Parkinson''s DiseasePhase 2NCT00761436
Pilot Study of Safety and Efficacy of Spheramine
A Phase 2 study testing Spheramine (BAY86-5280) in people with Parkinson''s Disease, run by Bayer at 1 site in United States.
Trial summary
Tolerability and Efficacy of Spheramine will be evaluated after operative implantation (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson''s Disease
- What is being tested?
- Spheramine (BAY86-5280)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2000to 14 May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Parkinson''s Disease
- Being tested
- Spheramine (BAY86-5280)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spheramine (BAY86-5280)Biological
Stereotactic Intrastriatal Implantation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: Spheramine (BAY86-5280) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Performed during defined "off" and best "on" states
Motor Fluctuation and Percent OFF Time Evaluation
Measured: Daily "on" phases, "off" phases and hours of sleep per day, using Home Diary
Quality of Life and Physician's and Patients Global Evaluations
Measured: Every visit until year 5
Neuropsychological Evaluations
Measured: Will occur pre-operatively and at 3, 12 and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study start29 Feb 2000
- Primary completion14 May 2012
- Study completion14 May 2012
Why it stopped: Study was completed, only life long extended follow-up phase was discontinued after 12 years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson''s DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Titan Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761436
- Sponsor's protocol ID
- 91677
- Other IDs
- 311361
- Status last verified
- Apr 2021
- First submitted
- 26 Sep 2008
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy.
- ClinicalTrials.gov ID
- NCT00761436
- Acronym / sponsor ID
- 91677
- Conditions
- Parkinson''s Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was completed, only life long extended follow-up phase was discontinued after 12 years
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Titan Pharmaceuticals
- Study start
- 29 Feb 2000 (actual)
- Primary completion
- 14 May 2012 (actual)
- Study completion
- 14 May 2012 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tolerability and Efficacy of Spheramine will be evaluated after operative implantation (Stereotactic Intrastriatal Implantation) in patients with advanced Parkinson's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: Spheramine (BAY86-5280) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Idiopathic Parkinson's disease (PD). As defined by:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spheramine (BAY86-5280)Stereotactic Intrastriatal Implantation | Biological | Arm 1 |
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.
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.
4 secondary outcomes
Involuntary Movements, time Motor Tests
Time frame: 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
Quality of Life and Physician's and Patients Global Evaluations
Time frame: Every visit until year 5
Neuropsychological Evaluations
Time frame: Will occur pre-operatively and at 3, 12 and 24 months post-operatively
Results and safety
The study was stopped early (reason given: Study was completed, only life long extended follow-up phase was discontinued after 12 years). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spheramine (BAY86-5280) in people with Parkinson''s Disease, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was completed, only life long extended follow-up phase was discontinued after 12 years). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.