|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Eisai Limited |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00360412 |
Purpose
Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study.
Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).
A home diary will be completed in which patients rate themselves as either:
These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: E2007 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Centre, Open Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations |
| Estimated Enrollment: | 1400 |
| Study Start Date: | October 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients with idiopathic PD who have fulfilled the entry criteria to either E2007-E044-301 or E2007-A001-302 and have completed that study up to and including the final efficacy visit. Patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy. Patients with SAEs which are ongoing or possibly or probably related to the study drug, will not be eligible for this study. Patients with ongoing adverse events categorized as severe and thought to be related to E2007 should not be entered. Patients with mild or moderate adverse events thought to be related to E2007 can be entered to the study if the investigator considers it safe.
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00360412 History of Changes |
| Other Study ID Numbers: | E2007-G000-303 |
| Study First Received: | August 2, 2006 |
| Last Updated: | May 7, 2008 |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |