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NCT01555333 · ClinicalTrials.gov registry record · Phase 3
An Open Label Extension Study in Subjects With Fragile X Syndrome
A Phase 3 study, sponsored by Seaside Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 357
- Enrollment target
NCT01555333: Clinical Trial Phase 3 study, sponsored by Seaside Therapeutics.
NCT01555333 is a Phase 3 study that was terminated before completion, run by Seaside Therapeutics. The registered enrollment target is 357 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555333, a Phase 3 study, was terminated before completion, sponsored by Seaside Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 357 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Adverse Events, Suicidality Assessment, Physical Examination, Vital Signs and Weight, Laboratory Tests: Complete Blood Count, Urinalysis, Chemistry Panel
Interventions
- DRUG arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
Why NCT01555333 stopped before completion
NCT01555333 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which arbaclofen is the first listed.
NCT01555333 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555333 about?
NCT01555333 is a clinical study titled "An Open Label Extension Study in Subjects With Fragile X Syndrome". 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).
What is the current status of trial NCT01555333?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 357 participants. The study started on 2011-11. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01555333?
The interventions under investigation include: arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01555333?
This trial is sponsored by Seaside Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01555333's enrollment target sits among peer trials
357 1023rd of 2000 higher than 977 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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