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Completed

NCT Number: NCT02555982

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

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

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Key information

Conditions

Essential Head Tremor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Pays D'Aix, Aix-en-Provence, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BOTOX ® 200 Unités

Drug

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).

Placebo

Drug

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

Primary outcomes

  1. 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).

  2. % of responders defined with CGI

    Time frame: at 6 weeks

  3. % of responders defined with CGI

    Time frame: at 18 weeks

  4. The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)

    Time frame: at day 0

  5. The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)

    Time frame: at 6 weeks

  6. The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)

    Time frame: at 12 weeks

Secondary outcomes

  1. The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)

    Time frame: at 18 weeks

  2. The Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (sub item head)

    Time frame: at 24 weeks

  3. The Essential Tremor Embarrassment Assessment (ETEA)

    Time frame: at day 0

  4. The Essential Tremor Embarrassment Assessment (ETEA)

    Time frame: at 6 weeks

  5. The Essential Tremor Embarrassment Assessment (ETEA)

    Time frame: at 12 weeks

  6. The Essential Tremor Embarrassment Assessment (ETEA)

    Time frame: at 18 weeks

  7. The Essential Tremor Embarrassment Assessment (ETEA)

    Time frame: at 24 weeks

  8. The Quality of life in Essential Tremor (QUEST)

    Time frame: at day 0

  9. The Quality of life in Essential Tremor (QUEST)

    Time frame: at 6 weeks

  10. The Quality of life in Essential Tremor (QUEST)

    Time frame: at 12 weeks

  11. The Quality of life in Essential Tremor (QUEST)

    Time frame: at 18 weeks

  12. The Quality of life in Essential Tremor (QUEST)

    Time frame: at 24 weeks

  13. tremor frequency measured by accelerometer

    Time frame: at day 0

  14. tremor frequency measured by accelerometer

    Time frame: at 6 weeks

  15. tremor frequency measured by accelerometer

    Time frame: at 12 weeks

  16. tremor frequency measured by accelerometer

    Time frame: at 18 weeks

  17. tremor frequency measured by accelerometer

    Time frame: at 24 weeks

  18. mean peak amplitude measured by accelerometer

    Time frame: at day 0

  19. mean peak amplitude measured by accelerometer

    Time frame: at 6 weeks

  20. mean peak amplitude measured by accelerometer

    Time frame: at 12 weeks

  21. mean peak amplitude measured by accelerometer

    Time frame: at 18 weeks

  22. mean peak amplitude measured by accelerometer

    Time frame: at 24 weeks

  23. distance traveled measured by accelerometer

    Time frame: at day 0

  24. distance traveled measured by accelerometer

    Time frame: at 6 weeks

  25. distance traveled measured by accelerometer

    Time frame: at 12 weeks

  26. distance traveled measured by accelerometer

    Time frame: at 18 weeks

  27. distance traveled measured by accelerometer

    Time frame: at 24 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Allergan

Registry information

Official study 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

Acronym: Btx-HT

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2015
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.