STEADY-PD3

The purpose of the study is to determine whether treatment with 10 mg of isradipine daily is effective in slowing the progression of Parkinson disease disability.

Source:  

http://www.parkinson-study-group.org/clinical-trials?rq=sure%20pd3

In Release 2.0 from December 2020, participants from the Steady-PD (STEADY-PD3) cohort are represented in AMP PD clinical and WGS data. Of 92 Steady-PD cohort participants whose clinical records met AMP PD minimum clinical data criteria, 91 have corresponding WGS sample data (1 is represented by a linked WGS duplicate sample) and 91 are represented in the AMP PD joint genotyping dataset.

In Release 2.5 from May 2021, an additional 242 participants from the STEADY-PD3 cohort were added. Of 334 STEADY-PD3 cohort participants whose clinical records met AMP PD minimum clinical data criteria, 329” have corresponding WGS sample data (5 are represented by a linked WGS duplicate sample) and 334 are represented in the AMP PD joint genotyping dataset.

Inclusion Criteria

1. 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
2. Age equal or greater than 30 years at the time of diagnosis of PD
3. Hoehn and Yahr stage less than or equal to 2
4. Diagnosis of PD less than 3 years
5. 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
6. Use of amantadine and/or anticholinergics will be allowed provided that the dose is stable for 8 weeks prior to the baseline visit
7. 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
8. 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 

Exclusion Criteria

1. Subjects with a diagnosis of an atypical Parkinsonism
2. Subjects unwilling or unable to give informed consent
3. 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
4. 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
5. History of congestive heart failure
6. Clinically significant bradycardia
7. Presence of 2nd or 3rd degree atrioventricular block or other significant ECG abnormalities that in the investigator's opinion would compromise participation in study
8. Clinically significant abnormalities in the Screening Visit laboratory studies or ECG
9. Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
10. Prior exposure to isradipine or other dihydropyridine calcium channel blockers within 6 months of the baseline visit
11. 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
12. 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)
13. 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
14. Presence of cognitive dysfunction defined by a Montreal Cognitive assessment (MoCA) score of less than 26 at screening
15. Subjects with clinically significant depression as determined by a Beck Depression Inventory II (BDI) score greater than 15 at the screening visit
16. History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
17. History of use of an investigational drug within 30 days prior to the screening visit
18. History of brain surgery for PD
19. Allergy/sensitivity to isradipine or its matching placebo or their formulations
20. Pregnant or lactating woman

Source:

https://clinicaltrials.gov/ct2/show/NCT02168842

STEADY-PD3 is a 36-month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score in the practically defined ON state. Secondary outcome measures include clinically meaningful measures of disability progression in early PD: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function, and pharmacokinetic analysis. Rationale for the current design and alternative design approaches are discussed.

Participants first have a visit with the study doctor to determine if you are eligible to participate. For qualifying participants, a second visit will be scheduled to evaluate your general health, mood and movement. Blood samples will be taken at specific visits.

During the study you will be assigned randomly to receive either the active study drug, or a pill that looks like the study drug but has no active ingredients. You will continue to take the study drug or placebo for a total of 36 months. Your total participation time will be 37 months. There are 12 office visits and 4 telephone visits scheduled for this study to evaluate your general health, mood, movement ability to tolerate the study drug.

A link to the full protocol (.pdf) can be found in “Study Documents” at

https://clinicaltrials.gov/ct2/show/NCT02168842