AzTrials
AzTrials

Parkinson DiseasePhase 2STEADY-PDNCT00909545

Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease

A Phase 2 study testing Isradipine CR 5mg, Isradipine CR 10mg and Isradipine CR 20mg in people with Parkinson Disease, run by Northwestern University at 20 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. 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 CR 5mg, Isradipine CR 10mg and Isradipine CR 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
20 sitesin 2 countries
Study dates
Jul 2009to Feb 2012
Phase
Phase 2
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. 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.

Who cannot join

  • 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 <90/60
  • History of congestive heart failure
Show all 20Show fewer
  • History of bradycardia defined as heart rate <55
  • 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 electrocardiogram.
  • 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 calcium channel blockers within 6 months of baseline
  • Subjects with history of hypertension treated with a maximum of 2 other antihypertensive agents will be allowed provided that the doses 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 physician or cardiologist.
  • Use of grapefruit juice, Ginkgo biloba, St. John's wart and/or ginseng will be prohibited during the study (as they interfere with the metabolism of isradipine).
  • Presence of cognitive dysfunction defined by a Mini Mental Status Exam ( MMSE) score < 26 at screening
  • Subjects with clinically significant depression as determined by a Beck Depression Inventory (BDI) score >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

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States18 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30329

  • Boston University

    Boston, Massachusetts, 02118

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Michigan State University

    East Lansing, Michigan, 48824

  • Park Nicolet Clinic

    Golden Valley, Minnesota, 55427

  • Pacific Health Institute

    Honolulu, Hawaii, 96817

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Tennessee

    Memphis, Tennessee, 38104

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14618

  • Washington University

    St Louis, Missouri, 63110

  • Parkinson Institute

    Sunnyvale, California, 94805

  • University of South Flordia

    Tampa, Florida, 33606

Other trials in United States

Canada2 sites

  • Ottowa Hospital Civic Site

    Ottawa, Ontario, K1Y 4E9

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: A Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson Disease

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.

Read the detailed description

There is solid scientific rational and preclinical data supporting a clinical trial of isradipine CR as a potential disease modifying agent in early PD. Human pharmacokinetic data demonstrate that it is feasible to achieve the serum concentrations in humans that were neuroprotective in preclinical models with the FDA approved dosage range. Pilot data demonstrate acceptable tolerability of isradipine CR in the PD population. Tolerability is inversely proportional to the dosage dependent. Considering that tolerability of isradipine CR is inversely proportional to the dosage exposure, it is essential to proceed with the dose selection tolerability study in preparation for the future efficacy trials.

The tolerability, defined as the ability to complete the study, of three dosages of isradipine CR relative to placebo in subjects with early Parkinson's disease will be examined first. The dosage that is tolerable and demonstrates preliminary efficacy will be evaluated further in the future pivotal efficacy studies.

Being tested
Isradipine CR 5mg, Isradipine CR 10mg, Isradipine CR 20mg, Placebo
Keywords
Early Parkinson 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.

  • Isradipine CR 5mgDrug

    Also called Isradipine CR, Dynacirc CR

    5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily

  • Isradipine CR 10mgDrug

    Also called Isradipine CR, Dynacirc CR

    10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily

  • Isradipine CR 20mgDrug

    Also called Isradipine CR, Dynacirc CR

    20mg dose: 4 Dynacirc CR 5mg tablets once daily

  • PlaceboDrug

    4 Placebo to Match (PTM) tablets once daily

Study groups in NCT00909545
Study groupRoleWhat they receive
Isradipine CR 5mgActive comparatorIsradipine CR 5mg/day
Receives: Drug: Isradipine CR 5mg
Isradipine CR 10mgActive comparatorIsradipine CR 10mg/day
Receives: Drug: Isradipine CR 10mg
Isradipine CR 20mgActive comparatorIsradipine CR 20mg/day
Receives: Drug: Isradipine CR 20mg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

Secondary outcomes (31)

  1. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  2. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  3. 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

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  4. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  5. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  6. 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).

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  7. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  8. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  9. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  10. Vital Signs: Change in Systolic Standing

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  11. Vital Signs: Change in Systolic Supine

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  12. Vital Signs: Change in Diastolic Standing

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  13. Vital Signs: Change in Diastolic Supine

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  14. Vital Signs: Change in Pulse Standing

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  15. Vital Signs: Change in Pulse Supine

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  16. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  17. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  18. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  19. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  20. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  21. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  22. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  23. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  24. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  25. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  26. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  27. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  28. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  29. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  30. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

  31. 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.

