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ClinicalTrials.gov public records Last synced Sep 11, 2026, 11:47 AM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: FXS Clear all
Completed Early Phase 1 Interventional Results available

Neurophysiological and Acute Pharmacological Studies in FXS Patients

NCT02998151
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Acamprosate, Lovastatin, Minocycline, Placebo, Baclofen
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
15 Years to 55 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 25, 2021 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 2 Interventional Results available

Acamprosate in Youth With Fragile X Syndrome

NCT01300923
View directory record Official record
Conditions
Fragile X Syndrome, Autism Spectrum Disorders
Interventions
Acamprosate
Drug
Lead sponsor
Indiana University
Other
Eligibility
5 Years to 17 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Jul 29, 2019 · Synced Sep 11, 2026, 11:47 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 11, 2026, 11:47 AM EDT
Completed Phase 2Phase 3 Interventional

A Randomized Study of BPN14770 in Male Adolescents (Aged 9 to < 18 Years) With Fragile X Syndrome

NCT05163808
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
zatolmilast, Placebo
Drug
Lead sponsor
Tetra Discovery Partners
Industry
Eligibility
9 Years to 18 Years · Male only
Enrollment
163 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
17
States / cities
Irvine, California • Orange, California • Sacramento, California + 14 more
Source: ClinicalTrials.gov public record
Updated Aug 30, 2026 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 3 Interventional

Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome

NCT04977986
View directory record Official record
Conditions
Fragile X Syndrome, Fragile X Syndrome (FXS)
Interventions
ZYN002, Placebo
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
3 Years to 29 Years
Enrollment
257 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
18
States / cities
Phoenix, Arizona • Culver City, California • Irvine, California + 15 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 1 Interventional

An Open-Label Trial of Donepezil in Fragile X Syndrome

NCT00220584
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
donepezil
Drug
Lead sponsor
Stanford University
Other
Eligibility
14 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Dec 12, 2012 · Synced Sep 11, 2026, 11:47 AM EDT
Withdrawn Phase 1 Interventional Accepts healthy volunteers

Novel Clinical Target in Fragile X Syndrome

NCT04314856
View directory record Official record
Conditions
Fragile X Syndrome (FXS)
Interventions
18F-FTC-146
Drug
Lead sponsor
Guido A. Davidzon, MD, SM
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Nov 14, 2022 · Synced Sep 11, 2026, 11:47 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 11, 2026, 11:47 AM EDT
Suspended Phase 2 Interventional

A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

NCT01325740
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
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
5
States / cities
Los Angeles, California • Sacramento, California • Aurora, Colorado + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 19, 2012 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of Acamprosate in Fragile x Syndrome

NCT01911455
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
acamprosate, Placebo
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
5 Years to 23 Years
Enrollment
46 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2018
U.S. locations
2
States / cities
Chicago, Illinois • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 2, 2021 · Synced Sep 11, 2026, 11:47 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 11, 2026, 11:47 AM EDT
Completed Phase 3 Interventional

A Study of BPN14770 in Male Adults (Aged 18 to 45) With Fragile X Syndrome

NCT05358886
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
BPN14770/ zatolmilast, Placebo
Drug
Lead sponsor
Tetra Discovery Partners
Industry
Eligibility
18 Years to 45 Years · Male only
Enrollment
171 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
17
States / cities
Irvine, California • Orange, California • Sacramento, California + 14 more
Source: ClinicalTrials.gov public record
Updated Jul 9, 2026 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 3 Interventional

Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

NCT01282268
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
arbaclofen, placebo
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
12 Years to 50 Years
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2011
U.S. locations
24
States / cities
Phoenix, Arizona • Long Beach, California • Sacramento, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2013 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 2 Interventional

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

NCT01253629
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
AFQ056, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 45 Years
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
12
States / cities
Phoenix, Arizona • Sacramento, California • Decatur, Georgia + 9 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2020 · Synced Sep 11, 2026, 11:47 AM EDT
Active, not recruiting Phase 3 Interventional

