional FMRP is associated with critical impairments in neurodevelopment and learning, as well as disruption to other neuronal and non-neuronal functions.
MedDRA version: 20.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: ZYN002
INN or Proposed INN: n/a
Other descriptive name: CANNABIDIOL
Zynerba Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
204Phase 3United States;Ireland;Australia;United Kingdom
101EUCTR2011-004867-65-Outside-EU/EEA
(EUCTR)
29/02/2012Clinical study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in children with Fragile X SyndromeSequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2) Fragile X Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
24Spain;United States
102EUCTR2010-022638-96-Outside-EU/EEA
(EUCTR)
31/10/2011Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome - Fragile X Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
160Australia;United States
103EUCTR2010-019353-18-Outside-EU/EEA
(EUCTR)
31/10/2011Two-period, single-dose pharmacokinetic study in male adolescent patients with Fragile X Syndrome (FXS).A sequential, open-label, two-period study to assess the pharmacokinetics, safety and tolerability of two dose levels of AFQ056 in male, adolescent patients with Fragile X Syndrome (12 to 18 years inclusive) Fragile X Syndrome
MedDRA version: 14.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNAFemale: no
Male: yes
12Switzerland
104EUCTR2010-022638-96-DE
(EUCTR)
26/04/2011Safety and efficacy of AFQ056 in adolescent patients with Fragile X SyndromeA randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety ofAFQ056 in adolescent patients with Fragile X Syndrome Fragile X Syndrome
MedDRA version: 15.0;Level: PT;Classification code 10017324;Term: Fragile X syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
160United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Canada;Australia;Denmark;Germany;Netherlands;Sweden