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：54］
Searched query = "Fragile X syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04141163 | October 29, 2019 | 4 November 2019 | Metformin in Patients With Fragile X | A 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 Biomarkers | Fragile X Syndrome | Drug: Metformin;Drug: Placebo oral tablet | Rowan University | FRAXA Research Foundation;University of Pennsylvania | Recruiting | 18 Years | 50 Years | Male | 40 | Phase 1/Phase 2 | United States |
| 2 | NCT03862950 | May 24, 2019 | 15 July 2019 | A 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 Disorders | Drug: Placebo Medication;Drug: Metformin | University of Alberta | St. Justine's Hospital | Recruiting | 6 Years | 25 Years | All | 120 | Phase 2 | Canada |
| 3 | NCT03802799 | November 9, 2018 | 3 June 2019 | Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS | An 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 Syndrome | Drug: ZYN002 - CBD Transdermal Gel | Zynerba Pharmaceuticals, Inc. | Recruiting | 3 Years | 18 Years | All | 300 | Phase 2/Phase 3 | United States;Australia;New Zealand | |
| 4 | NCT03697161 | September 17, 2018 | 7 October 2019 | A Study of OV101 in Individuals With Fragile X Syndrome | A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome | Fragile X Syndrome (FXS) | Drug: OV101 (gaboxadol) | Ovid Therapeutics Inc. | Recruiting | 13 Years | 22 Years | Male | 30 | Phase 2 | United States | |
| 5 | NCT03722290 | September 1, 2018 | 5 November 2018 | Metformin in Children and Adults With Fragile X Syndrome | Evaluate the Efficacy and Safety of Metformin in Children and Adults With Fragile X Syndrome: an Open-label Study | Fragile X Syndrome | Drug: Metformin | Université de Sherbrooke | FRAXA Research Foundation | Recruiting | 10 Years | 40 Years | All | 20 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03569631 | June 25, 2018 | 30 September 2019 | A 2-Period Crossover Study of BPN14770 in Adults Males With Fragile X Syndrome | A Randomized, Double-blind, Placebo-controlled, 2-period Crossover Study of BPN14770 in Adult Males With Fragile X Syndrome | Fragile X Syndrome;FXS;Fra(X) Syndrome | Drug: BPN14770;Drug: Placebo | Tetra Discovery Partners | Recruiting | 18 Years | 45 Years | Male | 30 | Phase 2 | United States | |
| 7 | NCT03614663 | June 12, 2018 | 3 June 2019 | Clinical 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 Syndrome | Fragile X Syndrome | Drug: ZYN002 - CBD Transdermal Gel;Other: Placebo Transdermal Gel | Zynerba Pharmaceuticals, Inc. | Recruiting | 3 Years | 17 Years | All | 204 | Phase 2/Phase 3 | United States;Australia;New Zealand | |
| 8 | NCT03479476 | April 30, 2018 | 24 June 2019 | A Trial of Metformin in Individuals With Fragile X Syndrome | A Double-Blind, Placebo-Controlled Trial of Metformin in Individuals With Fragile X Syndrome | 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 Disorders | Drug: Placebo Medication;Drug: Metformin | University of California, Davis | Recruiting | 6 Years | 25 Years | All | 60 | Phase 2/Phase 3 | United States | |
| 9 | NCT03624556 | January 29, 2018 | 26 August 2019 | Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS) | Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS) | Down Syndrome;Fragile X Syndrome | Dietary Supplement: EGCG FontUp;Other: Placebo FontUp | Parc de Salut Mar | Hospital Infantil Universitario Niño Jesús, Madrid, Spain;Instituto Hispalense de Pediatría, Sevilla, Spain;Hospital Universitario Marqués de Valdecilla;Institut Jerome Lejeune | Not recruiting | 6 Years | 12 Years | All | 70 | N/A | Spain |
| 10 | NCT03140813 | January 16, 2018 | 11 June 2018 | An Initial Study of AZD7325 in Adults With Fragile X Syndrome | An Initial Double-Blind, Placebo-Controlled Two-Dose Crossover Study of AZD7325 in Adults With Fragile X Syndrome | Fragile X Syndrome | Drug: AZD7325 (High-Dose);Drug: AZD7325 (Low-Dose);Drug: Placebo oral capsule | Children's Hospital Medical Center, Cincinnati | Recruiting | 18 Years | 50 Years | All | 15 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02920892 | August 17, 2017 | 10 September 2018 | AFQ056 for Language Learning in Children With FXS | Effects of AFQ056 on Language Learning in Young Children With Fragile X Syndrome (FXS) | Fragile X Syndrome | Drug: AFQ056;Other: Placebo;Other: Language Intervention | Elizabeth Berry-Kravis | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | 32 Months | 6 Years | All | 100 | Phase 2 | United States |
