Trials / Active Not Recruiting
Active Not RecruitingNCT05418049
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baclofen | 30mg - Supplied as 10mg and 20mg tablets |
| DRUG | Memantine | two 10 mg tablets |
| DRUG | Roflumilast | 250 mcg capsule |
| DRUG | Placebo | Placebo pill |
Timeline
- Start date
- 2022-09-08
- Primary completion
- 2025-10-28
- Completion
- 2026-03-05
- First posted
- 2022-06-14
- Last updated
- 2025-12-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05418049. Inclusion in this directory is not an endorsement.