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Parkinson's Disease Isradipine Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753636
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : July 1, 2011
Last Update Posted : May 6, 2013
Sponsor:
Collaborator:
Northwestern Memorial Hospital
Information provided by (Responsible Party):
Tanya Simuni, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Intervention Drug: Dynacirc CR (Isradipine)
Enrollment 31
Recruitment Details  
Pre-assignment Details 35 Screened
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 31
Completed 25
Not Completed 6
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
  77.4%
>=65 years
7
  22.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
58.87  (8.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
13
  41.9%
Male
18
  58.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Tolerability of Isradipine Based on the Number of Participants That Complete the Study
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
25
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
16
3.Secondary Outcome
Title Number of Participants That Tolerated Each Dose of Isradipine
Hide Description Tolerability= maximum tolerated dose
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
20mg 16
15mg 5
10mg 6
5mg 4
4.Secondary Outcome
Title Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
Hide Description

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

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
HTN+ 20mg 2
HTN+ 15mg 3
HTN+ 10 mg 1
HTN+ 5mg 0
HTN- 20mg 14
HTN- 15mg 2
HTN- 10mg 5
HTN- 5mg 4
5.Secondary Outcome
Title Number of Participants That Completed the Study at Each Dose Level of Isradipine
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: Participants
20mg 16
15mg 4
10mg 4
5mg 1
6.Secondary Outcome
Title Change in Motor UPDRS Scores: Baseline vs. Final Visit
Hide Description

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.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: UPDRS Part III Score
Baseline 7.61  (3.01)
Final 7.08  (2.68)
7.Secondary Outcome
Title Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine
Hide Description Mean Plasma Concentration (+/- SD ng/mL)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: ng/mL
20 mg 2.48  (1.16)
15 mg 2.53  (1.33)
10 mg 1.53  (0.72)
5 mg 0.68  (0.38)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Isradipine 20mg, 15mg, 10mg or 5 mg
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Isradipine 20mg, 15mg, 10mg or 5 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Isradipine 20mg, 15mg, 10mg or 5 mg
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Isradipine 20mg, 15mg, 10mg or 5 mg
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
General disorders   
Fatigue *  9/31 (29.03%)  9
Dizziness *  10/31 (32.26%)  10
Headache *  5/31 (16.13%)  5
Nausea *  5/31 (16.13%)  5
Cough *  2/31 (6.45%)  2
Soar Throat *  2/31 (6.45%)  2
Sinuses *  2/31 (6.45%)  2
Cold *  2/31 (6.45%)  2
Musculoskeletal and connective tissue disorders   
Leg Edema *  17/31 (54.84%)  17
Reproductive system and breast disorders   
Erectile/sexual Dysfunction *  2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders   
Shortness of breath *  2/31 (6.45%)  2
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Tanya Simuni, MD
Organization: Northwestern University
Phone: 312-503-2970
EMail: tsimuni@nmff.org
Layout table for additonal information
Responsible Party: Tanya Simuni, Northwestern University
ClinicalTrials.gov Identifier: NCT00753636     History of Changes
Other Study ID Numbers: Isradipine II
First Submitted: September 13, 2008
First Posted: September 16, 2008
Results First Submitted: January 13, 2011
Results First Posted: July 1, 2011
Last Update Posted: May 6, 2013