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

Who is this study for? Adult patients with Essential Head Tremor
What treatments are being studied? BOTOX
Status: Completed
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
France
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
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
Time Frame
Start Date: June 27, 2016
Completion Date: September 1, 2022
Participants
Target number of participants: 120
Treatments
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).
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).
Sponsors
Leads: University Hospital, Clermont-Ferrand
Collaborators: Allergan

This content was sourced from clinicaltrials.gov

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