The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
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|ClinicalTrials.gov Identifier: NCT00286897|
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: E2007||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||702 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||August 2007|
- Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).
- Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286897
|Study Director:||Alessia Nicotra, MD, PhD, DIC||Eisai Limited|