| 12 | NCT03109756 | April 3, 2017 | 16 December 2017 | Single Dose Pharmacokinetic (PK) Study | A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome | Angelman Syndrome;Fragile X Syndrome | Drug: OV101 | Ovid Therapeutics Inc. | Not recruiting | 13 Years | 17 Years | All | 12 | Phase 1 | United States | |
| 13 | EUCTR2015-005460-42-ES | 07/07/2016 | 2 October 2017 | Clinical 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 syndrome | Phase 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 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 Salud | Not Recruiting | Female: no Male: yes | Phase 3 | Spain | ||||
| 14 | NCT02942498 | July 2016 | 31 October 2016 | Clinical 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 Syndrome | Clinical 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 Syndrome | X Fragile Syndrome | Drug: Vitamin C 10mg/Kg Vitamin E 10 mg/Kg;Drug: Placebo | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Delos Clinical | Recruiting | 1 Year | 8 Years | Both | 40 | Phase 3 | Spain |
| 15 | NCT02719951 | April 2016 | 24 June 2019 | Glutaminergic Transmission in Autism : Molecular Imaging Exploration | Glutaminergic Transmission in Autism : Molecular Imaging Exploration | Autism;Fragile-X Syndrome (FXS);Healthy Volunteers | Other: Biological samples;Other: MRI;Drug: [18F]FPEB PET imaging | University Hospital, Tours | Not recruiting | 18 Years | 45 Years | Male | 27 | Phase 1 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02680379 | March 2016 | 22 October 2018 | Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome | A 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 Syndrome | Drug: Minocycline, then Minocycline/Lovastatin;Drug: Lovastatin, then Minocycline/Lovastatin | Université de Sherbrooke | FRAXA Research Foundation | Not recruiting | 8 Years | 45 Years | All | 22 | Phase 2 | Canada |
| 17 | NCT02642653 | January 2016 | 26 November 2018 | Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome | Combining Lovastatin and a Parent-Implemented Language Intervention in a Multimodal Treatment for Fragile X Syndrome | Fragile X Syndrome;Genetic Diseases | Drug: Lovastatin;Other: Placebo | University of California, Davis | Not recruiting | 10 Years | 17 Years | All | 30 | Phase 4 | United States | |
| 18 | NCT02998151 | January 2016 | 9 January 2017 | Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome | Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Acamprosate, Lovastatin, Minocycline and Placebo in Fragile X Syndrome | Fragile X Syndrome | Drug: Acamprosate;Drug: Lovastatin;Drug: Minocycline;Drug: Placebo | Children's Hospital Medical Center, Cincinnati | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Recruiting | 15 Years | 55 Years | Both | 36 | Phase 2 | United States |
| 19 | NCT02126995 | June 2014 | 21 July 2016 | A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome | A 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 Syndrome | Fragile X Syndrome | Drug: MG01CI extended-release tablet | Alcobra Ltd. | Not recruiting | 15 Years | 55 Years | Both | 62 | Phase 2 | United States;Israel | |
| 20 | NCT01894958 | January 2014 | 12 February 2018 | A Safety Study of NNZ-2566 in Patients With Fragile X Syndrome | A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose Study of NNZ-2566 in Fragile X Syndrome | Fragile X Syndrome | Drug: NNZ-2566;Drug: Placebo | Neuren Pharmaceuticals Limited | Not recruiting | 12 Years | 45 Years | Male | 72 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01855971 | June 11, 2013 | 20 May 2019 | Using 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 Syndrome | Dietary Supplement: EGCG;Dietary Supplement: Placebo;Other: Cognitive training | Parc de Salut Mar | Not recruiting | 18 Years | 60 Years | All | 44 | Phase 2 | Spain | |
| 22 | NCT01911455 | June 2013 | 25 February 2019 | Study of Acamprosate in Fragile x Syndrome | Double-Blind, Placebo-Controlled Proof of Concept Study in Youth With Fragile X Syndrome | Fragile X Syndrome | Drug: acamprosate;Drug: Placebo | Children's Hospital Medical Center, Cincinnati | Rush University Medical Center | Not recruiting | 5 Years | 23 Years | All | 48 | Phase 2/Phase 3 | United States |