    Measured: Baseline to 12 months or the time to require dopaminergic therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2011
  4. Study completionFeb 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909545
Sponsor's protocol ID
CTCC Protocol #124
Acronym
STEADY-PD
Status last verified
Apr 2013
First submitted
26 May 2009
Last updated
17 Apr 2013
Data monitoring committee
Yes

Publications

  • Parkinson Study Group. Effects of tocopherol and deprenyl on the progression of disability in early Parkinson's disease. N Engl J Med. 1993 Jan 21;328(3):176-83. doi: 10.1056/NEJM199301213280305.

    PubMed 8417384

  • Parkinson Study Group. Dopamine transporter brain imaging to assess the effects of pramipexole vs levodopa on Parkinson disease progression. JAMA. 2002 Apr 3;287(13):1653-61. doi: 10.1001/jama.287.13.1653.

    PubMed 11926889

  • Parkinson Study Group. A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease. Arch Neurol. 2004 Apr;61(4):561-6. doi: 10.1001/archneur.61.4.561.

    PubMed 15096406

  • NINDS NET-PD Investigators. A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease. Neurology. 2006 Mar 14;66(5):664-71. doi: 10.1212/01.wnl.0000201252.57661.e1. Epub 2006 Feb 15.

    PubMed 16481597

  • NINDS NET-PD Investigators. A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology. 2007 Jan 2;68(1):20-8. doi: 10.1212/01.wnl.0000250355.28474.8e.

    PubMed 17200487

  • Becker C, Jick SS, Meier CR. Use of antihypertensives and the risk of Parkinson disease. Neurology. 2008 Apr 15;70(16 Pt 2):1438-44. doi: 10.1212/01.wnl.0000303818.38960.44. Epub 2008 Feb 6.

    PubMed 18256367

  • Braak H, Ghebremedhin E, Rub U, Bratzke H, Del Tredici K. Stages in the development of Parkinson's disease-related pathology. Cell Tissue Res. 2004 Oct;318(1):121-34. doi: 10.1007/s00441-004-0956-9. Epub 2004 Aug 24.

    PubMed 15338272

  • Chan CS, Guzman JN, Ilijic E, Mercer JN, Rick C, Tkatch T, Meredith GE, Surmeier DJ. 'Rejuvenation' protects neurons in mouse models of Parkinson's disease. Nature. 2007 Jun 28;447(7148):1081-6. doi: 10.1038/nature05865. Epub 2007 Jun 10.

    PubMed 17558391

  • Christensen HR, Antonsen K, Simonsen K, Lindekaer A, Bonde J, Angelo HR, Kampmann JP. Bioavailability and pharmacokinetics of isradipine after oral and intravenous administration: half-life shorter than expected? Pharmacol Toxicol. 2000 Apr;86(4):178-82. doi: 10.1034/j.1600-0773.2000.d01-32.x.

    PubMed 10815751

  • de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.

    PubMed 16713924

  • Dodel RC, Singer M, Kohne-Volland R, Szucs T, Rathay B, Scholz E, Oertel WH. The economic impact of Parkinson's disease. An estimation based on a 3-month prospective analysis. Pharmacoeconomics. 1998 Sep;14(3):299-312. doi: 10.2165/00019053-199814030-00006.

    PubMed 10186468

  • Dorsey ER, Constantinescu R, Thompson JP, Biglan KM, Holloway RG, Kieburtz K, Marshall FJ, Ravina BM, Schifitto G, Siderowf A, Tanner CM. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030. Neurology. 2007 Jan 30;68(5):384-6. doi: 10.1212/01.wnl.0000247740.47667.03. Epub 2006 Nov 2.

    PubMed 17082464

  • Elm JJ, Goetz CG, Ravina B, Shannon K, Wooten GF, Tanner CM, Palesch YY, Huang P, Guimaraes P, Kamp C, Tilley BC, Kieburtz K; NET-PD Investigators. A responsive outcome for Parkinson's disease neuroprotection futility studies. Ann Neurol. 2005 Feb;57(2):197-203. doi: 10.1002/ana.20361.

    PubMed 15668964

  • Fahn S, Oakes D, Shoulson I, Kieburtz K, Rudolph A, Lang A, Olanow CW, Tanner C, Marek K; Parkinson Study Group. Levodopa and the progression of Parkinson's disease. N Engl J Med. 2004 Dec 9;351(24):2498-508. doi: 10.1056/NEJMoa033447.

    PubMed 15590952

  • Gill DJ, Freshman A, Blender JA, Ravina B. The Montreal cognitive assessment as a screening tool for cognitive impairment in Parkinson's disease. Mov Disord. 2008 May 15;23(7):1043-1046. doi: 10.1002/mds.22017.

    PubMed 18381646

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isradipine CR 5mg, Isradipine CR 10mg and Isradipine CR 20mg in people with Parkinson Disease, run by Northwestern University at 20 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 5 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 Apr 2013). 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?

Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR. (time frame: Baseline to 12 months or the time to require dopaminergic therapy). 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 NCT00909545, which also lists 35 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 17 Apr 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in