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Trial of Botulinum Toxin for Isolated or Essential Head Tremor
Ana Marques1, Bruno Pereira1, Marion Simonetta-Moreau1
1From the Department of Neurology, Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Université Clermont-Auvergne, Centre National de la Recherche Scientifique (CNRS), Image Guided Clinical Neurosciences and Connectomics, Institut Pascal (A.M., P.D., F.D., I.R.), and CHU Clermont-Ferrand, Clinical Research Department, Biostatistics Unit (B.P.), Clermont-Ferrand, the Clinical Investigation Center 1436, the Departments of Clinical Pharmacology, Physiology, and Neurosciences, Toulouse NeuroImaging Center, INSERM, University Hospital of Toulouse and University of Toulouse 3 (M.S.-M., O.R.), and Toulouse NeuroImaging Center, Université de Toulouse, INSERM, Université Paul Sabatier (D.A.), Toulouse, Service de Neurologie, CHU Caremeau, Nîmes (G.C., M.D.V.), the Department of Neurology and Movement Disorders, Timone Hospital, Aix-Marseille Université, Marseille (F.F.), Université de Lyon, Université Claude Bernard Lyon 1, Lyon Neuroscience Research Center, INSERM, Unité 1028, CNRS, Unité Mixte de Recherche (UMR) 5292, Neuroplasticity and Neuropathology of Olfactory Perception Team, Service de Neurologie C, Pierre Wertheimer Neurological Hospital, Hospices Civils de Lyon, Lyon (C.L.), the Neurology Department, Avicenne Hospital, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires de Paris-Seine Saint Denis, Sorbonne Paris Nord, Bobigny (B.D.), Centre de Recherche Interdisciplinaire en Biologie, Collège de France, CNRS UMR 7241, INSERM Unité 1050, Université PSL (B.D.), the Neurology Department (A.P.) and Unité Parkinson (S.S.), Rothschild Foundation Hospital, and Sorbonne Université, Institut du Cerveau et de la Moelle, INSERM, CNRS, Assistance Publique-Hôpitaux de Paris, and the Department of Neurology, Hôpital Pitié-Salpêtrière (J.-C.C.), Paris, the Departments of Neurology and Neurosurgery, Expert Center for Parkinson's Disease, EA 4559 Laboratoire de Neurosciences Fonctionnelles et Pathologie, University of Picardy Jules Verne, Amiens University Hospital, Amiens (M.T., D.D.), the University of Lille, Lille Neuroscience and Cognition, Team DVCD, INSERM Unité Mixte de Recherche en Santé 1172, CHU Lille, Department of Medical Pharmacology, Expert Center of Parkinson's Disease, Lille Center of Excellence for Neurodegenerative Disorders, Centers of Excellence in Neurodegeneration, Lille (A.K.), Service de Neurologie, Narbonne Hospital Centre, Narbonne (G.B.-F.), CHU de Bordeaux, Institut des Maladies Neurodégénératives, CNRS, University of Bordeaux, Bordeaux (D. Guehl), the Department of Neurology, University Hospital of Poitiers, INSERM, CHU de Poitiers, University of Poitiers, Centre d'Investigation Clinique 1402, Poitiers (O.C.), the Department of Neuromuscular Diseases and Department of Anatomy, CHRU Besançon, University of Franche-Comté, Besançon (L.T.), Service de Neurologie, Centre Hospitalier Intercommunal Aix-Pertuis, Site d'Aix-en-Provence, Aix-en-Provence (D. Gayraud), and the Department of Neurology, CHU Hautepierre, INSERM Unité 964, CNRS UMR 7104, Illkirch, and Fédération de Médecine Translationnelle de Strasbourg, Université de Strasbourg, Strasbourg (C.T.) - all in France.
Background:
Local injections of botulinum toxin type A have been used to treat essential head tremor but have not been extensively studied in randomized trials.
Methods:
In a multicenter, double-blind, randomized trial, we assigned, in a 1:1 ratio, adult patients with essential or isolated head tremor to receive botulinum toxin type A or placebo. Botulinum toxin or placebo was injected under electromyographic guidance into each splenius capitis muscle on the day of randomization (day 0) and during week 12. The primary outcome was improvement by at least 2 points on the Clinical Global Impression of Change (CGI) scale at week 6 after the second injection (week 18 after randomization). The CGI scale was used to record the patient's assessment of the degree of improvement or worsening of head tremor since baseline; scores range from 3 (very much improved) to -3 (very much worse). Secondary outcomes included changes in tremor characteristics from baseline to weeks 6, 12, and 24.
Results:
A total of 120 patients were enrolled; 3 patients were excluded during screening, and 117 patients were randomly assigned to receive botulinum toxin (62 patients) or placebo (55 patients) and were included in the intention-to-treat analysis. Twelve patients in the botulinum toxin group and 2 patients in the placebo group did not receive injections during week 12. The primary outcome - improvement by at least 2 points on the CGI scale at week 18 - was met by 31% of the patients in the botulinum toxin group as compared with 9% of those in the placebo group (relative risk, 3.37; 95% confidence interval, 1.35 to 8.42; P = 0.009). Analyses of secondary outcomes at 6 and 12 weeks but not at 24 weeks were generally supportive of the primary-outcome analysis. Adverse events occurred in approximately half the patients in the botulinum toxin group and included head and neck pain, posterior cervical weakness, and dysphagia.
Conclusions:
Injection of botulinum toxin into each splenius capitis muscle on day 0 and during week 12 was more effective than placebo in reducing the severity of isolated or essential head tremor at 18 weeks but not at 24 weeks, when the effects of injection might be expected to wane, and was associated with adverse events. (Funded by the French Ministry of Health; Btx-HT ClinicalTrials.gov number, NCT02555982.).
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