Trials / Completed
CompletedNCT02582866
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- UCB Biopharma S.P.R.L. · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 \[NCT01465997\]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lacosamide | * Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2015-10-21
- Last updated
- 2023-06-06
- Results posted
- 2021-01-22
Locations
46 sites across 15 countries: Bulgaria, Finland, France, Germany, Japan, Latvia, Mexico, Philippines, Poland, Romania, Russia, South Korea, Sweden, Switzerland, Ukraine
Source: ClinicalTrials.gov record NCT02582866. Inclusion in this directory is not an endorsement.