Parkinson DiseasePhase 3NCT02168842
Efficacy of Isradipine in Early Parkinson Disease
A Phase 3 study testing Isradipine in people with Parkinson Disease, run by University of Rochester at 54 sites in 2 countries.
Trial summary
The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Isradipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Nov 2014to Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with early idiopathic PD (presence of at least two out of three cardinal manifestations of PD). If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms
- Age equal or greater than 30 years at the time of diagnosis of PD
- Hoehn and Yahr stage less than or equal to 2
- Diagnosis of PD less than 3 years.
- Currently NOT receiving dopaminergic therapy (levodopa, dopamine agonist or MAO-B inhibitors) and NOT projected to require PD symptomatic therapy for at least 3 months from the baseline visit
- Use of amantadine and/or anticholinergics will be allowed provided that the dose is stable for 8 weeks prior to the baseline visit
- If subject is taking any central nervous system acting medications (e.g., benzodiazepines, antidepressants, hypnotics) regimen must be stable for 30 days prior to the baseline visit
- Women of childbearing potential may enroll but must use a reliable measure of contraception and have a negative serum pregnancy test at the screening visit
Who cannot join
- Subjects with a diagnosis of an atypical Parkinsonism
- Subjects unwilling or unable to give informed consent
- Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for consecutive 3 months or more at any point in the past
- History of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening or baseline visit defined as greater than or equal to 20 mmHg change in systolic BP and greater than or equal to 10 mmHg change in diastolic BP from sitting position to standing after 2 minutes, or baseline sitting BP less than 90/60
- History of congestive heart failure
- Clinically significant bradycardia
Show all 20Show fewer
- Presence of 2nd or 3rd degree atrioventricular block or other significant ECG abnormalities that in the investigator's opinion would compromise participation in study
- Clinically significant abnormalities in the Screening Visit laboratory studies or ECG
- Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
- Prior exposure to isradipine or other dihydropyridine calcium channel blockers within 6 months of the baseline visit
- Subjects on greater than 2 concomitant antihypertensive medications. If a history of hypertension, then a maximum of 2 other antihypertensive agents will be allowed provided that the dosages of concomitant anti HTN therapy can be reduced/adjusted during the study based on the BP readings in consultation with the subject's primary care provider or cardiologist. Use of any concomitant calcium channel blockers will not be allowed from the baseline visit and for the duration of the study
- Use of grapefruit juice, ginkgo biloba, St. John's wort or ginseng will be prohibited starting from the screening visit and for the duration of the study (as they interfere with the metabolism of isradipine)
- Use of clarithromycin, telithromycin and erythromycin will be prohibited starting from the screening visit and for the duration of the study as the combination of clarithromycin, telithromycin or erythromycin and calcium channel blockers has been reported to be associated with increased risk of kidney and heart injury
- Presence of cognitive dysfunction defined by a Montreal Cognitive assessment (MoCA) score of less than 26 at screening
- Subjects with clinically significant depression as determined by a Beck Depression Inventory II (BDI) score greater than 15 at the screening visit
- History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
- History of use of an investigational drug within 30 days prior to the screening visit
- History of brain surgery for PD
- Allergy/sensitivity to isradipine or its matching placebo or their formulations
- Pregnant or lactating woman
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States47 sites
Albany Medical College
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30329
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston University Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29401
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43221
Michigan State University
East Lansing, Michigan, 48824
Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113
The Parkinsons & Movement Disorder Institute
Fountain Valley, California, 92708
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Pacific Health Research & Education Institute
Honolulu, Hawaii, 96819
University of Texas Health Science Center
Houston, Texas, 77030
University of California
Irvine, California, 92697
Health Quest Kingston
Kingston, New York, 12401
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034
University of Nevada School of Medicine
Las Vegas, Nevada, 89102
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky Medical Center
Lexington, Kentucky, 40536
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55414
Institute of Neurodegenerative Disorders
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Weill Medical College of Cornell University
New York, New York, 20021
Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14618
University of Utah
Salt Lake City, Utah, 84108
University of California San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
LSU Health Science Center
Shreveport, Louisiana, 71103
Washington University
St Louis, Missouri, 63110
Atlantic Neuroscience Institute
Summit, New Jersey, 07901
Banner Sun Health Research Institute
Sun City, Arizona, 85315
University of South Florida
Tampa, Florida, 33613
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456
Canada7 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, t6g 2g3
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
Ottawa Hospital Civic Site
Ottawa, Ontario, K1Y 4E9
Centre Hospitalier Affilie
Québec, Quebec, G1J 1Z4
The Centre for Addiction and Mental Health
Toronto, Ontario, m3b 2s7
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease
The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.
