Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor (Btx-HT)

April 16, 2026 updated by: University Hospital, Clermont-Ferrand

Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor by a Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Type of study: multi-center, randomized, double-blind, parallel-group, placebo-controlled therapeutic clinical trial.

Number of centers: 19 centers : Clermont-Ferrand, Paris (Fondation Rothschild, APHP, Hôpital Lariboisière, Hôpital Avicenne de Bobigny), Toulouse, Lyon, Amiens, Bordeaux, Narbonne, Lille, Strasbourg, Nîmes, Marseille, Besançon, Aix, Montpellier, Pau,Poitiers

Medical product Botulinum toxin type A, 200U (BOTOX ® 200 Unités, Allergan)

Patients

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).

Study Performance Patients will be injected twice, with an interval of 12 weeks (D0 and 12W). On D0, patients will receive 75U of Btx A (BOTOX ® - Allergan) in each splenius capitis; at 12W, patients will receive the same dose as on D0 (if the first injection is effective according to the CGI- improvement by at least two points), or a higher dose (100U) (if the first injection is ineffective according to the CGI- non improvement or improvement by less than two points).

Patients will be assessed at baseline D0, 6 weeks (6W), 12 weeks (12W), 18 weeks (18W) and 24 weeks (24W) after D0 as follows:

Visit 1 (baseline):

  • Signature of an informed consent form.
  • Demographic and clinical characteristics (sex, age, disease duration, treatments).
  • Clinical evaluation:
  • Neurological evaluation: Fahn-Tolosa-Marin Tremor Rating Scale (TRS), Tsui Scale.
  • The Quality of life in Essential Tremor (QUEST), the Essential Tremor Embarrassment Assessment (ETEA).
  • Accelerometer recording and videotape recording.

Visits at 6W, 12W, 18W and 24W

  • Clinical evaluation:
  • TRS.
  • CGI.
  • QUEST / ETEA.
  • Accelerometer recording and videotape recording.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • Centre Hospitalier Pays D'Aix
      • Amiens, France
        • CHU d'Amiens
      • Besançon, France
        • Hopital Jean Minjoz
      • Bordeaux, France
        • Hôpital Haut-Lévêque
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand
      • Lille, France
        • Hôpital R Salendro
      • Lyon, France
        • Hôpital neurologique
      • Marseille, France
        • Hopital de la Timone
      • Narbonne, France
        • CH Narbonne
      • Nîmes, France
        • Hopital Caremeau
      • Paris, France
        • Hôpital Lariboisière
      • Paris, France
        • AP-HP
      • Paris, France
        • Fondation Rothschild
      • Paris, France
        • Hôptal Avicenne de Bobigny
      • Poitiers, France
        • CHU De Poitiers
      • Strasbourg, France
        • Hopital de Hautepierre
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients suffering from a head tremor without (isolated) or with associated
  • tremor in any other body parts.
  • The HT must be troublesome for the patients (TRS 2 for the head tremor
  • severity item).
  • Patients never treated with botulinum toxin or not treated with botulinum toxin for this indication for at least 4 months.
  • Men or women aged from 18 to 80 years old.
  • Social security coverage.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Patients with tremor from cerebellar syndrome (multiple sclerosis, etc.).
  • Patients with a predominant dystonic jerky or myoclonic head tremor using
  • the Tsui scale (>1).
  • Oral treatments for HT are allowed but must be stable during the study.
  • Any contra-indication to Botulinum toxin.
  • Women without efficient contraception.
  • Patients under supervision or (legal) guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EXPERIMENTAL GROUP

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: 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).
Other: CONTROL GROUP

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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI)
Time Frame: at 18 weeks
clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI) (improvement by at least two points) measured 6 weeks after the 2nd injection of Btx (at 18W).
at 18 weeks
% of responders defined with CGI
Time Frame: at 6 weeks
at 6 weeks
% of responders defined with CGI
Time Frame: at 18 weeks
at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time Frame: at day 0
at day 0
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time Frame: at 6 weeks
at 6 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time Frame: at 12 weeks
at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time Frame: at 18 weeks
at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time Frame: at 24 weeks
at 24 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time Frame: at day 0
at day 0
The Essential Tremor Embarrassment Assessment (ETEA)
Time Frame: at 6 weeks
at 6 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time Frame: at 12 weeks
at 12 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time Frame: at 18 weeks
at 18 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time Frame: at 24 weeks
at 24 weeks
The Quality of life in Essential Tremor (QUEST)
Time Frame: at day 0
at day 0
The Quality of life in Essential Tremor (QUEST)
Time Frame: at 6 weeks
at 6 weeks
The Quality of life in Essential Tremor (QUEST)
Time Frame: at 12 weeks
at 12 weeks
The Quality of life in Essential Tremor (QUEST)
Time Frame: at 18 weeks
at 18 weeks
The Quality of life in Essential Tremor (QUEST)
Time Frame: at 24 weeks
at 24 weeks
tremor frequency measured by accelerometer
Time Frame: at day 0
at day 0
tremor frequency measured by accelerometer
Time Frame: at 6 weeks
at 6 weeks
tremor frequency measured by accelerometer
Time Frame: at 12 weeks
at 12 weeks
tremor frequency measured by accelerometer
Time Frame: at 18 weeks
at 18 weeks
tremor frequency measured by accelerometer
Time Frame: at 24 weeks
at 24 weeks
mean peak amplitude measured by accelerometer
Time Frame: at day 0
at day 0
mean peak amplitude measured by accelerometer
Time Frame: at 6 weeks
at 6 weeks
mean peak amplitude measured by accelerometer
Time Frame: at 12 weeks
at 12 weeks
mean peak amplitude measured by accelerometer
Time Frame: at 18 weeks
at 18 weeks
mean peak amplitude measured by accelerometer
Time Frame: at 24 weeks
at 24 weeks
distance traveled measured by accelerometer
Time Frame: at day 0
at day 0
distance traveled measured by accelerometer
Time Frame: at 6 weeks
at 6 weeks
distance traveled measured by accelerometer
Time Frame: at 12 weeks
at 12 weeks
distance traveled measured by accelerometer
Time Frame: at 18 weeks
at 18 weeks
distance traveled measured by accelerometer
Time Frame: at 24 weeks
at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franck Durif, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHU-0245
  • 2015-000162-59 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Head Tremor

Clinical Trials on BOTOX ® 200 Unités

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings