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 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II|
- Tolerability of Isradipine Based on the Number of Participants That Complete the Study [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number of Participants That Tolerated Each Dose of Isradipine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Tolerability= maximum tolerated dose
- Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.
HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent
- Number of Participants That Completed the Study at Each Dose Level of Isradipine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Change in Motor UPDRS Scores: Baseline vs. Final Visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Baseline visit = Week 0 Final visit = Week 12
Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:
Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.
The higher the UPDRS score, the greater the disability from PD.
The range for scores for Section III is 0 to 108.
- Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine [ Time Frame: 1 year ] [ Designated as safety issue: No ]Mean Plasma Concentration (+/- SD ng/mL)
|Study Start Date:||April 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Drug: Dynacirc CR (Isradipine)
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.
Other Name: Isradipine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753636
|United States, Illinois|
|710 N. Lake Shore Dr.|
|Chicago, Illinois, United States, 60610|
|Principal Investigator:||Tanya Simuni, M.D.||Northwestern University|