A Study of E2007 In Patients With Parkinson's Disease
- Registration Number
- NCT00427011
- Lead Sponsor
- Eisai Inc.
- Brief Summary
Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 \[Visit 2\] through Week 12 \[Visit 7\]) followed by the Maintenance Phase (from Week 12 \[Visit 7\] to end of study).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 E2007 -
- Primary Outcome Measures
Name Time Method Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 The UPDRS is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
Trial Locations
- Locations (9)
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸St. Petersburg, Florida, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Pacific Neuroscience Medical Group
🇺🇸Oxnard, California, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Clinical Trials Incorporated
🇺🇸Little Rock, Arkansas, United States
Charlotte Neurological Services
🇺🇸Port Charlotte, Florida, United States
Agape Medical Research Center, Inc.
🇺🇸Lubbock, Texas, United States