stop_circleTerminated/Withdrawn

Parkinson''s Disease

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

Both

Age

40 - 70 Years

Trial summary

Enrollment Goal
6
Trial Dates
February 2000 - May 2012
Phase
Phase 2
Could I Receive a placebo
No
Products
Spheramine (BAY86-5280)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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_encryption
    Safety Issue:
    no

Secondary Outcome

  • Involuntary Movements, time Motor Tests
    date_rangeTime Frame:
    Performed during defined "off" and best "on" states
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    Safety Issue:
    no
  • Motor Fluctuation and Percent OFF Time Evaluation
    date_rangeTime Frame:
    Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary
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    Safety Issue:
    no
  • Quality of Life and Physician's and Patients Global Evaluations
    date_rangeTime Frame:
    Every visit until year 5
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    Safety Issue:
    no
  • Neuropsychological Evaluations
    date_rangeTime Frame:
    Will occur pre-operatively and at 3, 12 and 24 months post-operatively
    enhanced_encryption
    Safety Issue:
    no

Trial design

Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy.
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1