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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: Completed Phase 2 study, sponsored by Georgetown University.
NCT02954978 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety will be measured by assessing number of participants with adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.
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 |
What the finished NCT02954978 record still lists
NCT02954978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Oral Capsule is the first listed.
NCT02954978 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02954978's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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