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NCT05216250 · ClinicalTrials.gov registry record · Phase 2
Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
A Phase 2 study of Upper Limb Essential Tremor (UL ET), sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT05216250: Completed Phase 2 study of Upper Limb Essential Tremor (UL ET), sponsored by AbbVie.
NCT05216250 is a Phase 2 study of Upper Limb Essential Tremor (UL ET) that has completed, run by AbbVie. The registered enrollment target is 174 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05216250, a Phase 2 study of Upper Limb Essential Tremor (UL ET), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Tremor Disability Scale-Revised (TREDS-R) is a scale to assess activities of daily living (ADL) through a self-questionnaire asking participants to rate how easy or difficult it is to perform a particular activity. The scale consists of 20 items with each item rated on a scale of 1 (able to do the activity without difficulty) to 4 (cannot do the activity by yourself). 7 items included in this subset will be: use a spoon to drink soup, hold a cup of tea, pour milk from a bottle or carton, dial a
Conditions Studied
Interventions
- BIOLOGICAL BOTOX
- DRUG Placebo for BOTOX
Study Locations (20)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677 - Boca Raton
- Coastal Clinical Research Specialists /ID# 240897 - Fernandina Beach
- Coastal Clinical Research Specialists /ID# 240471 - Jacksonville
- Charter Research - Winter Park /ID# 241568 - Orlando
- CDC Research Institute LLC /ID# 242744 - Port Saint Lucie
Arizona
- Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731 - Phoenix
- University of Arizona /ID# 239781 - Tucson
Georgia
- Emory University / Emory Brain Health Center /ID# 231911 - Atlanta
- Accel Research Site-NeuroStudies /ID# 239881 - Decatur
Kansas
- Univ Kansas Med Ctr /ID# 231166 - Kansas City
- Kansas Institute of Research /ID# 231623 - Overland Park
Massachusetts
- Tufts Medical Center /ID# 239929 - Boston
- Lahey Hospital & Medical Center /ID# 233232 - Burlington
Alabama
- Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472 - Hoover
California
- Loma Linda University /ID# 230905 - Loma Linda
Colorado
- University of Colorado - Anschutz Medical Campus /ID# 239869 - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2022-04-12 |
| Est. Completion | 2025-02-03 |
| Phase | Phase 2 |
What the finished NCT05216250 record still lists
NCT05216250 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher).
The record links to 1 condition, with Upper Limb Essential Tremor (UL ET) appearing as the primary indexed condition, and to 2 interventions - of which BOTOX is the first listed.
NCT05216250 names 20 study sites across 12 states, led by Florida, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT05216250 about?
NCT05216250 is a clinical study titled "Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor". 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 BO...
What is the current status of trial NCT05216250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2022-04-12. Estimated completion is 2025-02-03.
What conditions does trial NCT05216250 study?
This clinical trial studies the following conditions: Upper Limb Essential Tremor (UL ET).
What interventions are being tested in trial NCT05216250?
The interventions under investigation include: BOTOX (BIOLOGICAL), Placebo for BOTOX (DRUG).
Who is sponsoring clinical trial NCT05216250?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05216250 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05216250's enrollment target sits among peer trials
174 396th of 2000 higher than 1,604 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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