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NCT00216255 · ClinicalTrials.gov registry record · Phase 2
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
A Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00216255: Completed Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT00216255 is a Phase 2 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216255, a Phase 2 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.
Primary Outcome
Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore
Interventions
- DRUG Placebo
- DRUG Pagoclone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2005-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00216255 record still lists
NCT00216255 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00216255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00216255 about?
NCT00216255 is a clinical study titled "EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study". The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.
What is the current status of trial NCT00216255?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2005-04. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00216255?
The interventions under investigation include: Placebo (DRUG), Pagoclone (DRUG).
Who is sponsoring clinical trial NCT00216255?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00216255's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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