An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome

NCT05367960
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Zatolmilast/ BPN14770
Drug
Lead sponsor
Tetra Discovery Partners
Industry
Eligibility
9 Years to 45 Years · Male only
Enrollment
314 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
17
States / cities
Irvine, California • Orange, California • Sacramento, California + 14 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2025 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 2 Interventional

Effects of CX516 on Functioning in Fragile X Syndrome and Autism

NCT00054730
View directory record Official record
Conditions
Fragile X Syndrome, Autism
Interventions
CX516 (Ampalex®)
Drug
Lead sponsor
RespireRx
Industry
Eligibility
18 Years to 50 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2002
U.S. locations
2
States / cities
Sacramento, California • Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Sep 11, 2026, 11:47 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 11, 2026, 11:47 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions

NCT00870974
View directory record Official record
Conditions
Parkinson Disease, Huntington Disease, Autistic Spectrum Disorders, Fragile X Syndrome, Alzheimer Disease, Mild Cognitive Impairment
Interventions
[18F]FPEB
Drug
Lead sponsor
Institute for Neurodegenerative Disorders
Other
Eligibility
18 Years to 85 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Jan 5, 2017 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Clinical Study Of caNNabidiol in childrEn and adolesCenTs With Fragile X (CONNECT-FX)

NCT03614663
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
ZYN002 - Cannabidiol Transdermal Gel, Placebo Transdermal Gel
Drug · Other
Lead sponsor
Zynerba Pharmaceuticals, Inc.
Industry
Eligibility
3 Years to 17 Years
Enrollment
212 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
17
States / cities
Phoenix, Arizona • Sacramento, California • Denver, Colorado + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 5, 2022 · Synced Sep 11, 2026, 11:47 AM EDT
Completed Phase 1Phase 2 Interventional

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

NCT00637221
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
NPL-2009
Drug
Lead sponsor
Neuropharm
Industry
Eligibility
18 Years to 45 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
2
States / cities
Sacramento, California • Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 26, 2012 · Synced Sep 11, 2026, 11:47 AM EDT
Recruiting Phase 2 Interventional

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

NCT07209462
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Low dose of MRM-3379, Middle Dose of MRM-3379, High dose of MRM-3379, Placebo, Low dose of MRM-3379 Open-Label
Drug
Lead sponsor
Mirum Pharmaceuticals, Inc.
Industry
Eligibility
13 Years to 45 Years · Male only
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
15
States / cities
Phoenix, Arizona • Irvine, California • Orange, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 23, 2026 · Synced Sep 11, 2026, 11:47 AM EDT
Enrolling by invitation Phase 1 Interventional

Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities

NCT05301361
View directory record Official record
Conditions
Intellectual Disability, Fragile X Syndrome, Down Syndrome, Attention Deficit Hyperactivity Disorder
Interventions
Methylphenidate Oral Solution
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
6 Years to 24 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
3
States / cities
Sacramento, California • Chicago, Illinois • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 14, 2025 · Synced Sep 11, 2026, 11:47 AM EDT
Completed No phase listed Observational

Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

NCT00823368
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
STX209
Drug
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Eligibility
6 Years to 40 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2009
U.S. locations
11
States / cities
Phoenix, Arizona • Los Angeles, California • Sacramento, California + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2013 · Synced Sep 11, 2026, 11:47 AM EDT
Terminated No phase listed Observational

The Natural History of Reproductive and Overall Health in Girls and Women With a Pre-Mutation in the FMR1 Gene; Creation of a Patient Registry

NCT01187524
View directory record Official record
Conditions
Fragile X Syndrome, FMR1 Premutation, Primary Ovairan Insufficiency, Premature Ovarian Failure, Premature Menopause
Interventions
Not listed
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Eligibility
18 Years and older · Female only
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 5, 2017 · Synced Sep 11, 2026, 11:47 AM EDT