A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

Phase 2

Suspended

• Conditions: Fragile X Syndrome
• Interventions: Drug: STX107

• Registration Number: NCT01325740
• Lead Sponsor: Seaside Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-30
• Study Start: 2011-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Male subjects 18 to 50 years of age, inclusive.
• Molecular documentation of the full fragile X mutation.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STX107 10 mg	STX107	-
Placebo	STX107	-
STX107 30 mg	STX107	-

Primary Outcome Measures

Name	Time	Method
Adverse events will be monitored for tolerability	1 day	physical exam, laboratories, collection of adverse events

Secondary Outcome Measures

Name	Time	Method
Blood levels of STX107 will be measured to define pharmacokinetics	1 day

Trial Locations

Locations (5)

University of California-Davis, M.I.N.D. Institute; 🇺🇸 Sacramento, California, United States

University of Colorado Denver, Children's Hospital; 🇺🇸 Aurora, Colorado, United States

University of California-Los Angeles Neuropsychiatric Institute; 🇺🇸 Los Angeles, California, United States

Emory University School of Medicine; 🇺🇸 Decatur, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States