The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
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.