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

Seaside Therapeutics

Status and phase

Suspended

Phase 2

Conditions

Fragile X Syndrome

Treatments

Drug: STX107

Study type

Interventional

Funder types

Industry

Identifiers

NCT01325740

107FX201

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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