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Showing 1–24 of 88 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Fragile X Syndrome Clear all
Completed Phase 2 Interventional

A Study of RO4917523 in Patients With Fragile X Syndrome

NCT01517698
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Placebo, RO4917523 0.5 mg, RO4917523 1.5 mg
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
14 Years to 50 Years
Enrollment
185 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
20
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 17 more
Source: ClinicalTrials.gov public record
Updated Jul 10, 2016 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Randomized Controlled Study of Donepezil in Fragile X Syndrome

NCT01120626
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
donepezil, sugar pill
Drug
Lead sponsor
Stanford University
Other
Eligibility
12 Years to 29 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Mar 16, 2016 · Synced Sep 5, 2026, 1:27 AM EDT
Completed No phase listed Observational

Biomarker and DNA Collection in Subjects Participating in Protocol 22003

NCT00892580
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
STX209
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 17 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2009
U.S. locations
8
States / cities
Phoenix, Arizona • Los Angeles, California • New Haven, Connecticut + 5 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2013 · Synced Sep 5, 2026, 1:27 AM EDT
Terminated Phase 2 Interventional

An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

NCT01013480
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Arbaclofen
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
9
States / cities
Los Angeles, California • Sacramento, California • Chicago, Illinois + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 19, 2012 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome

NCT01357239
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
AFQ056, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 17 Years
Enrollment
139 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
8
States / cities
Sacramento, California • Decatur, Georgia • Chicago, Illinois + 5 more
Source: ClinicalTrials.gov public record
Updated May 11, 2015 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 1 Interventional

Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)

NCT01482143
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
AFQ056
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
3 Years to 11 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
3
States / cities
Sacramento, California • Chicago, Illinois • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 7, 2020 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

A Study of OV101 in Individuals With Fragile X Syndrome

NCT03697161
View directory record Official record
Conditions
Fragile X Syndrome (FXS)
Interventions
OV101 (gaboxadol)
Drug
Lead sponsor
Healx AI
Industry
Eligibility
13 Years to 22 Years · Male only
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
6
States / cities
Sacramento, California • Aurora, Colorado • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 22, 2024 · Synced Sep 5, 2026, 1:27 AM EDT
Not listed No phase listed Observational Accepts healthy volunteers

Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome

NCT04869930
View directory record Official record
Conditions
Autism Spectrum Disorder, Fra(X) Syndrome
Interventions
specimen collection
Other
Lead sponsor
Nova Mentis Life Science Corp
Industry
Eligibility
6 Months to 21 Years
Enrollment
300 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
1
States / cities
Fort Lauderdale, Florida
Source: ClinicalTrials.gov public record
Updated Oct 12, 2021 · Synced Sep 5, 2026, 1:27 AM EDT
Completed No phase listed Observational

Protein Synthesis in the Brain of Patients With Fragile X Syndrome

NCT00362843
View directory record Official record
Conditions
Fragile X Syndrome, Healthy Volunteers
Interventions
[15-O]water
Drug
Lead sponsor
National Institute of Mental Health (NIMH)
NIH
Eligibility
18 Years to 24 Years · Male only
Enrollment
147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2020
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 7, 2024 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Ganaxolone Treatment in Children With Fragile X Syndrome

NCT01725152
View directory record Official record
Conditions
Fragile x Syndrome
Interventions
Ganaxolone, Placebo
Drug
Lead sponsor
Marinus Pharmaceuticals
Industry
Eligibility
6 Years to 17 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Apr 9, 2023 · Synced Sep 5, 2026, 1:27 AM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders

NCT06227780
View directory record Official record
Conditions
Fragile X Syndrome, Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
Interventions
Alpha Auditory Entrainment, Sham
Other
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
5 Years to 10 Years
Enrollment
180 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2028
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 29, 2026 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone

NCT02603926
View directory record Official record
Conditions
Fragile X-associated Tremor/Ataxia Syndrome
Interventions
Allopregnanolone
Drug
Lead sponsor
Randi J. Hagerman, MD
Other
Eligibility
50 Years to 85 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Dec 5, 2018 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Not applicable Interventional

Treatment of Disruptive Behaviors in Fragile X Syndrome

NCT03510156
View directory record Official record
Conditions
Fragile X Syndrome, Disruptive Behavior
Interventions
Behavior analytic treatment
Behavioral
Lead sponsor
Stanford University
Other
Eligibility
3 Years to 10 Years · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated May 3, 2022 · Synced Sep 5, 2026, 1:27 AM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

