A Phase 3, 20-week, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Single Treatment Cycle to Evaluate the Safety and Efficacy of the Study Drug for the Treatment of Spasticity Involving the Muscles of the Elbow and Shoulder in Adult Post-Stroke Patients.
Principal Investigator: Brad Racette, MD
Contact InformationLaura Rundell
WHAT IS THE PURPOSE OF THE STUDY?
The purpose of this research study is to investigate how safe and how well the study drug works in the treatment of adults who have experienced a stroke resulting in spasticity in one of their upper limbs.
WHO IS NEEDED?
To pre-qualify for this study, the participant must:
• Be 18-80 years of age
• Have had a stroke at least 3 months ago
• Have muscle tightness (spasticity) in the shoulder and elbow due to stroke
• Weigh at least 110 pounds
• Additional criteria apply, including prior injection time constraints
WHAT IS INVOLVED IF I PARTICIPATE?
Duration: There are up to 9 office visits over a period of approximately 20 weeks.
Tests/procedures: Physical exams, vital signs, an ECG test to trace heart rhythm, urine tests, blood draws, and questionnaires. The study drug is administered by injections in the shoulder and elbow areas.
Risks: Risks will be discussed with volunteers as part of the informed consent process. Benefits: Participation may help future patients with post-stroke spasticity. Compensation: Volunteers will be compensated for study participation.