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Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor

NCT02555982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-21

No results posted yet for this study

Summary

Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses, leading to a reduction of pathological muscle movement. Very little information is available on its efficacy on HT. Two published reports suggested that local Btx A injections could be an effective and safe approach for treating HT. Given the scarcity of published data (small samples, open studies, different doses of Btx used, heterogeneous populations, several muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx injections in essential HT by a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.

Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment of head tremor.

Secondary objectives:

* \- To evaluate the tolerance of botulinum toxin injections in the treatment of head tremor.
* \- To evaluate the impact of botulinum toxin injections on the patients' quality of life and embarrassment.
* To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D accelerometer wireless portable system (Xsens MTw wireless motion tracker system) (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a new video system device to analyze head tremor characteristics

Conditions

  • Essential Head Tremor

Interventions

DRUG

BOTOX ® 200 Unités

Patients eligible for inclusion will be randomized to one of the two groups: * Experimental group: 60 patients will receive 2 injections of Btx A (BOTOX - Allergan), one on D0 and one at 12W (into each splenius capitis). * Control group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis).

DRUG

Placebo

Control group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis).

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Franck Durif · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-27
Primary Completion
2021-09-17
Completion
2022-09-01

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555982 on ClinicalTrials.gov