Essential Head TremorPhase 3Btx-HTNCT02555982

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

A Phase 3 study testing BOTOX ® 200 Unités in people with Essential Head Tremor, run by University Hospital, Clermont-Ferrand at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Essential Head Tremor
What is being tested?: BOTOX ® 200 Unités
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 17 sitesFrance
Study dates: 27 Jun 2016to 1 Sep 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

France17 sites

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

Other trials in France

About this study

Official title: 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

Read the 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.

Conditions: Essential Head Tremor
Being tested: BOTOX ® 200 Unités, Placebo
Keywords: Essential Head tremor, Botulinum toxin injections, Quality of life, Embarrassment assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOTOX ® 200 UnitésDrug
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).
PlaceboDrug
Control group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis).

Study groups in NCT02555982
Study group	Role	What they receive
EXPERIMENTAL GROUP	Experimental	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). Receives: Drug: BOTOX ® 200 Unités
CONTROL GROUP	Other	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). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI)
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).
Measured: at 18 weeks
% of responders defined with CGI
Measured: at 6 weeks
% of responders defined with CGI
Measured: at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Measured: at day 0
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Measured: at 6 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Measured: at 12 weeks

Secondary outcomes (27)

The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Measured: at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Measured: at 24 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Measured: at day 0
The Essential Tremor Embarrassment Assessment (ETEA)
Measured: at 6 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Measured: at 12 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Measured: at 18 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Measured: at 24 weeks
The Quality of life in Essential Tremor (QUEST)
Measured: at day 0
The Quality of life in Essential Tremor (QUEST)
Measured: at 6 weeks
The Quality of life in Essential Tremor (QUEST)
Measured: at 12 weeks
The Quality of life in Essential Tremor (QUEST)
Measured: at 18 weeks
The Quality of life in Essential Tremor (QUEST)
Measured: at 24 weeks
tremor frequency measured by accelerometer
Measured: at day 0
tremor frequency measured by accelerometer
Measured: at 6 weeks
tremor frequency measured by accelerometer
Measured: at 12 weeks
tremor frequency measured by accelerometer
Measured: at 18 weeks
tremor frequency measured by accelerometer
Measured: at 24 weeks
mean peak amplitude measured by accelerometer
Measured: at day 0
mean peak amplitude measured by accelerometer
Measured: at 6 weeks
mean peak amplitude measured by accelerometer
Measured: at 12 weeks
mean peak amplitude measured by accelerometer
Measured: at 18 weeks
mean peak amplitude measured by accelerometer
Measured: at 24 weeks
distance traveled measured by accelerometer
Measured: at day 0
distance traveled measured by accelerometer
Measured: at 6 weeks
distance traveled measured by accelerometer
Measured: at 12 weeks
distance traveled measured by accelerometer
Measured: at 18 weeks
distance traveled measured by accelerometer
Measured: at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 20161 Sep 2022

First posted22 Sep 2015 (estimated)
Study start27 Jun 2016
Primary completion17 Sep 2021
Study completion1 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Essential Head TremorStudies of the same condition, open and under way.
More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02555982
Sponsor's protocol ID: CHU-0245
Other IDs: 2015-000162-59, 2015
Acronym: Btx-HT
Status last verified: Apr 2026
First submitted: 8 Sep 2015
Last updated: 21 Apr 2026
Results posted: No

Publications

Marques A, Pereira B, Simonetta-Moreau M, Castelnovo G, De Verdal M, Fluchere F, Laurencin C, Degos B, Tir M, Kreisler A, Blanchet-Fourcade G, Guehl D, Colin O, Poujois A, Sangla S, Tatu L, Derost P, Gayraud D, Tranchant C, Amarantini D, Devos D, Rascol O, Corvol JC, Durif F, Rieu I; Btx-HT Study Group. Trial of Botulinum Toxin for Isolated or Essential Head Tremor. N Engl J Med. 2023 Nov 9;389(19):1753-1765. doi: 10.1056/NEJMoa2304192.
PubMed 37937777

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02555982
Acronym / sponsor ID: Btx-HT / CHU-0245
Conditions: Essential Head Tremor
Keywords: Essential Head tremor, Botulinum toxin injections, Quality of life, Embarrassment assessment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: University Hospital, Clermont-FerrandUniversity, hospital or other
Collaborators: Allergan
Study start: 27 Jun 2016 (actual)
Primary completion: 17 Sep 2021 (actual)
Study completion: 1 Sep 2022 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

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).

