Pilot Study of Safety and Efficacy of Spheramine

This study has been terminated.
(Study was completed, only life long extended follow-up phase was discontinued after 12 years)
Sponsor:
Collaborator:
Titan Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00761436
First received: September 26, 2008
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

Tolerability and Efficacy of Spheramine will be evaluated after operative implantation (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease


Condition Intervention Phase
Parkinson's Disease
Biological: Spheramine (BAY86-5280)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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. [ Time 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Involuntary Movements, time Motor Tests [ Time Frame: Performed during defined "off" and best "on" states ] [ Designated as safety issue: No ]
  • Motor Fluctuation and Percent OFF Time Evaluation [ Time Frame: Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary ] [ Designated as safety issue: No ]
  • Quality of Life and Physician's and Patients Global Evaluations [ Time Frame: Every visit until year 5 ] [ Designated as safety issue: No ]
  • Neuropsychological Evaluations [ Time Frame: Will occur pre-operatively and at 3, 12 and 24 months post-operatively ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2000
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: Spheramine (BAY86-5280)
Stereotactic Intrastriatal Implantation

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease (PD). As defined by:

    • presence of bradykinesia and either rest tremor or rigidity
    • history of asymmetry of PD signs
    • history of progression of PD signs, and
    • no other suspected cause of PD signs
  • Patient is between 40 and 70 years of age, inclusive
  • Patient is L-dopa-sensitive and has unequivocal clinical "off" periods as documented by home diary, completed on 4 consecutive days with an average of 1.5 hours/day in the clinically "off" state
  • Patient is Hoehn & Yahr stage III or higher in the practically defined "off" phase
  • All other medical problems are stable or under control and are not contraindications to general anesthesia or stereotactic neurosurgery
  • Patient's brain magnetic imaging resonance (MRI) shows no abnormality that would contraindicate Spheramine implantation
  • Patient does not have a major psychiatric problem or dementia
  • Patient must give written informed consent to participate in this study
  • Patient must be on a stable dose of antiparkinsonian medication for at least 1 month prior to completion of the home diary assessment and the baseline UPDRS assessments
  • If the patient is a woman of childbearing potential, she must not be nursing or pregnant and must use an adequate form of birth control for the duration of the study deemed appropriate by the investigator such as oral contraceptives, IUD, or condoms
  • Patient must be living with or in close constant contact with a person who can contribute information as to the patient's condition before and after implant and provide assistance, if necessary

Exclusion Criteria:

  • Patients with atypical Parkinson's disease (e.g. parkinsonian "plus" syndrome, secondary Parkinsonian syndrome)
  • Patients exhibiting only a tremor-based symptomatology
  • Patients exhibiting very severe dyskinesias (lasting more than 2 hour/day) exacerbated by L-dopa, evaluated as 4/4 on the dyskinesia scale (violent dyskinesias, incompatible with any normal motor task)
  • Women of childbearing potential without contraception
  • Patients who are non-cooperative or incapable of completing self-evaluation scales or diaries
  • Patients presenting with known pharmacologic immunosuppression related to chemotherapeutic treatment for malignancy, autoimmune disease, allografts or other medical conditions associated with immunosuppression
  • Patient's cardiovascular, pulmonary, renal and hematological state contraindicates use of general anesthesia
  • Evidence of abnormal coagulation including PT > 13 sec, PT > 35 sec or platelets < 5 ml
  • Patients having had previous stereotactic brain surgery
  • Patients treated by apomorphine pump
  • Patients with significant cognitive impairment, untreated or treatment resistant depression, psychosis, hallucinations or delusions that would prevent their effective participation in the study
  • Patients who have participated in another experimental drug or device trial in the past 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761436

Locations
United States, Georgia
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Bayer
Titan Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00761436     History of Changes
Other Study ID Numbers: 91677, 311361
Study First Received: September 26, 2008
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 16, 2014