Phase 2 N=78 Randomized Double-blind Treatment

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

Essential Tremor of the Upper Limb

Bottom Line

View on ClinicalTrials.gov: NCT04766723 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

Apr 2026

Primary outcome: Primary: Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist — -0.25; -0.46 degrees of arc

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NT 201 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merz Pharmaceuticals GmbH
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Unilateral Treatment Period: Change From Baseline to Week 6 in Maximum Tremor Amplitude of the Wrist	-0.25; -0.46	—
SECONDARY Unilateral Treatment Period: Change From Baseline to Week 6 in the Essential Tremor Rating Assessment Scale (TETRAS) Performance Dominant Upper Limb (UL) Score as Assessed by Investigator	-2.3; -0.9	—
SECONDARY Unilateral Treatment Period: Change From Baseline to Week 6 in the TETRAS Activities of Daily Living (ADL) UL Score	-3.7; -3.8	—
SECONDARY Unilateral Treatment Period: Change From Baseline to Week 6 in TETRAS ADL Functional Impact Score	-1.2; -1.3	—
SECONDARY Unilateral Treatment Period: Subject's Global Impression of Change Scale (GICS) Score of Motor-dominant UL at Week 6	0.9; 0.8	—
SECONDARY Unilateral Treatment Period: Investigator's GICS Score of Motor-dominant UL at Week 6	1.2; 0.8	—
SECONDARY Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Dominant UL Score	-2.8	—
SECONDARY Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS Performance Subscale Score	-5.6	—
SECONDARY Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL UL Score	-4.4	—
SECONDARY Bilateral Treatment Period: Change From Cycle 2 Baseline to Week 6 in TETRAS ADL Functional Impact Score	-1.4	—
SECONDARY Percentage of Subjects With At-least One Treatment Related Treatment-emergent Adverse Events (TEAEs)	30.0; 3.7; 30.6	—

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.

Eligibility Criteria

Inclusion Criteria

Score of ≥ 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) of the TETRAS performances scale confirmed by an independent TETRAS expert by means of video assessment.

Exclusion Criteria

History or presence of day-to-day fluctuations in ET which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day and minimal or no tremor on another day.
Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the ET diagnosis and/or assessment of ET in ULs.
Tremor types other than ET

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04766723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.