Trials / Completed
CompletedNCT00477295
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 583 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zonisamide | Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase. |
| DRUG | Carbamazepine | Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase. |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-12-01
- Completion
- 2011-01-01
- First posted
- 2007-05-23
- Last updated
- 2015-12-24
- Results posted
- 2013-02-08
Locations
79 sites across 18 countries: Australia, Denmark, France, Germany, Greece, Hungary, India, Italy, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT00477295. Inclusion in this directory is not an endorsement.