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Gaboxadol for Fragile X Syndrome
Phase 2
Recruiting
Led By Cragi A Erickson, MD
Research Sponsored by Craig Erickson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 60 minutes post-dose
Summary
This trial will involve male participants aged 18 to 40 with Fragile X Syndrome. They will have four visits, two at home and two in clinic, each 14 days apart. At each
Who is the study for?
This trial is for adult males aged 18 to 40 with Fragile X Syndrome. Participants will have a series of four visits, two at home and two in clinic, each spaced out by two weeks. They must be able to take oral medication.
What is being tested?
The study tests the effects of a single dose of Gaboxadol (10 mg) compared to a placebo. Each participant will receive both the actual drug and placebo in different visits without knowing which one they are taking.
What are the potential side effects?
Potential side effects are not specified here but generally could include drowsiness, headache, nausea or other reactions common with new medications taken orally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate target engagement of gaboxadol treatment on high density EEG recordings
Secondary study objectives
To determine whether FMRP levels predict treatment response
To investigate the effect of gaboxadol treatment on clinician-rated measures
To investigate the effect of gaboxadol treatment on eye tracking assessments
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: All Study ParticipantsExperimental Treatment2 Interventions
Participants received, in random order, a single dose of placebo or Gaboxadol with a two-week washout period between doses. The gaboxadol dosage selected for this study is 10 mg or Placebo as a single dose on each study visit (two at home and two in clinic).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gaboxadol
2019
Completed Phase 3
~110
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Craig EricksonLead Sponsor
Healx LimitedIndustry Sponsor
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Fragile X Syndrome
Cragi A Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati