CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Onabotulinumtoxin A Injection +1 moredrug
Likely dose
Onabotulinumtoxin A Injection 10 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03301272
NCT03301272Phase 2Completed

Effectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot Study

University of North Carolina, Chapel Hill·interventional·Posted Oct 4, 2017·Updated Aug 17, 2020

In Brief

A Phase 2 clinical trial evaluating Onabotulinumtoxin A Injection and Placebo for Parkinson Disease. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartMar 22, 2018
Primary CompletionAug 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.7 years ago

Interventions

Onabotulinumtoxin A Injectiondrug

Reconstituted 10 units/0.1 mL. Administered intramuscular once

Placeboother

0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once.