Parkinson's Disease Isradipine Safety Study

NCT00753636 | Completed Phase 2 Results DMC

• 1 other identifier: Isradipine II
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Isradipine; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Tolerability of Isradipine Based on the Number of Participants That Complete the Study

  1 year

Secondary Outcomes (6)

• Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily

  1 year

• Number of Participants That Tolerated Each Dose of Isradipine

  1 year

• Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent

  1 year

• Number of Participants That Completed the Study at Each Dose Level of Isradipine

  1 year

• Change in Motor UPDRS Scores: Baseline vs. Final Visit

  12 weeks

Study Arms (1)

Dynacirc CR (Isradipine)

EXPERIMENTAL

Dynacirc CR (Isradipine) will start at 5mg dose and increased in increments of 5mg every 2 weeks

Drug: Dynacirc CR (Isradipine)

Interventions

Dynacirc CR (Isradipine) DRUG

Dynacirc CR is given by the recommended schedule for titration. Subjects start on a 5mg dose and are increased in increments of 5mg every 2 weeks provided that the subjects do not have significant adverse events or symptomatic orthostatic hypotension.

Also known as: Isradipine

Dynacirc CR (Isradipine)

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with idiopathic Parkinson's disease age 30-75
• Hoehn and Yahr stage \<2.5
• PD duration less than 5 years
• For the subjects treated with PD medications, the regimen has to be stable for \>1 month prior to enrollment

You may not qualify if:

• Atypical Parkinsonian syndrome
• Patients with history of stable hypertension treated with other antihypertensive agents will be allowed provided that the doses of concomitant anti HTN therapy can be reduced/adjusted during the study based on the BP readings. The number of concomitant antihypertensive agents should not exceed two. The dose of concomitant antihypertensive agents has to be stable for \> 1 month
• Presence of orthostatic hypotension at the screening visit defined as \> 20 mmHg change in systolic BP and 10mm change in diastolic BP after 2 min of standing, or baseline BP \<90/60.
• Presence of other medical conditions that in the opinion of the investigator will preclude safe use of the drug.
• Presence of cognitive dysfunction as determined by MMSE score \<24
• Failure to sign the informed consent
• Inability to cooperate with the study procedures
• Presence of motor fluctuations
• History of bradycardia defined as heart rate \< 55
• Women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative urine pregnancy test at screening
• Participation in other investigational drug trials within 30 days prior to screening
• History of brain surgery for Parkinson's Disease.

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

710 N. Lake Shore Dr.

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Isradipine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Tanya Simuni, MD
• Organization: Northwestern University

tsimuni@nmff.org

312-503-2970

Study Officials

• Tanya Simuni, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 13, 2008
• First Posted: September 16, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 15, 2021
• Results First Posted: July 1, 2011

Record last verified: 2021-11

Locations

US (1)