Trials / Withdrawn
WithdrawnNCT00451633
The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double blind, placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design. Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will be escalated to 4 mg E2007 o.d. after three weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2007 |
Timeline
- Start date
- 2007-03-01
- First posted
- 2007-03-23
- Last updated
- 2013-10-31
Locations
5 sites across 2 countries: Germany, Italy
Source: ClinicalTrials.gov record NCT00451633. Inclusion in this directory is not an endorsement.