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.

Clinical Trial Conditions for Isradipine

Condition Name

Condition Name for Isradipine
Intervention	Trials
Hypertension	2
Parkinson Disease	2
Smoking Cessation	1
Drug Dependence	1

Condition MeSH

Condition MeSH for Isradipine
Intervention	Trials
Hypertension	3
Parkinson Disease	3
Depression	1
Bipolar Disorder	1

Clinical Trial Locations for Isradipine

Trials by Country

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

Trials by US State

Trials by US State for Isradipine
Location	Trials
New York	4
Pennsylvania	3
Massachusetts	3
Illinois	3
Texas	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
National Institute on Drug Abuse (NIDA)	2
Northwestern University	2
Michael J. Fox Foundation for Parkinson's Research	2

Sponsor Type

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

Isradipine: Clinical Trials, Market Analysis, and Projections

Introduction to Isradipine

Isradipine is a calcium channel blocker primarily used to treat high blood pressure. It has also been explored for its potential neuroprotective effects in Parkinson's disease (PD). Here, we will delve into the clinical trials, market analysis, and projections for isradipine.

Clinical Trials Update

STEADY-PD Trials

The most significant clinical trials involving isradipine for Parkinson's disease are the STEADY-PD trials. These trials aimed to assess the safety, tolerability, and efficacy of isradipine as a potential disease-modifying agent in early PD.

Phase II Trial

The Phase II STEADY-PD trial focused on determining the highest safe and effective dose of isradipine for PD patients. The study involved 99 patients with early PD, who were assigned to one of four treatment groups: 5 mg, 10 mg, 20 mg of isradipine, or a placebo. The trial found that the 10 mg daily dose was the maximally tolerable dosage, with common adverse events including peripheral edema and dizziness. However, there was no significant difference in efficacy between the treatment arms and the placebo group[4].

Phase III Trial

The Phase III STEADY-PD III trial was a 36-month placebo-controlled study that failed to show that isradipine significantly improved Unified Parkinson Disease Rating Scale (UPDRS) scores. This indicates that isradipine did not significantly slow or stop the clinical progression of early Parkinson's disease[1][3].

Market Analysis

Current Market Size and Trends

The global isradipine market, while not as extensively detailed as other calcium channel blockers like nifedipine, is part of a broader market for hypertension treatments. The market for isradipine is influenced by its primary use in treating high blood pressure.

• Global Market: The global market for isradipine is expected to grow, albeit at a slower rate compared to other calcium channel blockers. The market size was valued at a certain amount in 2018 and is projected to expand at a specific CAGR from 2019 to 2025[2].

Consumption by Application

Isradipine's primary application is in the treatment of hypertension. The market analysis shows that the consumption of isradipine is largely driven by its use in managing high blood pressure.

• Hypertension Treatment: The demand for isradipine is closely tied to the prevalence of hypertension. With increasing rates of chronic illnesses such as high blood pressure, the demand for calcium channel blockers like isradipine is expected to rise[2].

Regional Market Analysis

The market for isradipine varies by region, with different factors influencing demand.

• North America: This region is a significant market for isradipine, driven by high rates of hypertension and other cardiovascular diseases. The increase in obesity and related health issues in the U.S. contributes to the demand for hypertension medications[5].
• Asia-Pacific: This region is expected to see growth in the demand for isradipine due to increasing healthcare access and infrastructure development. Initiatives like India's National Health Policy aim to reduce cardiovascular deaths, which could increase the market demand for hypertension treatments[5].

Market Projections

Forecast to 2025 and Beyond

The market for isradipine is expected to grow, though at a moderate pace.

• Global and Chinese Market: The global and Chinese isradipine market is projected to expand from 2019 to 2025. The forecast includes detailed analyses of capacity, production, and production value, as well as supply and consumption trends[2].

Economic Impact and Industry Dynamics

The market for isradipine is influenced by broader economic and industry trends.

• Macroeconomic Environment: Global and Chinese macroeconomic conditions play a significant role in the isradipine market. Economic growth, healthcare policies, and demographic changes affect the demand for hypertension treatments[2].
• Industry Challenges and Opportunities: The isradipine market faces challenges such as competition from other calcium channel blockers and opportunities like increasing healthcare access in developing regions[2].

Key Takeaways

• Clinical Trials: The STEADY-PD trials showed that while isradipine is safe and tolerable in PD patients, it did not significantly slow or stop the progression of Parkinson's disease.
• Market Size and Trends: The global isradipine market is growing, driven by its use in treating hypertension, with significant demand in regions like North America and Asia-Pacific.
• Regional Analysis: The market is influenced by regional health trends, healthcare infrastructure, and economic conditions.
• Projections: The market is expected to expand from 2019 to 2025, with detailed forecasts for capacity, production, and consumption.

FAQs

What was the outcome of the STEADY-PD III clinical trial for isradipine in Parkinson's disease?

The STEADY-PD III trial failed to show that isradipine significantly improved UPDRS scores, indicating it did not slow or stop the clinical progression of early Parkinson's disease[1].

What is the primary use of isradipine?

Isradipine is primarily used to treat high blood pressure (hypertension)[4].

Which regions are expected to see significant growth in the demand for isradipine?

North America and the Asia-Pacific region are expected to see significant growth in the demand for isradipine due to increasing healthcare access and prevalence of hypertension[2][5].

What are the common adverse events associated with isradipine in PD patients?

The common adverse events associated with isradipine in PD patients include peripheral edema and dizziness[4].

Is isradipine effective in slowing the progression of Parkinson's disease?

No, the clinical trials have shown that isradipine does not significantly slow or stop the progression of Parkinson's disease[1][3].

Sources

1. Parkinson's UK: "Blood pressure drug fails in phase 3 Parkinson's trial" - May 8, 2019.
2. Prof-Research: "Isradipine Market Size, Share, Trend and Forecast to 2025".
3. ResearchGate: "A Clinical Trial of Isradipine: What Went Wrong?" - October 22, 2024.
4. Michael J. Fox Foundation: "Phase II Study of Isradipine as a Disease-modifying Agent in Early Parkinson’s Disease".
5. StraitsResearch: "Nifedipine Market Size, Share, Trends, Forecast Report 2032" - February 13, 2024.

Last updated: 2025-01-01