A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
Paused · Phase 2 · Has a placebo group
Conditions studied: Fragile X Syndrome
In brief
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
Key facts
- Study ID
- NCT01325740
- Run by
- Seaside Therapeutics, Inc.
- People needed
- 16
- Starts
- 2011-05-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2012-12-20
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Male subjects 18 to 50 years of age, inclusive.
- Molecular documentation of the full fragile X mutation.
You may not qualify if…
- Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
- Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
- Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- Subjects who, in the Investigator's opinion, might not be suitable for the study
Where it is running
- University of California-Los Angeles Neuropsychiatric Institute — Los Angeles, California, United States
- University of California-Davis, M.I.N.D. Institute — Sacramento, California, United States
- University of Colorado Denver, Children's Hospital — Aurora, Colorado, United States
- Emory University School of Medicine — Decatur, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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