Parkinson's Disease Isradipine Safety Study

This study has been completed.
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier:
NCT00753636
First received: September 13, 2008
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: January 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Drug: Dynacirc CR (Isradipine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
35 Screened

Reporting Groups
  Description
Isradipine 20mg, 15mg, 10mg or 5 mg No text entered.

Participant Flow:   Overall Study
    Isradipine 20mg, 15mg, 10mg or 5 mg  
STARTED     31  
COMPLETED     25  
NOT COMPLETED     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Isradipine 20mg, 15mg, 10mg or 5 mg No text entered.

Baseline Measures
    Isradipine 20mg, 15mg, 10mg or 5 mg  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  58.87  ± 8.23  
Gender  
[units: participants]
 
Female     13  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
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1.  Primary:   Tolerability of Isradipine Based on the Number of Participants That Complete the Study   [ Time Frame: 1 year ]

2.  Secondary:   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 ]

3.  Secondary:   Number of Participants That Tolerated Each Dose of Isradipine   [ Time Frame: 1 year ]

4.  Secondary:   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 ]

5.  Secondary:   Number of Participants That Completed the Study at Each Dose Level of Isradipine   [ Time Frame: 1 year ]

6.  Secondary:   Change in Motor UPDRS Scores: Baseline vs. Final Visit   [ Time Frame: 12 weeks ]

7.  Secondary:   Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Tanya Simuni, MD
Organization: Northwestern University
phone: 312-503-2970
e-mail: tsimuni@nmff.org


No publications provided


Responsible Party: Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier: NCT00753636     History of Changes
Other Study ID Numbers: Isradipine II
Study First Received: September 13, 2008
Results First Received: January 13, 2011
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board