Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 20 study locations across 12 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05216250
The ClinicalTrials.gov registry entry for NCT05216250 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.