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 206. 脆弱X症候群 [臨床試験数:58,薬物数:58(DrugBank:25),標的遺伝子数:44,標的パスウェイ数:16] 

Searched query = "Fragile X syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT04141163October 29, 20194 November 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
2NCT03862950May 24, 201915 July 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 Years25 YearsAll120Phase 2Canada
3NCT03802799November 9, 20183 June 2019Open 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.Recruiting3 Years18 YearsAll300Phase 2/Phase 3United States;Australia;New Zealand
4NCT03697161September 17, 20187 October 2019A 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.Recruiting13 Years22 YearsMale30Phase 2United States
5NCT03722290September 1, 20185 November 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 FoundationRecruiting10 Years40 YearsAll20Phase 2Canada
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
6NCT03569631June 25, 201830 September 2019A 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 PartnersRecruiting18 Years45 YearsMale30Phase 2United States
7NCT03614663June 12, 20183 June 2019Clinical 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.Recruiting3 Years17 YearsAll204Phase 2/Phase 3United States;Australia;New Zealand
8NCT03479476April 30, 201824 June 2019A 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, DavisRecruiting6 Years25 YearsAll60Phase 2/Phase 3United States
9NCT03624556January 29, 201826 August 2019Pediatric 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 LejeuneNot recruiting6 Years12 YearsAll70N/ASpain
10NCT03140813January 16, 201811 June 2018An 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, CincinnatiRecruiting18 Years50 YearsAll15Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
11NCT02920892August 17, 201710 September 2018AFQ056 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)Recruiting32 Months6 YearsAll100Phase 2United States
12NCT03109756April 3, 201716 December 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.Not recruiting13 Years17 YearsAll12Phase 1United States
13EUCTR2015-005460-42-ES07/07/20162 October 2017Clinical 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 syndromeFragile 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
Pharmaceutical Form: Oral solution
INN or Proposed INN: Vitamin C
Other descriptive name: ACIDUM ASCORBICUM D6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Vitamin E
Pharmaceutical Form: Oral solution
INN or Proposed INN: Vitamin E
CAS Number: 58-95-7
Other descriptive name: TOCOPHERYL ACETATE
Concentration unit: millilitre(s)/gram
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludNot RecruitingFemale: no
Male: yes
Phase 3Spain
14NCT02942498July 201631 October 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
15NCT02719951April 201624 June 2019Glutaminergic Transmission in Autism : Molecular Imaging ExplorationGlutaminergic Transmission in Autism : Molecular Imaging ExplorationAutism;Fragile-X Syndrome (FXS);Healthy VolunteersOther: Biological samples;Other: MRI;Drug: [18F]FPEB PET imagingUniversity Hospital, ToursNot recruiting18 Years45 YearsMale27Phase 1France
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
16NCT02680379March 201622 October 2018Combined 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 FoundationNot recruiting8 Years45 YearsAll22Phase 2Canada
17NCT02642653January 201626 November 2018Combining 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, DavisNot recruiting10 Years17 YearsAll30Phase 4United States
18NCT02998151January 20169 January 2017Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X SyndromeEvaluating the Neurophysiologic and Clinical Effects of Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X SyndromeFragile X SyndromeDrug: Acamprosate;Drug: Lovastatin;Drug: Minocycline;Drug: PlaceboChildren's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Recruiting15 Years55 YearsBoth36Phase 2United States
19NCT02126995June 201421 July 2016A 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.Not recruiting15 Years55 YearsBoth62Phase 2United States;Israel
20NCT01894958January 201412 February 2018A 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 LimitedNot recruiting12 Years45 YearsMale72Phase 2United States
No.TrialIDDate_
enrollement
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PhaseCountries
21NCT01855971June 11, 201320 May 2019Using 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 MarNot recruiting18 Years60 YearsAll44Phase 2Spain
22NCT01911455June 201325 February 2019Study 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 CenterNot recruiting5 Years23 YearsAll48Phase 2/Phase 3United States
23NCT01725152November 201225 June 2018Ganaxolone 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 Materiel CommandNot recruiting6 Years17 YearsAll59Phase 2United States;Belgium
24EUCTR2011-004349-42-GB16/07/201215 April 2013A 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
Pharmaceutical Form: Capsule
Current Sponsor code: RO4917523
Other descriptive name: mGlu5 antagonist
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: mGlu5 antagonist
Product Code: Ro 491-7523/F19
Pharmaceutical Form: Capsule
Current Sponsor code: RO4917523
Other descriptive name: mGlu5 antagonist
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
F. Hoffmann-La Roche Ltd.AuthorisedFemale: yes
Male: yes
180United States;France;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden
25NCT01517698May 201221 July 2016A 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 RocheNot recruiting14 Years50 YearsBoth185Phase 2United States;Argentina;Canada;Chile;France;Mexico;Peru;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
26EUCTR2011-002379-40-GB24/04/201228 February 2019Long-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 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
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Novartis Pharma Services AGNot Recruiting Female: yes
Male: yes
180Phase 2France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
27NCT01482143March 201219 February 2015Clinical 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 PharmaceuticalsNot recruiting3 Years11 YearsBoth21Phase 1United States;Spain;Switzerland
28NCT01474746January 201216 December 2017Trial 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, MDNot recruiting24 Months68 MonthsAll57Phase 2United States
29NCT01433354November 201119 October 2017Long-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 PharmaceuticalsNot recruiting12 Years18 YearsAll119Phase 2/Phase 3United States;Australia;Belgium;Denmark;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Brazil;Canada;Turkey
