isradipine and Idiopathic Parkinson Disease

isradipine has been researched along with Idiopathic Parkinson Disease in 20 studies

Isradipine: A potent antagonist of CALCIUM CHANNELS that is highly selective for VASCULAR SMOOTH MUSCLE. It is effective in the treatment of chronic stable angina pectoris, hypertension, and congestive cardiac failure.

Research

Studies (20)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Adjusted Mean Change in Adjusted UPDRS Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Ambulatory Capacity

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in BDI Total Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Diastolic BP, Seated

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in H/Y Stage

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in LED

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in LED Cumulative

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Levodopa

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Levodopa Cumulative

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in MDS-UPDRS mEDL

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in MDS-UPDRS nmEDL

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in MoCA Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Modified Rankin Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in PDQ39 Total Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in SE/ADL

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Systolic BP, Seated

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in UPDRS Part II

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in UPDRS Part III OFF

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in UPDRS Part IV

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in UPDRS PIGD Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Adjusted Mean Change in UPDRS Score to 1 Year

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD. (NCT02168842)
Timeframe: Baseline to 12 months of treatment

Adjusted Mean Change in UPDRS Tremor Score

Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Risk of Need for Antiparkinsonian Therapy

Number of participants with need for Antiparkinsonian Therapy. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Risk of Need for Dyskinesia

Number of participants with need for Dyskinesia Therapy. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Risk of Need for Fluctuations

Number of participants with need for Fluctuations Therapy. (NCT02168842)
Timeframe: Baseline to 36 months of treatment

Common Adverse Events: Back Pain

Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Constipation

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Depression

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Diarrhoea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dizziness

Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Dyspepsia

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Fatigue

General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Headache

Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Hypotension

Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Insomnia

Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nasopharyngitis

Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Nausea

Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Oedema Peripheral

General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Sinusitis

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Somnolence

Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Common Adverse Events: Upper Respiratory Tract Infection

Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Beck Depression Inventory II (BDI-II)

The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Hoehn & Yahr Scale

The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Modified Schwab & England Independence Scale

The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability). (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Montreal Cognitive Assessment

The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale

The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)

The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)

Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.

Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group. (NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Diastolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Pulse Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Standing

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Vital Signs: Change in Systolic Supine

(NCT00909545)
Timeframe: Baseline to 12 months or the time to require dopaminergic therapy

Reviews

3 reviews available for isradipine and Idiopathic Parkinson Disease

Trials

6 trials available for isradipine and Idiopathic Parkinson Disease

Other Studies

11 other studies available for isradipine and Idiopathic Parkinson Disease