Trial Outcomes & Findings for Parkinson's Disease Isradipine Safety Study (NCT NCT00753636)
NCT ID: NCT00753636
Last Updated: 2021-11-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
1 year
Results posted on
2021-11-15
Participant Flow
35 Screened
Participant milestones
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parkinson's Disease Isradipine Safety Study
Baseline characteristics by cohort
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Age, Continuous
|
58.87 years
STANDARD_DEVIATION 8.23 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Tolerability of Isradipine Based on the Number of Participants That Complete the Study
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
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
|
16 Participants
|
SECONDARY outcome
Timeframe: 1 yearTolerability= maximum tolerated dose
Outcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Number of Participants That Tolerated Each Dose of Isradipine
20mg
|
16 Participants
|
|
Number of Participants That Tolerated Each Dose of Isradipine
15mg
|
5 Participants
|
|
Number of Participants That Tolerated Each Dose of Isradipine
10mg
|
6 Participants
|
|
Number of Participants That Tolerated Each Dose of Isradipine
5mg
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearAt 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
Outcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN+ 20mg
|
2 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN+ 15mg
|
3 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN+ 10 mg
|
1 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN+ 5mg
|
0 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN- 20mg
|
14 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN- 15mg
|
2 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN- 10mg
|
5 Participants
|
|
Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent
HTN- 5mg
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Number of Participants That Completed the Study at Each Dose Level of Isradipine
15mg
|
4 Participants
|
|
Number of Participants That Completed the Study at Each Dose Level of Isradipine
10mg
|
4 Participants
|
|
Number of Participants That Completed the Study at Each Dose Level of Isradipine
20mg
|
16 Participants
|
|
Number of Participants That Completed the Study at Each Dose Level of Isradipine
5mg
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksBaseline 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.
Outcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Change in Motor UPDRS Scores: Baseline vs. Final Visit
Baseline
|
7.61 UPDRS Part III Score
Standard Deviation 3.01
|
|
Change in Motor UPDRS Scores: Baseline vs. Final Visit
Final
|
7.08 UPDRS Part III Score
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: 1 yearMean Plasma Concentration (+/- SD ng/mL)
Outcome measures
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 Participants
|
|---|---|
|
Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine
20 mg
|
2.48 ng/mL
Standard Deviation 1.16
|
|
Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine
15 mg
|
2.53 ng/mL
Standard Deviation 1.33
|
|
Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine
10 mg
|
1.53 ng/mL
Standard Deviation 0.72
|
|
Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine
5 mg
|
0.68 ng/mL
Standard Deviation 0.38
|
Adverse Events
Isradipine 20mg, 15mg, 10mg or 5 mg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Isradipine 20mg, 15mg, 10mg or 5 mg
n=31 participants at risk
A group is defined by the highest dose received by the subject. Subjects are started at 5mg dose, and may end at the highest dose of 20mg, depending on how they tolerate the drug. Thus, assignment to a group is not randomized but relies on the last/highest dose received.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Leg Edema
|
54.8%
17/31 • Number of events 17
|
|
General disorders
Fatigue
|
29.0%
9/31 • Number of events 9
|
|
General disorders
Dizziness
|
32.3%
10/31 • Number of events 10
|
|
General disorders
Headache
|
16.1%
5/31 • Number of events 5
|
|
General disorders
Nausea
|
16.1%
5/31 • Number of events 5
|
|
General disorders
Cough
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Soar Throat
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Sinuses
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.5%
2/31 • Number of events 2
|
|
Reproductive system and breast disorders
Erectile/sexual Dysfunction
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Cold
|
6.5%
2/31 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place