Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00753636 · ClinicalTrials.gov registry record · Phase 2
Parkinson's Disease Isradipine Safety Study
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00753636 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 31 participants.
The verdict
NCT00753636, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is conducted in parallel with Dr. Surmeier's work on further development of the preclinical data. The focus of his work now is to establishing the correlation between the dose that demonstrated neuroprotective effect in animal model and the dose used for clinical practice. Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended dose range. We expect 10% attrition due to hypotensive effect of the agent. Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based on the blood pressure reading.
Interventions
- DRUG Dynacirc CR (Isradipine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00753636
The ClinicalTrials.gov registry entry for NCT00753636 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dynacirc CR (Isradipine) is the first listed.
NCT00753636 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00753636 about?
NCT00753636 is a clinical study titled "Parkinson's Disease Isradipine Safety Study". The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the effi...
What is the current status of trial NCT00753636?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2008-04. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00753636?
The interventions under investigation include: Dynacirc CR (Isradipine) (DRUG).
Who is sponsoring clinical trial NCT00753636?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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.