CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 54 enrolled
Drug / intervention
BoNT-Adrug
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/NCT02427646
NCT02427646Phase 2Unknown
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Use of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson Disease

Western University, Canada·interventional·Posted Apr 28, 2015·Updated Aug 20, 2019

In Brief

A Phase 2 clinical trial evaluating BoNT-A for Tremor. Targeting 54 participants.

Detailed Summary

The present study attempts to fill a critical knowledge gap of BoNT A in tremor management by studying the efficacy of IncobotulinumtoxinA (Xeomin®) injection for hand tremor in essential tremor and idiopathic Parkinson disease using data regarding composition of tremor obtained through sophisticated, yet clinically accessible multi-sensor based kinematic information.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTremor
Countries--
Collaborators--

Timeline

Phase 2UnknownOverdue
201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2015
Enrollment StartOct 1, 2011
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.2 years ago

Interventions

BoNT-Adrug

A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.