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COMPLETED 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

NCT04766723 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 78 participants
Start Date 2021-02-24
Est. Completion 2023-11-20
Phase Phase 2

Sponsor

Merz Pharmaceuticals

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04766723

The ClinicalTrials.gov registry entry for NCT04766723 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merz Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04766723 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Other, Washington, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04766723?

The interventions under investigation include: Placebo (DRUG), NT 201 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04766723?

This trial is sponsored by Merz Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial