drugset / Trial / NCT02168842
Efficacy of Isradipine in Early Parkinson Disease
Phase 3
Completed
336 enrolled
University of Rochester
Michael J. Fox Foundation for Parkinson's Research · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabThe Parkinson Study Group · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.
Timeline
- Start
- 2014-11
- Primary completion
- 2018-11
- Completion
- 2018-11
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.
- Venuto 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.
- Parkinson 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.
- McFarthing 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isradipine | Small molecule | 5 mg | Oral |