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NCT01405508 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT01405508: Completed Phase 3 study, sponsored by UCB Pharma.
NCT01405508 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01405508, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).
Primary Outcome
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Interventions
- OTHER Placebo
- DRUG Brivaracetam tablets
- DRUG Brivaracetam bolus
- DRUG Brivaracetam infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01405508 record still lists
NCT01405508 is an interventional study that assigns participants to a tested intervention. The registered 105 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 (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01405508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01405508 about?
NCT01405508 is a clinical study titled "Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy". This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice ...
What is the current status of trial NCT01405508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2011-08. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01405508?
The interventions under investigation include: Placebo (OTHER), Brivaracetam tablets (DRUG), Brivaracetam bolus (DRUG), Brivaracetam infusion (DRUG).
Who is sponsoring clinical trial NCT01405508?
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 NCT01405508's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 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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