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Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Baclofen, Roflumilast, Memantine, and Placebo in Fragile X Syndrome

NCT05418049•Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

Summary

The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects ages 18-45, with FXS who completed the study entitled "Mechanisms and brain circuits underlying fragile X syndrome" (IRB # 2015-8425) or appropriate baseline measures through Biorepository (2013-7327).
•FXS is defined as full FMR1 mutations (\>200 CGG repeats) confirmed by genetic testing.
•General good health as determined by physical exam, medical history and laboratory work up.
•Stanford Binet IQ \<85
•Stable dosing of psychotropic drugs for at least 4 weeks.

Exclusion Criteria

•Subjects with a history of intolerance to baclofen, roflumilast, or memantine will be excluded.
•Subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or CNS neurological disease unrelated to FXS.
•Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months
•Auditory or visual impairments that cannot be corrected based on visual and auditory screener benchmarks.
•Moderate to severe renal or hepatic impairment and determined by a study physician incorporating data from exam, medical history and laboratory value evaluation among other data points.
•Use of barbiturates, benzodiazepines, antiepileptics, or other GABAergic or glutamatergic modulators
•Current use of: Amifampridine, Butalbital, Codeine, Doxylamine, Ethanol, Hydrocodone, Isocarboxazid, Kava, Metoclopramide, Midazolam, Oxybate, Phenelzine, Promethazine, Thalidomide, Tranylcypromine, Trimethobenzamide, Erythromycin, Ketoconazole, Fluvoxamine, Enoxacin, and Cimetidine.
•Those taking other psychiatric medications must be on stable doses for 4 weeks before the baseline visit.
•Pregnancy or breast-feeding. For female subjects of child bearing potential, a urine pregnancy test will be performed.
•Potential subjects with a creatinine clearance \< 50 mL/min will be excluded.
+1 more criteria

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

September 8, 2022

Primary Completion Date

October 28, 2025

Completion Date

March 5, 2026

Last Updated

December 23, 2025

Enrollment

ESTIMATED participants

Conditions

Fragile X Syndrome

Interventions

Baclofen

DRUG

Memantine

DRUG

Roflumilast

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Effects and Safety of SPG601 for the Treatment of Fragile X Syndrome in Male Participants

Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals with Fragile-X Syndrome

Study of SPG601 in Adult Men With Fragile X Syndrome

An Investigation of Psilocybin on Behavioural and Cognitive Symptoms of Adults With Fragile X Syndrome

Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)

An Initial Study of AZD7325 in Adults With Fragile X Syndrome