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Terminated Phase 3 Interventional

An Open Label Extension Study in Subjects With Fragile X Syndrome

ClinicalTrials.gov ID: NCT01555333

Public ClinicalTrials.gov record NCT01555333. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 3:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subject With Fragile X Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen).

Study identification

NCT ID
NCT01555333
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Seaside Therapeutics, Inc.
Industry
Enrollment
357 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
5 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2011 (Type not available)
Primary completion
Jul 2013 (Actual)
Completion
Jul 2013 (Actual)
Last update posted
Jul 31, 2013

2011 – 2013

United States locations

U.S. sites
23
U.S. states
18
U.S. cities
23
Facility City State ZIP Site status
Seaside Therapeutics Site #16 Phoenix Arizona 85006 —
Seaside Therapeutics Site #07 Long Beach California 90806 —
Seaside Therapeutics Site #10 Sacramento California 95817 —
Seaside Therapeutics Site #17 Aurora Colorado 80045 —
Seaside Therapeutics Site #01 Miami Florida 33136 —
Seaside Therapeutics Site #14 Orange City Florida 32763 —
Seaside Therapeutics Site #20 Decatur Georgia 30033 —
Seaside Therapeutics Site #02 Chicago Illinois 60612 —
Seaside Therapeutics Site #23 Kansas City Kansas 66160 —
Seaside Therapeutics Site #12 Baltimore Maryland 21205 —
Seaside Therapeutics Site #08 Worcester Massachusetts 01605 —
Seaside Therapeutics Site #03 Columbia Missouri 65211 —
Seaside Therapeutics Site #22 New York New York 10029 —
Seaside Therapeutics Site #04 Staten Island New York 10314 —
Seaside Therapeutics Site #24 Chapel Hill North Carolina 27514 —
Seaside Therapeutics Site #21 Durham North Carolina 27710 —
Seaside Therapeutics Site #05 Akron Ohio 44308 —
Seaside Therapeutics Site #15 Oklahoma City Oklahoma 73117 —
Seaside Therapeutics Site #11 Media Pennsylvania 19063 —
Seaside Therapeutics Site #19 Nashville Tennessee 37212 —
Seaside Therapeutics Site #25 Houston Texas 77090 —
Seaside Therapeutics Site #18 San Antonio Texas 78258 —
Seaside Therapeutics Site #13 Seattle Washington 98121 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01555333, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2013 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01555333 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →