Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00040209 · ClinicalTrials.gov registry record · Phase 2
JP-1730 to Treat Parkinson's Disease
A Phase 2 study of Parkinson Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00040209 is a Phase 2 study of Parkinson Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00040209, a Phase 2 study of Parkinson Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study. * Phase 1 - Baseline evaluation Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.) * Phase 2 - Dose Finding Phase For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.) * Phase 3 - Active Study Phase Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of th
Conditions Studied
Interventions
- DRUG JP 1730
- DRUG IV Levodopa
- DRUG IV Apomorphine
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-06 |
| Est. Completion | 2005-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040209
The ClinicalTrials.gov registry entry for NCT00040209 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, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). 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 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which JP 1730 is the first listed.
NCT00040209 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00040209 about?
NCT00040209 is a clinical study titled "JP-1730 to Treat Parkinson's Disease". This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. ...
What is the current status of trial NCT00040209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-06. Estimated completion is 2005-07.
What conditions does trial NCT00040209 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT00040209?
The interventions under investigation include: JP 1730 (DRUG), IV Levodopa (DRUG), IV Apomorphine (DRUG).
Who is sponsoring clinical trial NCT00040209?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00040209 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
RECRUITING · Phase 2
-
Pyridostigmine for the Treatment of Constipation in Parkinson Disease
RECRUITING · Phase 2
-
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
RECRUITING · Phase 2
-
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
RECRUITING · Phase 2
-
Rehabilitation of Airway Protection in Parkinson's Disease
RECRUITING · Phase 2
-
Psilocybin Therapy for Depression in Parkinson's Disease
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.