Back to resultsA Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
Primary Purpose
Fragile X Syndrome
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
STX107
Sponsored by
About this trial
This is an interventional treatment trial for Fragile X Syndrome
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. 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
Sites / Locations
- University of California-Los Angeles Neuropsychiatric Institute
- University of California-Davis, M.I.N.D. Institute
- University of Colorado Denver, Children's Hospital
- Emory University School of Medicine
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
STX107 10 mg
Placebo
STX107 30 mg
Arm Description
Outcomes
Primary Outcome Measures
Adverse events will be monitored for tolerability
physical exam, laboratories, collection of adverse events
Secondary Outcome Measures
Blood levels of STX107 will be measured to define pharmacokinetics
Full Information
NCT ID
NCT01325740
First Posted
March 28, 2011
Last Updated
December 19, 2012
Sponsor
Seaside Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01325740
Brief Title
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Suspended
Why Stopped
pending further evaluation
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seaside Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fragile X Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STX107 10 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
STX107 30 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
STX107
Intervention Description
STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
Primary Outcome Measure Information:
Title
Adverse events will be monitored for tolerability
Description
physical exam, laboratories, collection of adverse events
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Blood levels of STX107 will be measured to define pharmacokinetics
Time Frame
1 day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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. 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
Facility Information:
Facility Name
University of California-Los Angeles Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California-Davis, M.I.N.D. Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Denver, Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University School of Medicine
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome
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