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NCT01706523 · ClinicalTrials.gov registry record · Phase 3

Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

A Phase 3 study, sponsored by Seaside Therapeutics.

Terminated
Registry status
Phase 3
Development phase
165
Enrollment target

NCT01706523: Clinical Trial Phase 3 study, sponsored by Seaside Therapeutics.

NCT01706523 is a Phase 3 study that was terminated before completion, run by Seaside Therapeutics. The registered enrollment target is 165 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01706523, a Phase 3 study, was terminated before completion, sponsored by Seaside Therapeutics.

TERMINATED
Registry status
Phase 3
Development phase
165 participants
Enrollment target

Study Summary

This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

Primary Outcome

Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments

Interventions

  • DRUG STX209 (arbaclofen)

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2011-11
Est. Completion 2013-07
Phase Phase 3
Seaside Therapeutics

12 total trials

Why NCT01706523 stopped before completion

NCT01706523 is an interventional study that assigns participants to a tested intervention. The registered 165 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 (79% lower).

The record links to 0 conditions, and to 1 intervention - of which STX209 (arbaclofen) is the first listed.

NCT01706523 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01706523 about?

NCT01706523 is a clinical study titled "Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders". This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

What is the current status of trial NCT01706523?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2011-11. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01706523?

The interventions under investigation include: STX209 (arbaclofen) (DRUG).

Who is sponsoring clinical trial NCT01706523?

This trial is sponsored by Seaside Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01706523's enrollment target sits among peer trials

165 1465th of 2000 higher than 531 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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Source: ClinicalTrials.gov NCT01706523, the US trial registry maintained by the National Library of Medicine. NCT01706523 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.