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NCT05885360 · ClinicalTrials.gov registry record · Phase 4
Istradefylline Effect Protocol on Parkinson's Disease Tremor
A Phase 4 study of Parkinson Disease and Tremor, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT05885360: Completed Phase 4 study of Parkinson Disease and Tremor, sponsored by Georgetown University.
NCT05885360 is a Phase 4 study of Parkinson Disease and Tremor that has completed, run by Georgetown University. The registered enrollment target is 27 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05885360, a Phase 4 study of Parkinson Disease and Tremor, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an investigator-initiated trial. In this 6-month open label, single arm, exploratory pilot study, the investigator intends to enroll a pilot sample of 25 patients with Parkinson's disease who are being started on the novel FDA approved medication "Istradefylline'' as an add on therapy for management of their motor symptoms (based on the judgment of the movement disorders specialist, if patients are in sub-optimal management of their symptoms on maximum tolerable dose of their dopaminergic medications). The investigator will evaluate their motor symptoms before starting the new medication, including their MDS-UPDRS total and MDS-UPDRS-III scores.
Primary Outcome
· Evaluation of changes in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III tremor score ·· Evaluation of changes in the Movement Disorders Society - United Parkinson's Disease Rating Scale part III tremor score, with the minimum value being 0 and the maximum value being 4 for each sub-scale (rest, kinetic and postural), with a higher score signifying a worse outcome.
Conditions Studied
Interventions
- DRUG Istradefylline Pill
Study Locations (1)
Virginia
- Georgetown University Hospital - McLean
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-01-20 |
| Est. Completion | 2025-02-21 |
| Phase | Phase 4 |
What the finished NCT05885360 record still lists
NCT05885360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 1 intervention - of which Istradefylline Pill is the first listed.
NCT05885360 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05885360 about?
NCT05885360 is a clinical study titled "Istradefylline Effect Protocol on Parkinson's Disease Tremor". This is an investigator-initiated trial. In this 6-month open label, single arm, exploratory pilot study, the investigator intends to enroll a pilot sample of 25 patients with Parkinson's disease who are being started on the novel FDA approved medication "Istradefylline'' as an add on therapy for ma...
What is the current status of trial NCT05885360?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2023-01-20. Estimated completion is 2025-02-21.
What conditions does trial NCT05885360 study?
This clinical trial studies the following conditions: Parkinson Disease, Tremor.
What interventions are being tested in trial NCT05885360?
The interventions under investigation include: Istradefylline Pill (DRUG).
Who is sponsoring clinical trial NCT05885360?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05885360 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05885360's enrollment target sits among peer trials
27 221st of 297 higher than 76 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease 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.
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