Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor
A legfontosabb adatok
- Hol
- Amherst, Atlanta, Aurora, Boca Raton, Boston, Burlington, Centerville, Chapel Hill, Charleston, Dallas, Decatur, Falls Church, Fernandina Beach, Georgetown, Greenfield, Hoover, Houston, Jackson, Jacksonville, Kansas City, Loma Linda, Marshfield, New Albany, Orlando, Overland Park, Philadelphia, Phoenix, Pittsburgh, Port Saint Lucie, Portland, San Antonio, Stamford, Tucson és Winston-Salem (Egyesült Államok)Mind a 36 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Dent Neurologic Institute - Amherst /ID# 255665Amherst, Egyesült ÁllamokNo longer taking part
- Emory University / Emory Brain Health Center /ID# 231911Atlanta, Egyesült ÁllamokNo longer taking part
- University of Colorado - Anschutz Medical Campus /ID# 239869Aurora, Egyesült ÁllamokNo longer taking part
- Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 231677Boca Raton, Egyesült ÁllamokNo longer taking part
- Tufts Medical Center /ID# 239929Boston, Egyesült ÁllamokNo longer taking part
- Lahey Hospital & Medical Center /ID# 233232Burlington, Egyesült ÁllamokNo longer taking part
- Dayton Center for Neurological Disorders /ID# 233737Centerville, Egyesült ÁllamokNo longer taking part
- UNC Hospitals Neurology Clinic - Chapel Hill /ID# 238857Chapel Hill, Egyesült ÁllamokNo longer taking part
- Medical University of South Carolina /ID# 233538Charleston, Egyesült ÁllamokNo longer taking part
- Texas Neurology /ID# 250428Dallas, Egyesült ÁllamokNo longer taking part
- University of Texas Southwestern Medical Center /ID# 239770Dallas, Egyesült ÁllamokNo longer taking part
- Accel Research Site-NeuroStudies /ID# 239881Decatur, Egyesült ÁllamokNo longer taking part
- Integrated Neurology Services - Falls Church /ID# 233545Falls Church, Egyesült ÁllamokNo longer taking part
- Coastal Clinical Research Specialists /ID# 240897Fernandina Beach, Egyesült ÁllamokNo longer taking part
- Texas Movement Disorder Specialists, PLLC /ID# 242524Georgetown, Egyesült ÁllamokNo longer taking part
- Gamma Therapeutic Center /ID# 232547Greenfield, Egyesült ÁllamokNo longer taking part
- Accel Research Sites - Neurology and Neurodiagnostics of Alabama, LLC /ID# 240472Hoover, Egyesült ÁllamokNo longer taking part
- Baylor College of Medicine /ID# 231624Houston, Egyesült ÁllamokNo longer taking part
- Henry Ford Health Medical Center - Jackson /ID# 231400Jackson, Egyesült ÁllamokNo longer taking part
- Coastal Clinical Research Specialists /ID# 240471Jacksonville, Egyesült ÁllamokNo longer taking part
- Univ Kansas Med Ctr /ID# 231166Kansas City, Egyesült ÁllamokNo longer taking part
- Loma Linda University /ID# 230905Loma Linda, Egyesült ÁllamokNo longer taking part
- Marshfield Clinic - Marshfield /ID# 233191Marshfield, Egyesült ÁllamokNo longer taking part
- The Orthopedic Foundation /ID# 232234New Albany, Egyesült ÁllamokNo longer taking part
- Charter Research - Winter Park /ID# 241568Orlando, Egyesült ÁllamokNo longer taking part
- Kansas Institute of Research /ID# 231623Overland Park, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson University Hospital /ID# 232614Philadelphia, Egyesült ÁllamokNo longer taking part
- Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 231731Phoenix, Egyesült ÁllamokNo longer taking part
- University of Pittsburgh MC /ID# 233735Pittsburgh, Egyesült ÁllamokNo longer taking part
- CDC Research Institute LLC /ID# 242744Port Saint Lucie, Egyesült ÁllamokNo longer taking part
- Oregon Health and Science University /ID# 231581Portland, Egyesült ÁllamokNo longer taking part
- Univ Texas HSC San Antonio /ID# 232615San Antonio, Egyesült ÁllamokNo longer taking part
- New England Institute for Clinical Research /ID# 238404Stamford, Egyesült ÁllamokNo longer taking part
- University of Arizona /ID# 239781Tucson, Egyesült ÁllamokNo longer taking part
- Atrium Health Wake Forest Baptist Medical Center /ID# 233550Winston-Salem, Egyesült ÁllamokNo longer taking part
- Neurology - Triad /ID# 239806Winston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- AbbVie
- Azonosító
- NCT05216250
- A regiszteradat frissítve
- 2026. január 20.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: Diagnosis of essential tremor in accordance with modified Tremor Investigation Group (TRIG) criteria as described in the protocol; TREDS-Revised Scale (1-4 scale, whole numbers) unilateral score of >= 3 for the Tremor Disability Scale (TREDS) on any of the 7 unilateral items; no more than a single item score of 1 among the 7 unilateral items in the dominant limb; TETRAS activities of daily living (ADL) (recorded on a 0-4 scale, whole numbers) minimum score of >= 3 on any of the 5 unilateral items; no more than a single item score of <=1 among the 5 unilateral items in the dominant limb; At least one of the following criteria must also be met:; TETRAS UL score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb on at least one of the 3 maneuvers OR; TETRAS Archimedes spiral task score (0-4 scale, with 0.5 increments) of > 2 in the dominant limb.
Kizáró feltételek: Any uncontrolled clinically significant medical condition other than the one under study; Any medical condition that may put the participant at increased risk with exposure to BOTOX Purified Neurotoxin Complex.