| 23 | NCT01725152 | November 2012 | 25 June 2018 | Ganaxolone Treatment in Children With Fragile X Syndrome | A Controlled, Double-blind, Crossover Trial of Ganaxolone in Children With Fragile X Syndrome | Fragile x Syndrome | Drug: Ganaxolone;Drug: Placebo | Marinus Pharmaceuticals | University of California, Davis;U.S. Army Medical Research and Materiel Command | Not recruiting | 6 Years | 17 Years | All | 59 | Phase 2 | United States;Belgium |
| 24 | EUCTR2011-004349-42-GB | 16/07/2012 | 15 April 2013 | A study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome | A 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. | Authorised | Female: yes Male: yes | 180 | United States;France;Mexico;Canada;Argentina;Spain;Peru;Chile;United Kingdom;Sweden | ||||
| 25 | NCT01517698 | May 2012 | 21 July 2016 | A Study of RO4917523 in Patients With Fragile X Syndrome | A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome. | Fragile X Syndrome | Drug: Placebo;Drug: RO4917523 0.5 mg;Drug: RO4917523 1.5 mg | Hoffmann-La Roche | Not recruiting | 14 Years | 50 Years | Both | 185 | Phase 2 | United States;Argentina;Canada;Chile;France;Mexico;Peru;Spain;Sweden;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2011-002379-40-GB | 24/04/2012 | 28 February 2019 | Long-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 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 AG | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Belgium;Spain;Denmark;Australia;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | |||
| 27 | NCT01482143 | March 2012 | 19 February 2015 | Clinical 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 Syndrome | Drug: AFQ056 | Novartis Pharmaceuticals | Not recruiting | 3 Years | 11 Years | Both | 21 | Phase 1 | United States;Spain;Switzerland | |
| 28 | NCT01474746 | January 2012 | 16 December 2017 | Trial of Sertraline to Treat Children With Fragile X Syndrome | A Controlled Trial of Sertraline in Young Children With Fragile X Syndrome | Fragile X Syndrome | Drug: Sertraline;Drug: Placebo | Randi J. Hagerman, MD | Not recruiting | 24 Months | 68 Months | All | 57 | Phase 2 | United States | |
| 29 | NCT01433354 | November 2011 | 19 October 2017 | Long-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 | Drug: AFQ056 | Novartis Pharmaceuticals | Not recruiting | 12 Years | 18 Years | All | 119 | Phase 2/Phase 3 | United States;Australia;Belgium;Denmark;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Brazil;Canada;Turkey | |
| 30 | NCT01555333 | November 2011 | 19 February 2015 | An Open Label Extension Study in Subjects With Fragile X Syndrome | An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subject With Fragile X Syndrome | Fragile X Syndrome | Drug: arbaclofen | Seaside Therapeutics, Inc. | Not recruiting | 5 Years | 50 Years | Both | 357 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01348087 | August 2011 | 19 October 2017 | Long-term, Safety, Tolerability and Efficacy Study of AFQ056 in Adult Patients With Fragile X Syndrome | An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome | Fragile X Syndrome | Drug: AFQ056 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 148 | Phase 2 | United States;Australia;Canada;Denmark;France;Germany;Italy;Spain;Switzerland;United Kingdom;Brazil;Netherlands | |
| 32 | EUCTR2010-022638-96-GB | 15/06/2011 | 22 October 2012 | Safety and efficacy of AFQ056in adolescent patients with Fragile X Syndrome | A 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 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 AG | Authorised | Female: yes Male: yes | 160 | United States;France;Canada;Spain;Denmark;Australia;Israel;Germany;Switzerland;Italy;United Kingdom;Sweden | ||||
| 33 | NCT01325220 | June 2011 | 19 February 2015 | Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome | A 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 Syndrome | Fragile X Syndrome | Drug: arbaclofen;Drug: Placebo | Seaside Therapeutics, Inc. | Not recruiting | 5 Years | 11 Years | Both | 172 | Phase 3 | United States | |
