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NCT00139594 · ClinicalTrials.gov registry record · Phase 4
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
A Phase 4 study of Bipolar Disorder, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT00139594: Completed Phase 4 study of Bipolar Disorder, sponsored by Novartis.
NCT00139594 is a Phase 4 study of Bipolar Disorder that has completed, run by Novartis. The registered enrollment target is 181 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00139594, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
Conditions Studied
Interventions
- DRUG licarbazepine
Study Locations (20)
Other
- Novartis Investigational Site - Vienna
- Novartis Investigational Site - Greater Sudbury
- Novartis Investigational Site - Kelowna
- Novartis Investigational Site - London
- Novartis Investigational Site - Montreal
- Novartis Investigator Site - Vancouver
- Novartis Investigational Site - Bogotá
Texas
- Novartis Investigational Site - Bellaire
- Novartis Investigational Site - Dallas
- Novartis Investigational Site - Verdun
Washington
- Novartis Investigational Site - Bellevue
- Novartis Investigational Site - Kirkland
California
- Investigational site - La Palma
Kansas
- Novartis Investigational Site - Kansas City
Louisiana
- Novartis Investigational Site - Shreveport
Massachusetts
- Novartis Investigational Site - Somerville
Michigan
- Novartis Investigational Site - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-07 |
| Phase | Phase 4 |
What the finished NCT00139594 record still lists
NCT00139594 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 1 intervention - of which licarbazepine is the first listed.
NCT00139594 names 20 study sites across 11 states, led by Other, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT00139594 about?
NCT00139594 is a clinical study titled "Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder". This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
What is the current status of trial NCT00139594?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 181 participants. The study started on 2004-12. Estimated completion is 2007-07.
What conditions does trial NCT00139594 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00139594?
The interventions under investigation include: licarbazepine (DRUG).
Who is sponsoring clinical trial NCT00139594?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00139594 being conducted?
This trial has 20 study locations across California, Kansas, Louisiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00139594's enrollment target sits among peer trials
181 40th of 162 higher than 123 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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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