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NCT00162981 · ClinicalTrials.gov registry record · Phase 2
Clobazam in Subjects With Lennox-Gastaut Syndrome
A Phase 2 study, sponsored by Lundbeck.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT00162981: Completed Phase 2 study, sponsored by Lundbeck.
NCT00162981 is a Phase 2 study that has completed, run by Lundbeck. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00162981, a Phase 2 study, has completed, sponsored by Lundbeck.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Primary Outcome
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Interventions
- DRUG Clobazam Low Dose
- DRUG Clobazam High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
What the finished NCT00162981 record still lists
NCT00162981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Clobazam Low Dose is the first listed.
NCT00162981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00162981 about?
NCT00162981 is a clinical study titled "Clobazam in Subjects With Lennox-Gastaut Syndrome". The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigationa...
What is the current status of trial NCT00162981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2005-10. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00162981?
The interventions under investigation include: Clobazam Low Dose (DRUG), Clobazam High Dose (DRUG).
Who is sponsoring clinical trial NCT00162981?
This trial is sponsored by Lundbeck, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00162981's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 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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