| 34 | NCT01282268 | May 2011 | 19 February 2015 | Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome | A 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 Syndrome | Fragile X Syndrome | Drug: arbaclofen;Drug: placebo | Seaside Therapeutics, Inc. | Not recruiting | 12 Years | 50 Years | Both | 125 | Phase 3 | United States | |
| 35 | NCT01325740 | May 2011 | 19 February 2015 | A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome | A 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 Syndrome | Fragile X Syndrome | Drug: STX107 | Seaside Therapeutics, Inc. | Not recruiting | 18 Years | 50 Years | Male | 16 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2009-013667-19-DK | 16/11/2010 | 12 May 2014 | 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: 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 AG | Not Recruiting | Female: yes Male: yes | 160 | Switzerland;United Kingdom;Italy;Germany;Denmark;Australia;Spain;Canada;United States;France | ||||
| 37 | NCT01300923 | August 2010 | 26 August 2019 | Acamprosate in Youth With Fragile X Syndrome | Pilot Study of Acamprosate in Youth With Fragile X Syndrome | Fragile X Syndrome;Autism Spectrum Disorders | Drug: Acamprosate | Indiana University | Not recruiting | 5 Years | 17 Years | All | 14 | Phase 2 | United States | |
| 38 | NCT01053156 | January 2010 | 16 December 2017 | Trial of Minocycline to Treat Children With Fragile X Syndrome | Randomized Double-Blind Controlled Cross Over Trial of Minocycline in Children With Fragile X Syndrome | Fragile X Syndrome | Drug: minocycline hydrochloride;Drug: Placebo | University of California, Davis | The National Fragile X Foundation | Not recruiting | 42 Months | 16 Years | All | 66 | N/A | United States |
| 39 | EUCTR2010-019353-18-Outside-EU/EEA | 19 March 2012 | Two-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 AG | Not Available | Female: no Male: yes | 12 | Switzerland | |||||
| 40 | NCT01013480 | November 2009 | 19 February 2015 | An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome | An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome | Fragile X Syndrome | Drug: Arbaclofen | Seaside Therapeutics, Inc. | Not recruiting | 6 Years | 40 Years | Both | 45 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT01015430 | November 2009 | 14 November 2016 | A Study With RO4917523 in Patients With Fragile X Syndrome | A 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 Syndrome | Drug: Placebo (for RO4917523 ascending doses);Drug: Placebo (for RO4917523 fixed dose);Drug: RO4917523 | Hoffmann-La Roche | Not recruiting | 18 Years | 50 Years | Both | 40 | Phase 2 | United States | |
| 42 | NCT00965432 | September 2009 | 19 February 2015 | A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107 | A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107 | Fragile X Syndrome | Drug: STX107 | Seaside Therapeutics, Inc. | National Institutes of Health (NIH) | Not recruiting | 18 Years | 50 Years | Male | 40 | Phase 1 | United States |
| 43 | NCT01120626 | September 2009 | 19 October 2017 | Randomized Controlled Study of Donepezil in Fragile X Syndrome | Augmentation of the Cholinergic System in Fragile X Syndrome: A Double-Blind Placebo-Controlled Randomized Study of Donepezil | Fragile X Syndrome | Drug: donepezil;Drug: sugar pill | Stanford University | National Institute of Mental Health (NIMH);Autism Speaks | Not recruiting | 12 Years | 29 Years | All | 45 | Phase 2 | United States |
| 44 | NCT00892580 | May 2009 | 19 February 2015 | Biomarker and DNA Collection in Subjects Participating in Protocol 22003 | Biomarker 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 Disorders | Fragile X Syndrome | Drug: STX209 | Seaside Therapeutics, Inc. | Not recruiting | 6 Years | 17 Years | Both | 32 | N/A | United States | |
| 45 | NCT00895752 | April 2009 | 16 December 2017 | Riluzole in Fragile X Syndrome | Riluzole in Fragile X Syndrome: A Pilot Study Incorporating Biomarker Assay | Fragile X Syndrome | Drug: Riluzole | Indiana University | Indiana Clinical and Translational Sciences Institute | Not recruiting | 18 Years | N/A | All | 6 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00870974 | March 2009 | 16 December 2017 | A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions | Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions | Parkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive Impairment | Drug: [18F]FPEB | Institute for Neurodegenerative Disorders | Not recruiting | 18 Years | 85 Years | All | 48 | Phase 1 | United States | |
