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NCT04766723 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Essential Tremor of the Upper Limb, sponsored by Merz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 14
- Study locations
NCT04766723: Completed Phase 2 study of Essential Tremor of the Upper Limb, sponsored by Merz Pharmaceuticals.
NCT04766723 is a Phase 2 study of Essential Tremor of the Upper Limb that has completed, run by Merz Pharmaceuticals. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04766723, a Phase 2 study of Essential Tremor of the Upper Limb, has completed, sponsored by Merz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 14
- Study locations
Study Summary
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). 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 Bliaterial Period). All participants will receive NT 201 treatment.
Primary Outcome
TremorTek kinematic analytic investigational device is combination of computer software and wearable movement sensors that allows to collect motion data when placed on individual's arm to quantify tremor in various muscle groups that impact shoulder, elbow, wrist. This assessment system was used to measure maximum angular tremor amplitude at wrist of injected limb (unit: degrees). Angular tremor amplitude was measure of tremor severity. Reduction of maximum angular tremor amplitude at wrist of i
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NT 201
Study Locations (14)
Other
- Specjalistyczne Gabinety, Merz Investigational Site #0480059 - Krakow
- NeuroKlinika Gabinet Lekarski, Merz Investigational Site #0480101 - Lodz
- Instytut Zdrowia Dr. Boczarska-Jedynak - Oświęcim
- Mazowiecki Szpital Bródnowski, Merz Investigational Site #0480064 - Warsaw
Washington
- UW Medical Center - Montlake, Merz Investigational Site #0010450 - Seattle
- Selkirk Neurology, Merz Investigational Site #0010456 - Spokane
Florida
- USF, Department of Neurology, Merz Investigational Site #0010020 - Tampa
Nebraska
- University of Nebraska Medical Center, Merz Investigational Site #0010269 - Omaha
Nevada
- Cleveland Clinic Lou Ruvo Center for Brain Health, Merz Investigational Site #0010457 - Las Vegas
New York
- Mount Sinai Medical Center, Merz Investigational Site #0010191 - New York
Tennessee
- Vanderbilt University Medical Center, Neuroscience Institute, Merz Investigational Site #0010206 - Nashville
Texas
- Houston Methodist Neurological Institute, Merz Investigational Site #0010226 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2023-11-20 |
| Phase | Phase 2 |
What the finished NCT04766723 record still lists
NCT04766723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Essential Tremor of the Upper Limb appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04766723 lists 14 locations in 10 states (Other, Washington, Florida).
Frequently Asked Questions
What is clinical trial NCT04766723 about?
NCT04766723 is a clinical study titled "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". 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). Participants will be assigned to the treatment groups by chance and ne...
What is the current status of trial NCT04766723?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2021-02-24. Estimated completion is 2023-11-20.
What conditions does trial NCT04766723 study?
This clinical trial studies the following conditions: Essential Tremor of the Upper Limb.
What interventions are being tested in trial NCT04766723?
The interventions under investigation include: Placebo (DRUG), NT 201 (DRUG).
Who is sponsoring clinical trial NCT04766723?
This trial is sponsored by Merz Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04766723 being conducted?
This trial has 14 study locations across Florida, Nebraska, Nevada, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04766723's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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