Trial - Trial of botulinum toxin

Btx-HT

Problem

Essential tremor

Format

Multicentre, double-blinded, randomised trial

Treatment

Botulinum toxin 75-100IU

Control

Placebo - saline injection

Population

Adult patients with essential or isolated head tremor

Inclusion criteria

Patients with essential head tremor or isolated head tremor, with or without associated limb tremor,10 were eligible for enrollment.
Tremor severe enough to be troublesome defined by a score of ≥2 on the Fahn–Tolosa–Marin Tremor Rating Scale
Patients on oral Rx for head tremor if dose + frequency stable during the month preceding enrollment and remained stbale during the trial
Previous deep—brain stimulation if surgery performed at least 6 months before enrolment

Exclusion criteria

Dystonic head tremor
Head tremor as a component of a cerebellar syndrome
Parkinson’s disease
Patients receiving botox within 4 months prior to randomisation

Follow-up

Trial lasted 24 weeks. No follow-up.

Primary endpoint

Improvement ≥2 points on Clinical Global Impression of Change (CGI) scale at week 6 after the second injection (week 18 after randomization).

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 endpoint(s)

Change in tremor characteristics from baseline to weeks 6, 12, and 24

Adverse outcomes

Details

-

Brief summary

General improvement in head tremor (prespecified as improvement by at least 2 points on the CGI scale at week 18 (primary outcome)) = higher in botulinum toxin group than placebo.
Analyses of secondary outcomes were generally supportive of this finding with respect to reductions in subjective and objective measures of head tremor severity, functional affects, and social embarrassment.
Differences between the trial groups were generally sustained at other time points but not at 24 weeks, a time at which the effect of botulinum toxin injection has typically waned

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