Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cerebral Palsy
- Cerebrovascular Accident
- Cervical Spinal Cord Injury
- Multiple Sclerosis
- Spasticity
- Traumatic Brain Injury
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC in the Treatment of Adult Upper Limb Spasticity Followed by an Open-Label Extension, Multiple-Treatment in Safety Study of MYOBLOCMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: No other parties are masked in the clinical trial.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of a single-dose of MYOBLOC over a 1-year duration in adult subjects with upper limb monoplegia or hemiplegia spasticity due to stroke or TBI, followed by an open-label extension safety study of multiple doses...
Multicenter, randomized, double-blind, placebo-controlled study of the safety and efficacy of a single-dose of MYOBLOC over a 1-year duration in adult subjects with upper limb monoplegia or hemiplegia spasticity due to stroke or TBI, followed by an open-label extension safety study of multiple doses. The primary goal is to assess the efficacy of MYOBLOC versus placebo in the treatment of adult upper limb spasticity. The secondary goals are: to establish a safe and efficacious dose of MYOBLOC (administered intramuscularly as a single total dose, to assess the duration of therapeutic response of MYOBLOC after a single administration, and to evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations at 13-week intervals over a minimum duration of 1 year.
Tracking Information
- NCT #
- NCT04815967
- Collaborators
- Not Provided
- Investigators
- Study Chair: Azmi Nasser, PhD Supernus Pharmaceuticals
Get Well Soon