Pilot Study of Safety and Efficacy of Spheramine

Bayer

Status and phase

Terminated

Phase 2

Conditions

Parkinson''s Disease

Treatments

Biological: Spheramine (BAY86-5280)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00761436

311361 (Other Identifier)

91677

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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