CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 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/NCT02207946
NCT02207946Phase 2Completed
CompareCT.gov

Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of NT 201 in the Unilateral Treatment of Essential Tremor of the Upper Limb

Merz Pharmaceuticals GmbH·interventional·Posted Aug 4, 2014·Updated Feb 18, 2021

In Brief

A Phase 2 clinical trial evaluating IncobotulinumtoxinA and Placebo for Essential Tremor of the Upper Limbs. Completed, enrolled 30 participants across 6 sites in 2 countries.

Detailed Summary

The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Tremor of the Upper Limbs
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartDec 5, 2014
Primary CompletionMay 9, 2016
Study CompletionSep 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.9 years ago

Interventions

IncobotulinumtoxinAdrug

Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Placebodrug

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).