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NCT01653262 · ClinicalTrials.gov registry record · Phase 3
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
NCT01653262: Completed Phase 3 study, sponsored by UCB Pharma.
NCT01653262 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 29 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653262, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
Study Summary
Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.
Primary Outcome
Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc. The Investigator completed the assessment by answering the following: "Has there been a clinically meaningful reduction of nonpsychotic behavioral side effects since the start of BRV?" \- Yes/No
Interventions
- DRUG Brivaracetam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT01653262 record still lists
NCT01653262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Brivaracetam is the first listed.
NCT01653262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01653262 about?
NCT01653262 is a clinical study titled "Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)". Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.
What is the current status of trial NCT01653262?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2012-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01653262?
The interventions under investigation include: Brivaracetam (DRUG).
Who is sponsoring clinical trial NCT01653262?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01653262's enrollment target sits among peer trials
29 1933rd of 2000 higher than 66 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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