stop_circleTerminated/Withdrawn
Parkinson''s Disease
Bayer Identifier:
91677
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Pilot Study of Safety and Efficacy of Spheramine
Trial purpose
Tolerability and Efficacy of Spheramine will be evaluated after operative implantation (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease
Key Participants Requirements
Sex
BothAge
40 - 70 YearsTrial summary
Enrollment Goal
6Trial Dates
February 2000 - May 2012Phase
Phase 2Could I Receive a placebo
NoProducts
Spheramine (BAY86-5280)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Atlanta, 30329, United States |
Primary Outcome
- The primary outcome measure for evaluating efficacy will be the motor subscore of the Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) in the practically defined "off" state. During the Screening and at Baseline Evaluations.date_rangeTime Frame:Evaluations, and at approximately 1, 3, 6, 9, 12, 15, 18 and 24 months post-implantation and annually thereafter, the patients Parkinson's symptomatology will be evaluated both on their baseline drug therapy and in the practically defined "off" period.enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Involuntary Movements, time Motor Testsdate_rangeTime Frame:Performed during defined "off" and best "on" statesenhanced_encryptionnoSafety Issue:
- Motor Fluctuation and Percent OFF Time Evaluationdate_rangeTime Frame:Daily "on" phases, "off" phases and hours of sleep per day, using Home Diaryenhanced_encryptionnoSafety Issue:
- Quality of Life and Physician's and Patients Global Evaluationsdate_rangeTime Frame:Every visit until year 5enhanced_encryptionnoSafety Issue:
- Neuropsychological Evaluationsdate_rangeTime Frame:Will occur pre-operatively and at 3, 12 and 24 months post-operativelyenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1