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
EXPERIMENTAL GROUP	Experimental	Drug: BOTOX ® 200 UnitésPatients 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).
CONTROL GROUP	Other	Drug: PlaceboPatients 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).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOTOX ® 200 UnitésPatients 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	EXPERIMENTAL GROUP
PlaceboControl group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis).	Drug	CONTROL GROUP

Primary outcome

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).
% of responders defined with CGI
Time frame: at 6 weeks
% of responders defined with CGI
Time frame: at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time frame: at day 0
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time frame: at 6 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time frame: at 12 weeks

27 secondary outcomes

The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time frame: at 18 weeks
The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)
Time frame: at 24 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time frame: at day 0
The Essential Tremor Embarrassment Assessment (ETEA)
Time frame: at 6 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time frame: at 12 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time frame: at 18 weeks
The Essential Tremor Embarrassment Assessment (ETEA)
Time frame: at 24 weeks
The Quality of life in Essential Tremor (QUEST)
Time frame: at day 0
The Quality of life in Essential Tremor (QUEST)
Time frame: at 6 weeks
The Quality of life in Essential Tremor (QUEST)
Time frame: at 12 weeks
The Quality of life in Essential Tremor (QUEST)
Time frame: at 18 weeks
The Quality of life in Essential Tremor (QUEST)
Time frame: at 24 weeks
tremor frequency measured by accelerometer
Time frame: at day 0
tremor frequency measured by accelerometer
Time frame: at 6 weeks
tremor frequency measured by accelerometer
Time frame: at 12 weeks
tremor frequency measured by accelerometer
Time frame: at 18 weeks
tremor frequency measured by accelerometer
Time frame: at 24 weeks
mean peak amplitude measured by accelerometer
Time frame: at day 0
mean peak amplitude measured by accelerometer
Time frame: at 6 weeks
mean peak amplitude measured by accelerometer
Time frame: at 12 weeks
mean peak amplitude measured by accelerometer
Time frame: at 18 weeks
mean peak amplitude measured by accelerometer
Time frame: at 24 weeks
distance traveled measured by accelerometer
Time frame: at day 0
distance traveled measured by accelerometer
Time frame: at 6 weeks
distance traveled measured by accelerometer
Time frame: at 12 weeks
distance traveled measured by accelerometer
Time frame: at 18 weeks
distance traveled measured by accelerometer
Time frame: at 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Results publication: PubMed 37937777Marques A, Pereira B, Simonetta-Moreau M, Castelnovo G, De Verdal M, Fluchere F, Laurencin C, Degos B, Tir M, Kreisler A, Blanchet-Fourcade G, Guehl D, Colin O, Poujois A, Sangla S, Tatu L, Derost P, Gayraud D, Tranchant C, Amarantini D, Devos D, Rascol O, Corvol JC, Durif F, Rieu I; Btx-HT Study Group. Trial of Botulinum Toxin for Isolated or Essential Head Tremor. N Engl J Med. 2023 Nov 9;389(19):1753-1765. doi: 10.1056/NEJMoa2304192.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Franck Durif principal investigator

University Hospital, Clermont-Ferrand

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BOTOX ® 200 Unités in people with Essential Head Tremor, run by University Hospital, Clermont-Ferrand at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical state improvement of patients evaluated by the Clinical Global Impression of Change (CGI) (time frame: at 18 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.