Phase 2
Completed N=99
Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease
Source: ClinicalTrials.gov NCT00909545 ↗Enrolled (actual)
99
Serious AEs
7.1%
Results posted
Apr 2013
Primary outcomePrimary: Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR. — 25; 19; 19; 9 participants — p=0.1383
Summary
The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR. |
25; 19; 19; 9 | 0.1383 |
| SECONDARY Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS) |
7.40; 7.44; 6.30; 5.40 | 0.9834 |
| SECONDARY Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale |
0.30; 0.76; 0.30; 0.03 | 0.2324 |
| SECONDARY Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale |
2.60; 3.20; 2.09; 1.86 | 0.4648 |
| SECONDARY Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale |
4.32; 3.49; 3.91; 3.69 | 0.579 |
| SECONDARY Efficacy: Change in Modified Hoehn & Yahr Scale |
0.27; 0.22; 0.12; 0.11 | 0.6677 |
| SECONDARY Efficacy: Change in Modified Schwab & England Independence Scale |
-5.04; -5.56; -3.69; -3.76 | 0.7111 |
| SECONDARY Efficacy: Change in Beck Depression Inventory II (BDI-II) |
-0.52; 1.99; 0.11; 1.50 | 0.0608 |
| SECONDARY Efficacy: Change in Montreal Cognitive Assessment |
0.58; 0.06; 0.11; 0.36 | 0.3533 |
| SECONDARY Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39) |
1.28; 3.47; 3.00; 3.35 | 0.2278 |
| SECONDARY Vital Signs: Change in Systolic Standing |
-4.77; -9.85; -7.75; -6.30 | — |
| SECONDARY Vital Signs: Change in Systolic Supine |
-2.45; -8.59; -6.45; -7.01 | — |
| SECONDARY Vital Signs: Change in Diastolic Standing |
-0.38; -4.20; -5.14; -4.34 | — |
| SECONDARY Vital Signs: Change in Diastolic Supine |
0.09; -2.79; -4.54; -3.63 | — |
| SECONDARY Vital Signs: Change in Pulse Standing |
-0.08; -2.98; -2.29; -1.21 | — |
| SECONDARY Vital Signs: Change in Pulse Supine |
-0.42; -0.71; -0.52; 0.18 | — |
| SECONDARY Common Adverse Events: Oedema Peripheral |
1; 4; 10; 16 | 0.1384 |
| SECONDARY Common Adverse Events: Dizziness |
7; 5; 6; 6 | 0.7735 |
| SECONDARY Common Adverse Events: Nasopharyngitis |
2; 4; 7; 4 | 0.2756 |
| SECONDARY Common Adverse Events: Headache |
3; 3; 6; 4 | 0.6049 |
| SECONDARY Common Adverse Events: Constipation |
3; 2; 3; 4 | 0.7852 |
| SECONDARY Common Adverse Events: Fatigue |
2; 1; 3; 3 | 0.8589 |
| SECONDARY Common Adverse Events: Nausea |
3; 2; 1; 2 | 0.7852 |
| SECONDARY Common Adverse Events: Upper Respiratory Tract Infection |
1; 2; 5; 0 | 0.4532 |
| SECONDARY Common Adverse Events: Depression |
2; 3; 1; 1 | 0.4402 |
| SECONDARY Common Adverse Events: Somnolence |
2; 3; 2; 0 | 0.4402 |
| SECONDARY Common Adverse Events: Insomnia |
2; 3; 1; 1 | 0.4402 |
| SECONDARY Common Adverse Events: Dyspepsia |
3; 1; 1; 1 | 0.9294 |
| SECONDARY Common Adverse Events: Diarrhoea |
2; 1; 2; 1 | 0.8589 |
| SECONDARY Common Adverse Events: Sinusitis |
3; 2; 1; 0 | 0.7852 |
| SECONDARY Common Adverse Events: Back Pain |
1; 0; 2; 3 | 0.5000 |
| SECONDARY Common Adverse Events: Hypotension |
1; 1; 2; 2 | 0.7236 |
Eligibility Criteria
Inclusion Criteria
- Subjects with early idiopathic PD. If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms.
- Be over 30 years old at the time of diagnosis of PD.
- Hoehn & Yahr stage is less than or equal to 2.5.
- Currently not receiving dopaminergic therapy and not projected to require dopaminergic therapy for at least 6 months from enrollment.
- Use of MAO-B inhibitors (rasagiline, selegiline), amantadine, or anticholinergics will be allowed. The dosage has to be stable for 3 months prior to baseline visit and throughout the duration of the study.
Exclusion Criteria
- Subjects with a diagnosis of an atypical Parkinsonism
- Subjects unwilling or unable to give informed consent
- Use of CoQ10 at a dosage >600mg daily or use of creatine >5 grams daily within the 60 days prior to randomization
- Exposure to dopaminergic PD therapy within 60 days prior to enrollment or for 3 months or more at any point in the past
- History of clinically significant orthostatic hypotension or 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 15 at screening
- History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to enrollment
- Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to enrollment
- Lactating women or women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative serum pregnancy test at screening
- Participation in other investigational drug trials within 30 days prior to screening
- History of brain surgery for PD
Data sourced from ClinicalTrials.gov (NCT00909545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.