A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome

Seaside Therapeutics, Inc.5 sites in 1 country16 target enrollmentMay 2011

ConditionsFragile X Syndrome

InterventionsSTX107

DrugsSTX107

Overview

Phase: Phase 2
Intervention: STX107
Conditions: Fragile X Syndrome
Sponsor: Seaside Therapeutics, Inc.
Enrollment: 16
Locations: 5
Primary Endpoint: Adverse events will be monitored for tolerability
Status: Suspended
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

September 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Seaside Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.
•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