CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
incobotulinumtoxinA +1 moredrug
Likely dose
Not stated in 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/NCT02419313
NCT02419313Phase 2Completed
CompareCT.gov

Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach

Yale University·interventional·Posted Apr 17, 2015·Updated Mar 14, 2016

In Brief

A Phase 2 clinical trial evaluating incobotulinumtoxinA and Saline for Parkinson and Tremor. Completed, enrolled 33 participants across 1 site.

Detailed Summary

The scientific aim of this study is to investigate the efficacy and safety of incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson"s disease. Our hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases the tremor amplitude and frequency leading to improvement of the patient"s function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson, Tremor
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartAug 1, 2012
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.2 years ago

Interventions

incobotulinumtoxinAdrug

Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.

Salinedrug

same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.