CLINICAL TRIALS PROFILE FOR ISRADIPINE

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.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	Northwestern University Dixon Fund	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.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	The Parkinson Study Group	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.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	Northwestern University	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.

Clinical Trial Conditions for Isradipine

Condition Name

Condition Name for Isradipine
Intervention	Trials
Hypertension	2
Parkinson Disease	2
Schizoaffective Disorder	1
Bipolar Disorder	1

Condition MeSH

Condition MeSH for Isradipine
Intervention	Trials
Hypertension	3
Parkinson Disease	3
Schizophrenia	1
Psychotic Disorders	1

Clinical Trial Locations for Isradipine

Trials by Country

Trials by Country for Isradipine
Location	Trials
United States	52
Canada	4
Hungary	1
Bulgaria	1

Trials by US State

Trials by US State for Isradipine
Location	Trials
New York	4
Massachusetts	3
Illinois	3
Pennsylvania	3
Florida	2

Clinical Trial Progress for Isradipine

Clinical Trial Phase

Clinical Trial Phase for Isradipine
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Isradipine
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Terminated	1

Clinical Trial Sponsors for Isradipine

Sponsor Name

Sponsor Name for Isradipine
Sponsor	Trials
The Parkinson Study Group	2
Menarini International Operations Luxembourg SA	2
University of Arkansas	2

Sponsor Type

Sponsor Type for Isradipine
Sponsor	Trials
Other	19
NIH	3
Industry	2