30NCT01555333November 201119 February 2015An 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.Not recruiting5 Years50 YearsBoth357Phase 3United States
No.TrialIDDate_
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31NCT01348087August 201119 October 2017Long-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 PharmaceuticalsNot recruiting18 YearsN/AAll148Phase 2United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom;Brazil;Netherlands
32EUCTR2010-022638-96-GB15/06/201122 October 2012Safety 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 SyndromeFragile 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
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
160United States;France;Canada;Spain;Denmark;Australia;Israel;Germany;Switzerland;Italy;United Kingdom;Sweden
33NCT01325220June 201119 February 2015Efficacy 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.Not recruiting5 Years11 YearsBoth172Phase 3United States
34NCT01282268May 201119 February 2015Efficacy 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.Not recruiting12 Years50 YearsBoth125Phase 3United States
35NCT01325740May 201119 February 2015A 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.Not recruiting18 Years50 YearsMale16Phase 2United States
No.TrialIDDate_
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36EUCTR2009-013667-19-DK16/11/201012 May 2014Safety 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 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
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
160Switzerland;United Kingdom;Italy;Germany;Denmark;Australia;Spain;Canada;United States;France
37NCT01300923August 201026 August 2019Acamprosate in Youth With Fragile X SyndromePilot Study of Acamprosate in Youth With Fragile X SyndromeFragile X Syndrome;Autism Spectrum DisordersDrug: AcamprosateIndiana UniversityNot recruiting5 Years17 YearsAll14Phase 2United States
38NCT01053156January 201016 December 2017Trial 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 FoundationNot recruiting42 Months16 YearsAll66N/AUnited States
39EUCTR2010-019353-18-Outside-EU/EEA19 March 2012Two-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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot AvailableFemale: no
Male: yes
12Switzerland
40NCT01013480November 200919 February 2015An 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.Not recruiting6 Years40 YearsBoth45Phase 2United States
No.TrialIDDate_
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41NCT01015430November 200914 November 2016A 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 RocheNot recruiting18 Years50 YearsBoth40Phase 2United States
42NCT00965432September 200919 February 2015A 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)Not recruiting18 Years50 YearsMale40Phase 1United States
43NCT01120626September 200919 October 2017Randomized 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 SpeaksNot recruiting12 Years29 YearsAll45Phase 2United States
44NCT00892580May 200919 February 2015Biomarker 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.Not recruiting6 Years17 YearsBoth32N/AUnited States
45NCT00895752April 200916 December 2017Riluzole in Fragile X SyndromeRiluzole in Fragile X Syndrome: A Pilot Study Incorporating Biomarker AssayFragile X SyndromeDrug: RiluzoleIndiana UniversityIndiana Clinical and Translational Sciences InstituteNot recruiting18 YearsN/AAll6Phase 4United States
No.TrialIDDate_
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PhaseCountries
46NCT00870974March 200916 December 2017A 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 DisordersNot recruiting18 Years85 YearsAll48Phase 1United States
47NCT00823368January 200919 February 2015Biomarker 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.Not recruiting6 Years40 YearsBothN/AUnited States
48NCT00788073November 200819 October 2017Safety, 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.Not recruiting6 Years40 YearsAll63Phase 2United States
49EUCTR2008-003287-18-BE17/09/20087 October 2014Functional 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-GABAFragile 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-flumazenil
Pharmaceutical Form: Injection*
University AntwerpUniversity Hospital Leuven gasthuisbergAuthorisedFemale: no
Male: yes
Belgium
50NCT00718341June 200819 February 2015Efficacy, 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: PlaceboNovartisNot recruiting18 Years35 YearsMale30Phase 2France;Italy;Switzerland
No.TrialIDDate_
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on
Public_titleScientific_titleConditionInterventionPrimary_
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51EUCTR2007-005088-82-FR15/05/200826 January 2015A 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 AFQ056Fragile X Syndrome
MedDRA version: 9.1 Level: PT Classification code 10017324 Term: Fragile X syndrome
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: no
Male: yes
30France;Italy
52NCT00637221March 200819 February 2015Open 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-2009NeuropharmNot recruiting18 Years45 YearsBoth12Phase 1/Phase 2United States
53NCT00858689October 200719 October 2017Add-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 CanadaNot recruiting13 Years35 YearsAll20N/ACanada
54NCT00420459April 200716 December 2017A Prospective Open-label Study of Aripiprazole in Fragile X SyndromeAripiprazole in Fragile X SyndromeFragile X SyndromeDrug: AripiprazoleIndiana University School of MedicineNot recruiting5 Years35 YearsAll12Phase 2United States
55NCT01254045February 200719 October 2017Double-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 UniversityNot recruiting13 Years29 YearsMale10Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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agemax
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PhaseCountries
56NCT00220584July 200519 February 2015An Open-Label Trial of Donepezil in Fragile X SyndromeAn Open-Label Trial of Donepezil in Fragile X SyndromeFragile X SyndromeDrug: donepezilStanford UniversityNot recruiting14 YearsN/ABoth10Phase 1United States
57NCT00054730June 200219 February 2015Effects 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 FoundationNot recruiting18 Years50 YearsBothPhase 2United States
58NCT00768820May 200126 August 2019The 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 CenterRecruitingN/AN/AAll400Phase 4Israel

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