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

This study has suspended participant recruitment.
(pending further evaluation)
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01325740
First received: March 28, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fragile X Syndrome
 Drug: STX107
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:
  • Adverse events will be monitored for tolerability [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    physical exam, laboratories, collection of adverse events


Secondary Outcome Measures:
  • Blood levels of STX107 will be measured to define pharmacokinetics [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: STX107 10 mg Drug: STX107
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
Placebo Comparator: Placebo Drug: STX107
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
Active Comparator: STX107 30 mg Drug: STX107
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325740

Locations
United States, California
University of California-Los Angeles Neuropsychiatric Institute
Los Angeles, California, United States, 90024
University of California-Davis, M.I.N.D. Institute
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Denver, Children's Hospital
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University School of Medicine
Decatur, Georgia, United States, 30033
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Seaside Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01325740     History of Changes
Other Study ID Numbers: 107FX201
Study First Received: March 28, 2011
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on May 22, 2013