Trials / Terminated
TerminatedNCT01634360
Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations
A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With "Wearing Off" Motor Fluctuations and "on" Period Dyskinesias
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Perampanel | 1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2012-07-06
- Last updated
- 2014-07-09
- Results posted
- 2013-02-05
Source: ClinicalTrials.gov record NCT01634360. Inclusion in this directory is not an endorsement.