Read the detailed description
The study will enroll 336 participants in this multi-center study at approximately 56 sites across the US and Canada. In this study, we are comparing 10 mg of Isradipine to Placebo for treatment of newly diagnosed PD patients. Isradipine has been approved by the Food and Drug Administration (FDA) to treat high blood pressure but is considered investigational in this study, as it has not been approved for use in patients with PD.Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that Isradipine may prevent the development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in some patients with PD. The first study with isradipine controlled release (CR) in patients with early PD and normal blood pressure found that the drug was reasonably well tolerated and safe. The controlled release formulation of isradipine is not available for use and therefore this study is using the immediate release formulation. Eligible participants will be followed for up to 36 months and will be expected to complete 12 in-person visits and 4 telephone visits. The study visits will include clinical assessment of motor, neuropsychiatric and cognitive testing as well as collection of blood and urine samples. Study drug will taken twice daily, in the morning and in the evening with or without food. Prior to taking study drug, study participants will be required to take their blood pressure with a home blood pressure device provided to them for use in this study.
- Conditions
- Parkinson Disease
- Being tested
- Isradipine, Placebo (for Isradipine)
- Keywords
- Parkinson, Parkinson Disease, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsradipineDrug
Oral capsules Isradipine IR, up to 10 mg, taken twice daily
Placebo (for Isradipine)Drug
Sugar Pill manufactured to look like Isradipine but has no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Isradipine | Active comparator | Oral capsule of up to 5 mg of isradipine taken twice daily for 36 months. Receives: Drug: Isradipine |
| Placebo (for Isradipine) | Placebo comparator | Oral capsule taken twice daily for 36 months. Receives: Drug: Placebo (for Isradipine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 months of treatment
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.
Measured: Baseline to 36 months of treatment
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 months of treatment
Risk of Need for Antiparkinsonian Therapy
Number of participants with need for Antiparkinsonian Therapy.
Measured: Baseline to 36 months of treatment
Risk of Need for Dyskinesia
Number of participants with need for Dyskinesia Therapy.
Measured: Baseline to 36 months of treatment
Risk of Need for Fluctuations
Number of participants with need for Fluctuations Therapy.
Measured: Baseline to 36 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Michael J. Fox Foundation for Parkinson's Research, The Parkinson Study Group
- Responsible party
- Principal investigator, Robert Holloway, University of Rochester
- Investigators
- Tanya Simuni, MD, Principal investigator, Northwestern UniversityRobert Holloway, MD MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168842
- Sponsor's protocol ID
- STEADY-PD III
- Other IDs
- U01NS080818-01A1, U01NS080840-01A1
- Status last verified
- Jan 2020
- First submitted
- 18 Jun 2014
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Di Luca DG, Macklin EA, Hodgeman K, Lopez G, Pothier L, Callahan KF, Lowell J, Chan J, Videnovic A, Lungu C, Lang AE, Litvan I, Schwarzschild MA, Simuni T. Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials. Neurol Clin Pract. 2023 Feb;13(1):e200113. doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18.
PubMed 36865634Venuto CS, Yang L, Javidnia M, Oakes D, James Surmeier D, Simuni T. Isradipine plasma pharmacokinetics and exposure-response in early Parkinson's disease. Ann Clin Transl Neurol. 2021 Mar;8(3):603-612. doi: 10.1002/acn3.51300. Epub 2021 Jan 18.
PubMed 33460320Parkinson Study Group STEADY-PD III Investigators. Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial. Ann Intern Med. 2020 May 5;172(9):591-598. doi: 10.7326/M19-2534. Epub 2020 Mar 31.
PubMed 32227247McFarthing K, Simuni T. Clinical Trial Highlights: Phase III Study in Spotlight. J Parkinsons Dis. 2019;9(1):3-4. doi: 10.3233/JPD-190002. No abstract available.
PubMed 30741695
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease
- ClinicalTrials.gov ID
- NCT02168842
- Acronym / sponsor ID
- STEADY-PD III
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Parkinson Disease, Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Michael J. Fox Foundation for Parkinson's Research, The Parkinson Study Group
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 14 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.
