Pilot Study of Safety and Efficacy of Spheramine

NCT00761436 | Terminated Phase 2

• 2 other identifiers: 91677311361
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson''s Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (4)

• Involuntary Movements, time Motor Tests

  Performed during defined "off" and best "on" states

• Motor Fluctuation and Percent OFF Time Evaluation

  Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary

• Quality of Life and Physician's and Patients Global Evaluations

  Every visit until year 5

• Neuropsychological Evaluations

  Will occur pre-operatively and at 3, 12 and 24 months post-operatively

Study Arms (1)

Arm 1

EXPERIMENTAL

Biological: Spheramine (BAY86-5280)

Interventions

Spheramine (BAY86-5280) BIOLOGICAL

Stereotactic Intrastriatal Implantation

Arm 1

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Titan Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Atlanta, Georgia, 30329, United States

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 29, 2008
• Study Start: February 29, 2000
• Primary Completion: May 14, 2012
• Study Completion: May 14, 2012
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)