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

Fragile X Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01325740
• Other study ID #: 107FX201
• Status: Suspended
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: December 19, 2012
• Start date: May 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2012
• Source: Seaside Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 16
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fragile X Syndrome
• Syndrome

Intervention

Drug:
• STX107
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

Locations

Country	Name	City	State
United States	University of Colorado Denver, Children's Hospital	Aurora	Colorado
United States	Rush University Medical Center	Chicago	Illinois
United States	Emory University School of Medicine	Decatur	Georgia
United States	University of California-Los Angeles Neuropsychiatric Institute	Los Angeles	California
United States	University of California-Davis, M.I.N.D. Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Seaside Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events will be monitored for tolerability	physical exam, laboratories, collection of adverse events	1 day	Yes
Secondary	Blood levels of STX107 will be measured to define pharmacokinetics		1 day	No