Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Eisai Limited |
---|---|
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00286897 |
Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications.
During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: E2007 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations |
Enrollment: | 702 |
Study Start Date: | February 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Study Director: | Alessia Nicotra, MD, PhD, DIC | Eisai Limited |
Study ID Numbers: | E2007-E044-301 |
Study First Received: | February 3, 2006 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00286897 History of Changes |
Health Authority: | European Union: European Medicines Agency |
Levodopa Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |