Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
Public ClinicalTrials.gov record NCT05216250. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating, and patients also experience associated social embarrassment. This study will assess how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease activity will be evaluated. BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174 participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in North America. Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3, participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05216250
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 174 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2022 (Actual)
- Primary completion
- Feb 3, 2025 (Actual)
- Completion
- Feb 3, 2025 (Actual)
- Last update posted
- Jan 20, 2026
2022 – 2025
United States locations
- U.S. sites
- 36
- U.S. states
- 19
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472 | Hoover | Alabama | 35244-5700 | — |
| Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731 | Phoenix | Arizona | 85013 | — |
| University of Arizona /ID# 239781 | Tucson | Arizona | 85724 | — |
| Loma Linda University /ID# 230905 | Loma Linda | California | 92354 | — |
| University of Colorado - Anschutz Medical Campus /ID# 239869 | Aurora | Colorado | 80045-2527 | — |
| New England Institute for Clinical Research /ID# 238404 | Stamford | Connecticut | 06905 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677 | Boca Raton | Florida | 33486 | — |
| Coastal Clinical Research Specialists /ID# 240897 | Fernandina Beach | Florida | 32034-4779 | — |
| Coastal Clinical Research Specialists /ID# 240471 | Jacksonville | Florida | 32205-8275 | — |
| Charter Research - Winter Park /ID# 241568 | Orlando | Florida | 32803-1839 | — |
| CDC Research Institute LLC /ID# 242744 | Port Saint Lucie | Florida | 34952-7539 | — |
| Emory University / Emory Brain Health Center /ID# 231911 | Atlanta | Georgia | 30329-2206 | — |
| Accel Research Site-NeuroStudies /ID# 239881 | Decatur | Georgia | 30030-2627 | — |
| Univ Kansas Med Ctr /ID# 231166 | Kansas City | Kansas | 66160 | — |
| Kansas Institute of Research /ID# 231623 | Overland Park | Kansas | 66211-1363 | — |
| Tufts Medical Center /ID# 239929 | Boston | Massachusetts | 02111-1552 | — |
| Lahey Hospital & Medical Center /ID# 233232 | Burlington | Massachusetts | 01805 | — |
| Henry Ford Health Medical Center - Jackson /ID# 231400 | Jackson | Michigan | 49201-1852 | — |
| Dent Neurologic Institute - Amherst /ID# 255665 | Amherst | New York | 14226 | — |
| UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857 | Chapel Hill | North Carolina | 27517-4400 | — |
| Neurology - Triad /ID# 239806 | Winston-Salem | North Carolina | 27103-6984 | — |
| Atrium Health Wake Forest Baptist Medical Center /ID# 233550 | Winston-Salem | North Carolina | 27157-0001 | — |
| Dayton Center for Neurological Disorders /ID# 233737 | Centerville | Ohio | 45459-3811 | — |
| The Orthopedic Foundation /ID# 232234 | New Albany | Ohio | 43054-8167 | — |
| Oregon Health and Science University /ID# 231581 | Portland | Oregon | 97239 | — |
| Thomas Jefferson University Hospital /ID# 232614 | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh MC /ID# 233735 | Pittsburgh | Pennsylvania | 15260 | — |
| Medical University of South Carolina /ID# 233538 | Charleston | South Carolina | 29425 | — |
| Texas Neurology /ID# 250428 | Dallas | Texas | 75214 | — |
| University of Texas Southwestern Medical Center /ID# 239770 | Dallas | Texas | 75390-7208 | — |
| Texas Movement Disorder Specialists, PLLC /ID# 242524 | Georgetown | Texas | 78628-4126 | — |
| Baylor College of Medicine /ID# 231624 | Houston | Texas | 77030 | — |
| Univ Texas HSC San Antonio /ID# 232615 | San Antonio | Texas | 78229-3901 | — |
| Integrated Neurology Services - Falls Church /ID# 233545 | Falls Church | Virginia | 22043-2367 | — |
| Gamma Therapeutic Center /ID# 232547 | Greenfield | Wisconsin | 53228-1321 | — |
| Marshfield Clinic - Marshfield /ID# 233191 | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05216250, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 20, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05216250 live on ClinicalTrials.gov.