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NCT02408549 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 239
- Enrollment target
NCT02408549: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT02408549 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 239 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408549, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 239 participants
- Enrollment target
Study Summary
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.
Primary Outcome
AEs were considered treatment-emergent if event had onset on or after date of first study medication dose in EP0012 and within 30 days following last study medication dose or events whose intensity worsened on or after date of first study medication dose and within 30 days following date of last study medication administration. Adverse Events were reported spontaneously by the participant and/or caregiver or observed by the investigator.
Interventions
- DRUG Lacosamide Tablet
- DRUG Lacosamide Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2015-08-03 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 3 |
What the finished NCT02408549 record still lists
NCT02408549 is an interventional study that assigns participants to a tested intervention. The registered 239 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 (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Lacosamide Tablet is the first listed.
NCT02408549 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02408549 about?
NCT02408549 is a clinical study titled "Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures". Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT0240852...
What is the current status of trial NCT02408549?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2015-08-03. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT02408549?
The interventions under investigation include: Lacosamide Tablet (DRUG), Lacosamide Oral Solution (DRUG).
Who is sponsoring clinical trial NCT02408549?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02408549's enrollment target sits among peer trials
239 1291st of 2000 higher than 710 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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