Parkinson DiseasePhase 2NCT00004387
Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
A Phase 2 study testing fetal nigral transplantation in people with Parkinson Disease, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- fetal nigral transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 1996to not given
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics-- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination
About this study
OBJECTIVES:
- Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
Read the detailed description
PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted into the striatum of each side.
Group B patients receive 2 separate placebo operations without fetal transplantation.
The second surgical procedure begins approximately 1 week after the first operation.
After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.
- Conditions
- Parkinson Disease
- Being tested
- fetal nigral transplantation
- Keywords
- Parkinson disease, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Parkinson Disease, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal nigral transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Masking
- Double blind
- Enrolment
- 34 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Icahn School of Medicine at Mount Sinai
- Investigators
- C. Warren Olanow, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004387
- Sponsor's protocol ID
- 199/12102
- Other IDs
- MTS-94339, MTS-GCO-94-339
- Status last verified
- Jul 2000
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00004387
- Acronym / sponsor ID
- 199/12102
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, neurologic and psychiatric disorders, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Icahn School of Medicine at Mount Sinai
- Study start
- Jan 1996
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's disease.
Detailed description
PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted into the striatum of each side.
Group B patients receive 2 separate placebo operations without fetal transplantation.
The second surgical procedure begins approximately 1 week after the first operation.
After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's disease, then patients who received placebo operation will be offered transplant surgery in the final year of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| fetal nigral transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
C. Warren Olanow study chair
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fetal nigral transplantation in people with Parkinson Disease, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Jun 2005.