Detailed description
The study will enroll 336 participants in this multi-center study at approximately 56 sites across the US and Canada. In this study, we are comparing 10 mg of Isradipine to Placebo for treatment of newly diagnosed PD patients. Isradipine has been approved by the Food and Drug Administration (FDA) to treat high blood pressure but is considered investigational in this study, as it has not been approved for use in patients with PD.Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that Isradipine may prevent the development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in some patients with PD. The first study with isradipine controlled release (CR) in patients with early PD and normal blood pressure found that the drug was reasonably well tolerated and safe. The controlled release formulation of isradipine is not available for use and therefore this study is using the immediate release formulation. Eligible participants will be followed for up to 36 months and will be expected to complete 12 in-person visits and 4 telephone visits. The study visits will include clinical assessment of motor, neuropsychiatric and cognitive testing as well as collection of blood and urine samples. Study drug will taken twice daily, in the morning and in the evening with or without food. Prior to taking study drug, study participants will be required to take their blood pressure with a home blood pressure device provided to them for use in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isradipine | Active comparator | Drug: IsradipineOral capsule of up to 5 mg of isradipine taken twice daily for 36 months. |
| Placebo (for Isradipine) | Placebo comparator | Drug: Placebo (for Isradipine)Oral capsule taken twice daily for 36 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with early idiopathic PD (presence of at least two out of three cardinal manifestations of PD). If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms
- Age equal or greater than 30 years at the time of diagnosis of PD
- Hoehn and Yahr stage less than or equal to 2
- Diagnosis of PD less than 3 years.
- Currently NOT receiving dopaminergic therapy (levodopa, dopamine agonist or MAO-B inhibitors) and NOT projected to require PD symptomatic therapy for at least 3 months from the baseline visit
Key exclusion criteria (20 listed)
- Subjects with a diagnosis of an atypical Parkinsonism
- Subjects unwilling or unable to give informed consent
- Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for consecutive 3 months or more at any point in the past
- History of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening or baseline visit defined as greater than or equal to 20 mmHg change in systolic BP and greater than or equal to 10 mmHg change in diastolic BP from sitting position to standing after 2 minutes, or baseline sitting BP less than 90/60
- History of congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsradipineOral capsules Isradipine IR, up to 10 mg, taken twice daily | Drug | Isradipine |
| Placebo (for Isradipine)Sugar Pill manufactured to look like Isradipine but has no active ingredients | Drug | Placebo (for Isradipine) |
Primary outcome
Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score
Time frame: Baseline to 36 months of treatment
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.
Adjusted Mean Change in Adjusted UPDRS Score
Time frame: Baseline to 36 months of treatment
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.
17 secondary outcomes
Adjusted Mean Change in LED
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in LED Cumulative
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in UPDRS Part IV
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in MDS-UPDRS nmEDL
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in MDS-UPDRS mEDL
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in UPDRS Score to 1 Year
Time frame: Baseline to 12 months of treatment
Adjusted Mean Change in UPDRS Part II
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in UPDRS Part III OFF
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in SE/ADL
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in Modified Rankin Score
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in MoCA Score
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in PDQ39 Total Score
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in Ambulatory Capacity
Time frame: Baseline to 36 months of treatment
Adjusted Mean Change in BDI Total Score
Time frame: Baseline to 36 months of treatment
Risk of Need for Antiparkinsonian Therapy
Time frame: Baseline to 36 months of treatment
Risk of Need for Dyskinesia
Time frame: Baseline to 36 months of treatment
Risk of Need for Fluctuations
Time frame: Baseline to 36 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36865634Di Luca DG, Macklin EA, Hodgeman K, Lopez G, Pothier L, Callahan KF, Lowell J, Chan J, Videnovic A, Lungu C, Lang AE, Litvan I, Schwarzschild MA, Simuni T. Enrollment of Participants From Marginalized Racial and Ethnic Groups: A Comparative Assessment of the STEADY-PD III and SURE-PD3 Trials. Neurol Clin Pract. 2023 Feb;13(1):e200113. doi: 10.1212/CPJ.0000000000200113. Epub 2023 Jan 18.
- Derived from this study: PubMed 33460320Venuto CS, Yang L, Javidnia M, Oakes D, James Surmeier D, Simuni T. Isradipine plasma pharmacokinetics and exposure-response in early Parkinson's disease. Ann Clin Transl Neurol. 2021 Mar;8(3):603-612. doi: 10.1002/acn3.51300. Epub 2021 Jan 18.
- Derived from this study: PubMed 32227247Parkinson Study Group STEADY-PD III Investigators. Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial. Ann Intern Med. 2020 May 5;172(9):591-598. doi: 10.7326/M19-2534. Epub 2020 Mar 31.
- Derived from this study: PubMed 30741695McFarthing K, Simuni T. Clinical Trial Highlights: Phase III Study in Spotlight. J Parkinsons Dis. 2019;9(1):3-4. doi: 10.3233/JPD-190002. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Simuni, MD principal investigator
Northwestern University
Robert Holloway, MD MPH principal investigator
University of Rochester
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isradipine in people with Parkinson Disease, run by University of Rochester at 54 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score (time frame: Baseline to 36 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168842, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.