Pilot Study of Safety and Efficacy of Spheramine

April 6, 2021 updated by: Bayer

Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Biological: Spheramine (BAY86-5280)
Stereotactic Intrastriatal Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
Involuntary Movements, time Motor Tests
Time Frame: Performed during defined "off" and best "on" states
Performed during defined "off" and best "on" states
Motor Fluctuation and Percent OFF Time Evaluation
Time Frame: Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary
Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary
Quality of Life and Physician's and Patients Global Evaluations
Time Frame: Every visit until year 5
Every visit until year 5
Neuropsychological Evaluations
Time Frame: Will occur pre-operatively and at 3, 12 and 24 months post-operatively
Will occur pre-operatively and at 3, 12 and 24 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Titan Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 29, 2000

Primary Completion (ACTUAL)

May 14, 2012

Study Completion (ACTUAL)

May 14, 2012

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

September 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91677
  • 311361 (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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