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All Study Participants 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 and post-dose

Awards & highlights

Study 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.Check my eligibility

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.See study design

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, 60 minutes post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, 60 minutes post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 60 minutes post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate target engagement of gaboxadol treatment on high density EEG recordings

Secondary outcome measures

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 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Craig EricksonLead Sponsor

Healx LimitedIndustry Sponsor

1 Previous Clinical Trials

1 Trials studying Fragile X Syndrome

Cragi A Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of risk associated with All Study Participants for individuals participating in the trial?

"Power's team evaluation places the safety level of all study participants at 2. This is due to being in Phase 2, where there is existing data supporting safety but not yet efficacy."

Answered by AI

What is the upper limit of participants involved in this medical study?

"Indeed, data available on clinicaltrials.gov indicates an ongoing search for participants in this investigation. The trial was first listed on January 29th, 2024 and the most recent update was made on March 19th, 2024. Currently, there is a need to enroll 10 patients at one designated site."

Answered by AI

Do individuals aged 75 and above qualify for participation in this medical research study?

"This clinical investigation is seeking individuals above 18 years of age but below the age of 40 for enrollment."

Answered by AI

Are there still opportunities for individuals to participate in this research study?

"Affirmative. Information accessible on clinicaltrials.gov affirms that this investigation is actively seeking participants. Originally shared on 1/29/2024, the latest update was made on 3/19/2024. The trial aims to enroll 10 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)

Craig Erickson 2024. "Placebo-Controlled, Single-Dose Challenge Study of Gaboxadol in Adult Males With Fragile X Syndrome (FXS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06334419.

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