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NCT03301272 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT03301272 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants.
The verdict
NCT03301272, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Purpose: Rest tremor in Parkinson's disease is notoriously difficult to treat through pharmacological measures, currently only predictably attenuated by the invasive deep brain stimulation surgery. The investigators hope to find some predictable and clinically meaningful attenuation of tremor with targeted use of onabotulinum toxin on muscles involved in creating the tremor. Participants: 16 subjects who meet United Kingdom (UK) brain bank criteria for Parkinson's disease with medically refractory rest tremor of at least 3 cm amplitude. Procedures (methods): Subjects will be blinded to receive either sham saline injection versus onabotulinum toxin injections directed to muscle groups felt to be clinically involved in causing the oscillatory movement of the tremor. Assessment of tremor severity and functional improvement from baseline after injection will occur within group (i.e. each subject will serve as their own control). Hypotheses: 1\. (A) Onabotulinumtoxin A significantly attenuates the amplitude of medically-refractory rest tremor of the upper limb in Parkinson's patients as compared to sham injections; as measured by reduction in the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) tremor subscore. 1\. (B) Onabotulinumtoxin A significantly improves the limb function of Parkinson's patients with medically-refractory rest tremor of the upper limb as compared to sham injections; as measured by an increase in Action Research Arm Test (ARAT) scores.
Interventions
- OTHER Placebo
- DRUG Onabotulinumtoxin A Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2019-08-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03301272
The ClinicalTrials.gov registry entry for NCT03301272 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03301272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03301272 about?
NCT03301272 is a clinical study titled "Effectiveness of Botox on Reducing Rest Tremor in Parkinson's Disease". Purpose: Rest tremor in Parkinson's disease is notoriously difficult to treat through pharmacological measures, currently only predictably attenuated by the invasive deep brain stimulation surgery. The investigators hope to find some predictable and clinically meaningful attenuation of tremor with t...
What is the current status of trial NCT03301272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2018-03-22. Estimated completion is 2019-08-21.
What interventions are being tested in trial NCT03301272?
The interventions under investigation include: Placebo (OTHER), Onabotulinumtoxin A Injection (DRUG).
Who is sponsoring clinical trial NCT03301272?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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