A Study to Investigate the Efficacy and Safety of NT201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm
- Conditions
- Essential tremor [ET] of the upper limb [UL]MedDRA version: 21.1Level: PTClassification code 10015496Term: Essential tremorSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-001988-24-PL
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
• Score of = 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent
TETRAS expert by means of video assessment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether a single treatment with administration of NT 201 (botulinum toxin) is superior to placebo (no medicine) for one-sided treatment of essential tremor in the arm (Unilateral Period).;Secondary Objective: Not applicable;Primary end point(s): 1. Change from study baseline to Week 6 in maximum tremor amplitude measurement at wrist level during the unilateral treatment period<br> [Time Frame: From baseline to week 6];Timepoint(s) of evaluation of this end point: From baseline to week 6
- Secondary Outcome Measures
Name Time Method