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

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 27, 2016

Primary Completion Date

September 17, 2021

Study Completion Date

September 1, 2022

Conditions
Essential Head Tremor
Interventions
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)."

DRUG

Placebo

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

Trial Locations (17)

63003

CHU de Clermont-Ferrand, Clermont-Ferrand

Unknown

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

CHU d'Amiens, Amiens

Hôpital Jean Minjoz, Besançon

Hôpital Haut-Levêque, Bordeaux

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

University Hospital, Clermont-Ferrand

OTHER