Botulinum Toxin A to Treat Arm Tremor

Summary

The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.

Timeline

Start

2014-12-05

Primary completion

2016-05-09

Completion

2016-09-26

Outcome

Missed primary endpoint

registry analysis (superiority test); IncobotulinumtoxinA 30 to 200 U vs Placebo; p = 0.144; LS mean difference -0.43 (95% CI -1.02 to 0.16); ANCOVA NCT02207946 ↗

Publications

• Results Jog M, Lee J, Scheschonka A, Chen R, Ismail F, Boulias C, Hobson D, King D, Althaus M, Simon O, Dersch H, Frucht S, Simpson DM. Tolerability and Efficacy of Customized IncobotulinumtoxinA Injections for Essential Tremor: A Randomized, Double-Blind, Placebo-Controlled Study. Toxins (Basel). 2020 Dec 20;12(12):807. doi: 10.3390/toxins12120807.

Drugs

Indications