Speech-in-noise Perception in Autism and Fragile X

NCT06088589
View directory record Official record
Conditions
Autism Spectrum Disorder, Fragile X Syndrome
Interventions
Mismatch negativity
Behavioral
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
15 Years to 35 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2026
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Mar 18, 2026 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

AFQ056 for Language Learning in Children With FXS

NCT02920892
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
AFQ056, Placebo, Language Intervention
Drug · Other
Lead sponsor
Elizabeth Berry-Kravis
Other
Eligibility
32 Months to 6 Years
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
14
States / cities
Davis, California • Denver, Colorado • New Haven, Connecticut + 11 more
Source: ClinicalTrials.gov public record
Updated Oct 9, 2023 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Trial of Sertraline to Treat Children With Fragile X Syndrome

NCT01474746
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Sertraline, Placebo
Drug
Lead sponsor
Randi J. Hagerman, MD
Other
Eligibility
24 Months to 68 Months
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Sep 24, 2017 · Synced Sep 5, 2026, 1:27 AM EDT
Recruiting No phase listed Observational

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

NCT07493096
View directory record Official record
Conditions
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder), Cerebral Palsy (CP), Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment, Cerebral Palsy Infantile, Cerebral Palsy Spastic Hemiplegic, Cerebral Palsy, Dyskinetic, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD, Hypoxic Ischemic Encephalopathy, Hypoxic Ischemic Encephalopathy (HIE), Traumatic Brain Injury (TBI), Sensory Processing Disorder, Chromosomal Abnormalities, Genetic Disorders, Down Syndrome (Trisomy 21), Fragile X Syndrome (FXS), RETT Syndrome With Proven MECP2 Mutation, Williams Syndrome, 22q11.2 Deletion Syndrome, Sensorimotor Integration
Interventions
Not listed
Lead sponsor
Healing Hope International
Other
Eligibility
4 Years to 12 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2036
U.S. locations
1
States / cities
The Woodlands, Texas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2026 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 1 Interventional

An Initial Study of AZD7325 in Adults With Fragile X Syndrome

NCT03140813
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
AZD7325 (High-Dose), AZD7325 (Low-Dose), Placebo oral capsule
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
18 Years to 50 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 7, 2021 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Diaphragmatic Breathing and Heart Rate Variability Training for Improving Hypertension in Fragile X Associated Tremor/Ataxia

NCT03816540
View directory record Official record
Conditions
Hypertension, FXTAS
Interventions
HRV and respiratory coherence biofeedback
Device
Lead sponsor
University of California, Davis
Other
Eligibility
50 Years to 90 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2019
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Oct 21, 2019 · Synced Sep 5, 2026, 1:27 AM EDT
Withdrawn Phase 2 Interventional

Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40

NCT04823052
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Sulindac (HLX-0201), dose strength 1, Sulindac (HLX-0201), dose strength 2, Placebo, Gaboxadol (HLX-0206)
Drug
Lead sponsor
Healx Limited
Industry
Eligibility
13 Years to 40 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022
U.S. locations
7
States / cities
Aurora, Colorado • Miami, Florida • Atlanta, Georgia + 4 more
Source: ClinicalTrials.gov public record
Updated Dec 7, 2022 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107

NCT00965432
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
STX107
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
18 Years to 50 Years · Male only
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2010
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Feb 7, 2010 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers Results available

Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

NCT00584948
View directory record Official record
Conditions
Fragile X-Associated Tremor/Ataxia Syndrome, Fragile X Premutation Carriers
Interventions
Memantine, Placebo
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
30 Years to 80 Years
Enrollment
94 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2012
U.S. locations
2
States / cities
Sacramento, California • Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated May 29, 2017 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 4 Interventional Results available

Riluzole in Fragile X Syndrome

NCT00895752
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Riluzole
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Apr 17, 2017 · Synced Sep 5, 2026, 1:27 AM EDT
Completed Phase 2 Interventional Results available

Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome

NCT02197104
View directory record Official record
Conditions
Fragile X Tremor/Ataxia Syndrome
Interventions
citocoline
Drug
Lead sponsor
Rush University Medical Center
Other
Eligibility
18 Years to 90 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Nov 1, 2022 · Synced Sep 5, 2026, 1:27 AM EDT