| 47 | NCT00823368 | January 2009 | 19 February 2015 | Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001 | Biomarker 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 Syndrome | Fragile X Syndrome | Drug: STX209 | Seaside Therapeutics, Inc. | Not recruiting | 6 Years | 40 Years | Both | N/A | United States | ||
| 48 | NCT00788073 | November 2008 | 19 October 2017 | Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome | 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 Syndrome | Fragile X Syndrome | Drug: STX209;Drug: Placebo | Seaside Therapeutics, Inc. | Not recruiting | 6 Years | 40 Years | All | 63 | Phase 2 | United States | |
| 49 | EUCTR2008-003287-18-BE | 17/09/2008 | 7 October 2014 | Functional 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 | Functional 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-flumazenil Pharmaceutical Form: Injection* | University Antwerp | University Hospital Leuven gasthuisberg | Authorised | Female: no Male: yes | Belgium | ||||
| 50 | NCT00718341 | June 2008 | 19 February 2015 | Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients | A 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 | Fragile X Syndrome | Drug: AF056;Drug: Placebo | Novartis | Not recruiting | 18 Years | 35 Years | Male | 30 | Phase 2 | France;Italy;Switzerland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2007-005088-82-FR | 15/05/2008 | 26 January 2015 | A 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 | A 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 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 AG | Not Recruiting | Female: no Male: yes | 30 | France;Italy | ||||
| 52 | NCT00637221 | March 2008 | 19 February 2015 | Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X Syndrome | An 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 Syndrome | Fragile X Syndrome | Drug: NPL-2009 | Neuropharm | Not recruiting | 18 Years | 45 Years | Both | 12 | Phase 1/Phase 2 | United States | |
| 53 | NCT00858689 | October 2007 | 19 October 2017 | Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome | Add-on Pilot Trial of Minocycline in Fragile X Syndrome | Fragile X Syndrome | Drug: Minocycline | FRAXA Research Foundation | Fragile X Research Foundation of Canada | Not recruiting | 13 Years | 35 Years | All | 20 | N/A | Canada |
| 54 | NCT00420459 | April 2007 | 16 December 2017 | A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome | Aripiprazole in Fragile X Syndrome | Fragile X Syndrome | Drug: Aripiprazole | Indiana University School of Medicine | Not recruiting | 5 Years | 35 Years | All | 12 | Phase 2 | United States | |
| 55 | NCT01254045 | February 2007 | 19 October 2017 | Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome | Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome | Fragile X Syndrome | Drug: placebo;Drug: oxytocin 24IU;Drug: oxytocin 48IU | Stanford University | Not recruiting | 13 Years | 29 Years | Male | 10 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT00220584 | July 2005 | 19 February 2015 | An Open-Label Trial of Donepezil in Fragile X Syndrome | An Open-Label Trial of Donepezil in Fragile X Syndrome | Fragile X Syndrome | Drug: donepezil | Stanford University | Not recruiting | 14 Years | N/A | Both | 10 | Phase 1 | United States | |
| 57 | NCT00054730 | June 2002 | 19 February 2015 | Effects of CX516 on Functioning in Fragile X Syndrome and Autism | Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism | Fragile X Syndrome;Autism | Drug: CX516 (Ampalex®) | Cortex Pharmaceuticals | FRAXA Foundation | Not recruiting | 18 Years | 50 Years | Both | Phase 2 | United States | |
| 58 | NCT00768820 | May 2001 | 26 August 2019 | The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome | The 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 Factors | Velocardiofacial Syndrome;Williams Syndrome;Fragile X Syndrome | Drug: methylphenidate, fluoxetin, risperidone | The Chaim Sheba Medical Center | Recruiting | N/A | N/A | All | 400 | Phase 4 | Israel |