A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm

Summary

The purpose of this study is to determine whether a single treatment with NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the motor-dominant arm (Unilateral Period). Participants will be assigned to the treatment groups by chance and neither the participants nor the research staff who interact with them will know the allocation. The following treatment cycle will investigate the safety and tolerability of two-sided treatment with NT 201 (botulinum toxin) (Open Label Bilateral Period). All participants will receive NT 201 treatment.

Timeline

Start

2021-02-24

Primary completion

2023-04-26

Completion

2023-11-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Unilateral Treatment Period: NT 201 vs Unilateral Treatment Period: Placebo; Least Square Mean Difference 0.21 (95% CI -0.18 to 0.61) NCT04766723 ↗

Drugs

Indications