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

NCT ID: NCT01325740

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fragile X Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STX107 10 mg

Group Type ACTIVE_COMPARATOR

STX107

Intervention Type DRUG

STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

Placebo

Group Type PLACEBO_COMPARATOR

STX107

Intervention Type DRUG

STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

STX107 30 mg

Group Type ACTIVE_COMPARATOR

STX107

Intervention Type DRUG

STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

Interventions

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STX107

STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seaside Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California-Los Angeles Neuropsychiatric Institute

Los Angeles, California, United States

Site Status

University of California-Davis, M.I.N.D. Institute

Sacramento, California, United States

Site Status

University of Colorado Denver, Children's Hospital

Aurora, Colorado, United States

Site Status

Emory University School of Medicine

Decatur, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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107FX201

Identifier Type: -

Identifier Source: org_study_id