Cervical Dystonia Clinical Trial
Official title:
An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Repeat Intramuscular ABP-450 (prabotulinumtoxinA) Injection for the Treatment of Cervical Dystonia
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) and Phase 3 (ABP-19001) trials and 29 sites in Europe from Phase 3 (ABP-19001) trial. Study subjects who had their initial dose of study drug in Phase 2 or Phase 3 trial studies, irrespective of treatment allocation, will be eligible to enroll in this OLE study.
This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) and Phase 3 (ABP-19001) trials and 29 sites in Europe from Phase 3 (ABP-19001) trial. Study subjects who had their initial dose of study drug in Phase 2 or Phase 3 trial studies, irrespective of treatment allocation, will be eligible to enroll in this OLE study. Study subjects will receive a predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's discretion and clinical judgment. ;
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