Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05418049
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Fragile X Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Baclofen — DRUG
    30mg - Supplied as 10mg and 20mg tablets
  • Memantine — DRUG
    two 10 mg tablets
  • Roflumilast — DRUG
    250 mcg capsule
  • Placebo — DRUG
    Placebo pill

Study Details

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.

Key Dates

Start date
Sep 8, 2022
Status verified
Nov 2025
Primary completion
Oct 28, 2025
Completion
Mar 5, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Change in EEG Relative Gamma Power [ Time Frame: Pre-dose, 3-hour post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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