Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
NCT ID: NCT05418049
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2022-09-08
2026-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Experimental Study Participants
Participants received, in random order, a single dose of placebo, baclofen, roflumilast or memantine with a two-week washout period between doses.
Baclofen
30mg - Supplied as 10mg and 20mg tablets
Memantine
two 10 mg tablets
Roflumilast
250 mcg capsule
Control Study Participants
Participants received, in random order, a single dose of placebo, baclofen, roflumilast or memantine with a two-week washout period between doses.
Placebo
Placebo pill
Interventions
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Baclofen
30mg - Supplied as 10mg and 20mg tablets
Memantine
two 10 mg tablets
Roflumilast
250 mcg capsule
Placebo
Placebo pill
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
* Identified medical issues, inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.
18 Years
45 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Craig A. Erickson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2022-0202
Identifier Type: -
Identifier Source: org_study_id