Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00006077 · ClinicalTrials.gov registry record · Phase 2
Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease
A Phase 2 study of Parkinson's Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00006077 is a Phase 2 study of Parkinson's Disease that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 50 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00006077, a Phase 2 study of Parkinson's Disease, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from entering nerve cells. Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study. Candidates will have a complete medical history and physical examination with a detailed neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will have blood and urine tests and an electrocardiogram (EKG) and will take a written test for evaluation of depression. Patients enrolled in the study will, if possible, stop taking all antiparkinson medications except levodopa (Sinemet) for one month before the study begins and through its duration. For the first 1 to 3 days, patients will undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3) unacceptable side effects occur, or 4) the maximum study dose is reached. When the patient's optimal dose is determined, treatment will begin. Patients will take three pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a week for up to 5 weeks, in addition to their regular levodopa medication. All participants will receive placebo at some point in the study; some patients will receive only placebo throughout the entire 5 weeks. On treatment days, patients will have a brief medical examination before receiving the drug and will then be monitored
Conditions Studied
Interventions
- DRUG NS2330
- DRUG Levodopa and Domperidone
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2000-08 |
| Est. Completion | 2003-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006077
The ClinicalTrials.gov registry entry for NCT00006077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (92% 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's Disease appearing as the primary indexed condition, and to 2 interventions - of which NS2330 is the first listed.
NCT00006077 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00006077 about?
NCT00006077 is a clinical study titled "Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's Disease". This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from entering nerve cells. Patients b...
What is the current status of trial NCT00006077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2000-08. Estimated completion is 2003-07.
What conditions does trial NCT00006077 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT00006077?
The interventions under investigation include: NS2330 (DRUG), Levodopa and Domperidone (DRUG).
Who is sponsoring clinical trial NCT00006077?
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 NCT00006077 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's 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.
-
Ketamine for Veterans With Parkinson's Disease
RECRUITING · Phase 2
-
Imaging Depression in Parkinson's Disease
RECRUITING · Phase 2
-
Evaluation of Tau-Pathology in Sporadic and LRRK2 Parkinson's Disease
RECRUITING · Phase 2
-
Tenapanor in Synucleinopathy-Related Constipation
RECRUITING · Phase 2
-
A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease
ACTIVE NOT 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.