- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555982
Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor (Btx-HT)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Aix-en-Provence, France
- Centre Hospitalier Pays D'Aix
-
Amiens, France
- CHU d'Amiens
-
Besançon, France
- Hopital Jean Minjoz
-
Bordeaux, France
- Hopital 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
- Hopital Lariboisiere
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EXPERIMENTAL GROUP
Patients eligible for inclusion will be randomized to one of the two groups:
|
Patients eligible for inclusion will be randomized to one of the two groups:
|
Other: CONTROL GROUP
Patients eligible for inclusion will be randomized to one of the two groups:
|
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
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
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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