CLINICAL TRIALS PROFILE FOR ISRADIPINE
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All Clinical Trials for ISRADIPINE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00593463 ↗ | Drug Discrimination in Methadone-Maintained Humans Study 1 | Completed | University of Arkansas | Phase 1 | 2006-09-01 | This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions. |
| NCT00753636 ↗ | Parkinson's Disease Isradipine Safety Study | Completed | Northwestern Memorial Hospital | Phase 2 | 2008-04-01 | 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. |
| NCT00753636 ↗ | Parkinson's Disease Isradipine Safety Study | Completed | Northwestern University | Phase 2 | 2008-04-01 | 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. |
| NCT00909545 ↗ | Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease | Completed | Michael J. Fox Foundation for Parkinson's Research | Phase 2 | 2009-07-01 | The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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