[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07673107":3,"trial-entities:NCT07673107":108,"trial-summary:NCT07673107":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":45,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":68,"locations":71,"central_contacts":96,"overall_officials":102,"references":106,"see_also_links":107},"NCT07673107","M25-850","Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor","A Phase 2b Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Treatment of Upper Limb Essential Tremor in Adults","RECRUITING","2028-11","2026-06","2026-06-29","2026-06-18","AbbVie","INDUSTRY",true,"Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and\u002For kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and eating. This study will assess if AGN-151607-DP is safe and effective by assessing adverse events and change in disease activity in adult participants with UL ET.\n\nAGN-151607-DP is an investigational drug being developed to treat UL ET. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 94 adult participants with upper limb essential tremor will be enrolled in approximately 40 sites in the United States\u002FCanada.\n\nParticipants will receive intramuscular injections of AGN-151607-DP or matching placebo. Duration of the study is approximately 72 weeks.\n\nThe effect of the treatment will be checked by completion of questionnaires and side effects will be monitored by medical assessments.",null,[19],"Upper Limb Essential Tremor",[19,21],"AGN-151607-DP","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},94,"ESTIMATED",[30,34],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Intramuscular Injection",[21],{"type":31,"name":35,"description":32,"armGroupLabels":36},"Placebo for AGN-151607-DP",[35],[38,42],{"measure":39,"description":40,"timeFrame":41},"Change From Baseline in The Essential Tremor Rating Assessment Scale (TETRAS)","TETRAS assesses participants' ability to function. Items are rated on a 5-category response scale from 0 (no tremor) to 4 (severe tremor).","72 weeks",{"measure":43,"description":44,"timeFrame":41},"Number of Participants with Adverse Events (AEs)","An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.",[46,49],{"measure":47,"description":48,"timeFrame":41},"Change From Baseline in The Essential Tremor Rating Assessment Scale - Upper Limb (TETRAS-UL)","TETRAS Upper Limb (UL) Scale is an item of the TETRAS performance subscale that is designed to assess upper limb tremor. Items are scored from 0 to 4, with 0 indicating no tremor and 4 indicating a severe tremor.",{"measure":50,"description":51,"timeFrame":41},"Change From Baseline in Clinical Global Impression of Severity (CGIS)","CGI-S is a single item used to measure the clinician's impression of the current severity of the patient's essential tremor. The measure uses a 5-point rating scale with scores ranging none to very severe.","ALL","18 Years","85 Years",false,{"inclusion":57,"exclusion":64,"raw_text":67},[58,59,60,61,62,63],"Minimum body weight of 50 kg (110 pounds) at Screening.","Diagnosis of essential tremor (ET) in accordance with the modified Tremor Research Investigation Group (TRIG) criteria, as follows:","Bilateral postural tremor with or without kinetic tremor, involving hands and forearms","Tremor of other body parts may or may not be present in addition to upper limb (UL) tremor","Bilateral tremor may or may not be asymmetric","Tremor that is reported by the participant to be persistent, although the amplitude may fluctuate.",[65,66],"History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular junctional disorders.","History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and\u002For other botulinum toxins.","Inclusion Criteria:\n\n* Minimum body weight of 50 kg (110 pounds) at Screening.\n* Diagnosis of essential tremor (ET) in accordance with the modified Tremor Research Investigation Group (TRIG) criteria, as follows:\n\n  * Bilateral postural tremor with or without kinetic tremor, involving hands and forearms\n  * Tremor of other body parts may or may not be present in addition to upper limb (UL) tremor\n  * Bilateral tremor may or may not be asymmetric\n  * Tremor that is reported by the participant to be persistent, although the amplitude may fluctuate.\n\nExclusion Criteria:\n\n* History of any medical condition that may put the participant at increased risk with exposure to purified botulinum toxin type A complex, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease that might interfere with neuromuscular junctional disorders.\n* History of an allergic reaction to or significant sensitivity to AGN-151607-DP or its excipients and\u002For other botulinum toxins.",[69,70],"ADULT","OLDER_ADULT",[72,81,89],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Neuro Pain Research Center \u002FID# 277899","Fresno","California","93710","United States",{"lat":79,"lon":80},36.74773,-119.77237,{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"Parkinson'S Disease & Movement Disorders Center Of Boca Raton \u002FID# 277079","Boca Raton","Florida","33486",{"lat":87,"lon":88},26.35869,-80.0831,{"facility":90,"status":8,"city":91,"state":84,"zip":92,"country":77,"geoPoint":93},"Charter Research - Winter Park \u002FID# 277875","Orlando","32803-1839",{"lat":94,"lon":95},28.53834,-81.37924,[97],{"name":98,"role":99,"phone":100,"email":101},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[103],{"name":104,"affiliation":13,"role":105},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[19],[],{"nct_id":4,"found":15,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study where participants are randomly assigned to receive either AGN-151607-DP or a placebo. Approximately 94 adult participants will be enrolled.","completed","Study of AGN-151607-DP for Upper Limb Essential Tremor","This study is testing an investigational drug called AGN-151607-DP for adults with upper limb essential tremor (UL ET). UL ET is a movement disorder that causes shaking in the hands and forearms, making everyday tasks difficult. Researchers want to see if AGN-151607-DP is safe and if it can improve tremor symptoms. You could be eligible if you are between 18 and 85 years old, weigh at least 110 pounds, and have been diagnosed with UL ET. Participants will receive either AGN-151607-DP or a placebo (an inactive substance) through intramuscular injections. The study will measure changes in your tremor using a special scale and track any side effects over 72 weeks. Approximately 94 adults will participate across sites in the US and Canada.","Participants will be followed for changes in tremor and adverse events for 72 weeks.",122,"Participants will receive intramuscular injections of either AGN-151607-DP or a placebo. The study will measure changes in tremor and adverse events over 72 weeks.","Not stated in the trial record.",[21],"v2"]