Phase 2 Study of Corabotase Compared to Placebo for Treating Cervical Dystonia in Adults

What this Trial Is About

Researchers are evaluating the study drug Corabotase IPN10200 for treating Cervical Dystonia CD in adults. This condition causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches, possibly related to brain and genetic factors. The study compares Corabotase to a placebo to assess its safety and effectiveness, aiming for a longer-lasting treatment than current botulinum toxin injections. This is a Phase II, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive one of several doses of Corabotase Dose A, Dose B, or possibly Dose C or placebo. The study drug is given by intramuscular injection into different muscles in the head, neck, and shoulders in a single treatment cycle on Day 1 of the treatment period. The study includes a screening period of up to 4 weeks followed by a 36-week treatment period with 10 in-clinic visits and one remote phone visit 12 visits for those receiving Dose C. During the study, participants will undergo physical and neurological exams, blood and urine sample collections, and clinical assessments. They will complete questionnaires to track symptoms and treatment effects. Researchers will measure changes in the Toronto Western Spasmodic Torticollis Rating Scale TWSTRS scores and other pain and disability scales at multiple time points up to week 36. Safety, antibody formation, and adverse events will also be closely monitored. Total participation lasts about 40 weeks.

A Study of IPN10200 for the Treatment of Cervical Dystonia in Adults