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Trial record 2 of 14 for:    Tremor | France

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

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ClinicalTrials.gov Identifier: NCT02555982
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : September 22, 2015
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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

Condition or disease Intervention/treatment Phase
Essential Head Tremor Drug: BOTOX ® 200 Unités Drug: Placebo Phase 3

Detailed Description:

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

Number of centers: 13 centers : Clermont-Ferrand, Paris (Fondation Rothschild et APHP), Toulouse, Lyon, Amiens, Bordeaux, Narbonne, Lille, Strasbourg, Nîmes, Marseille, Besançon.

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Tremor

Arm Intervention/treatment
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).

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555982


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Franck DURIF         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Allergan

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02555982     History of Changes
Other Study ID Numbers: CHU-0245
2015-000162-59 ( EudraCT Number )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Essential Head tremor
Botulinum toxin injections
Quality of life
Embarrassment assessment

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs