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NCT02954978 · ClinicalTrials.gov registry record · Phase 2
Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
A Phase 2 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT02954978 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 75 participants.
The verdict
NCT02954978, a Phase 2 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs) that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and promotes autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA neurons and improvement of motor function in PD models. For these studies, Nilotinib (1-10mg/kg daily) was used at significantly less than the clinically approved dose (up to 1200mg daily) in CML.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Nilotinib 150mg oral capsule [Tasigna]
- DRUG Nilotinib 300mg oral capsule [Tasigna]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-01 |
| Est. Completion | 2020-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02954978
The ClinicalTrials.gov registry entry for NCT02954978 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Oral Capsule is the first listed.
NCT02954978 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02954978 about?
NCT02954978 is a clinical study titled "Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease". Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs) that primarily contain aggre...
What is the current status of trial NCT02954978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-01. Estimated completion is 2020-07.
What interventions are being tested in trial NCT02954978?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Nilotinib 150mg oral capsule [Tasigna] (DRUG), Nilotinib 300mg oral capsule [Tasigna] (DRUG).
Who is sponsoring clinical trial NCT02954978?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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