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NCT00009048 · ClinicalTrials.gov registry record · Phase 2
EMD 128130 for the Treatment of Parkinson's Disease
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00009048 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants.
The verdict
NCT00009048, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical messenger thought to regulate dopamine release, and thus affect Parkinson's disease symptoms. Patients with relatively advanced Parkinson's disease between 30 and 80 years of age may be eligible for this 3-phase study. * Phase 1 - Baseline Evaluation Participants will have a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. A chest X-ray and MRI or CT scan of the brain will be done if needed. In addition, an ACTH stimulation test will be done before and at the end of the study. For this test, a hormone called ACTH is injected into a vein. A small amount of blood is drawn before the injection and 30 and 60 minutes afterwards to measure levels of another hormone called cortisol. After these tests are completed, patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. * Phase 2 - Levodopa and Apomorphine Dose Finding For 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa and apomorphine (a dopamine agonist) "dose-finding" procedure. For this procedure, patients will stop taking Sinemet and instead will have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. * Phase 3 - Active Study Patients
Interventions
- DRUG IV Levodopa
- DRUG EMD 128130
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-01 |
| Est. Completion | 2003-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009048
The ClinicalTrials.gov registry entry for NCT00009048 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IV Levodopa is the first listed.
NCT00009048 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00009048 about?
NCT00009048 is a clinical study titled "EMD 128130 for the Treatment of Parkinson's Disease". This study will evaluate the effects of an experimental drug called EMD 128130 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. EMD 128130 inhibits the function of serotonin, a chemical messenger thought to regu...
What is the current status of trial NCT00009048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2001-01. Estimated completion is 2003-12.
What interventions are being tested in trial NCT00009048?
The interventions under investigation include: IV Levodopa (DRUG), EMD 128130 (DRUG).
Who is sponsoring clinical trial NCT00009048?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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