Upper Limb Spasticity MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
Conditions
Sponsors
Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for participation, subjects with limb spasticity must meet all of the following criteria: 1. Able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study; or if unable, the subject’s Legally Authorized Representative (LAR) may provide written informed consent. 2. Male or female =18 to maximum of 80 years of age, inclusive 3. Upper limb spasticity due to stroke, or traumatic brain injury, or spinal cord injury that occurred = 6 months prior to randomization. Eligible subjects may have upper limb monoplegia or hemiplegia. Subjects with cerebral palsy are eligible for study enrollment. 4. Modified Ashworth Scale (MAS) scores of =2 in at least two muscle groups inclusive of the elbow, wrist, and finger flexors at screening and baseline. 5. In the Investigator’s opinion, the subject will be available and able to comply with the study requirements for at least 1 year, based on the subject’s overall health and disease prognosis. 6. In the Investigator’s opinion, the subject will be willing and able to comply with all requirements of the protocol, including completion of study questionnaires. A caregiver may be designated to assist with the physical completion of questionnaires/scales. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 232
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be allowed to participate: 1. Quadriplegia/tetraplegia, or triplegia with both upper limbs affected. 2. Uncontrolled epilepsy or any type of seizure disorder with a seizure(s) within the previous year. 3. Neuromuscular disorders including, but not limited to, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), multiple sclerosis (MS), myasthenia gravis, or muscular dystrophy. 4. History of major joint contracture(s), in which, based on the Investigator’s assessment, the contracture(s) significantly contributes to joint immobility in the affected upper limb. 5. Unresolved fracture(s) in the affected upper limb. 6. Severe atrophy in the affected upper limb. 7. Known hypersensitivity to botulinum toxins type A or B or to any MYOBLOC solution components. 8. Concomitant use or exposure within 5 half-lives of randomization of the following: aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function. 9. Treatment with a neurolytic agent (e.g., phenol, alcohol blocks) to the affected upper limb within 1 year before randomization. 10. Presence of a spinal stimulator or intrathecal baclofen pump that has not been turned off within 30 days prior to screening. 11. Changes to treatment regimen or any new treatment with oral antispasmodics and/or muscle relaxants within 30 days prior to randomization. 12. Initiation of physical and/or occupational therapy 1.5 times the upper limit of normal (ULN); - Serum total bilirubin > 1.5 times ULN; - Serum alanine aminotransferase or aspartate aminotransferase >2 times ULN. 17. Has any of the following cardiac findings at screening: - Abnormal ECG that is, in Investigator’s opinion/evaluation, clinically significant; - PR interval >220 ms; - QRS interval >130 ms; - QTcF interval >450 ms (for men), or >470 ms (for women) (QT corrected using Fridericia’s method); - Second-or third-degree atrioventricular block; - Any rhythm, other than sinus rhythm, that is interpreted or assessed by the Investigator to be clinically significant. Please refer to Protocol for full list of exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess the efficacy of MYOBLOC versus placebo in the treatment of adult upper limb spasticity.;Secondary Objective: The secondary objectives of this trial are: • To establish a dose response between 2 active doses of MYOBLOC versus placebo. • To assess the duration of therapeutic response after a single administration of MYOBLOC. • To evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations at approximately 13-week intervals over a minimum duration of 1 year.;Primary end point(s): Co-Primary Efficacy Endpoints Phase 2 and Phase 3 of the Double-Blind Period • Change from baseline in tone of the PTMG selected for treatment as measured by the MAS at Week 4 post-injection. • Clinical Global Impression of Change (CGI-C) in functional ability at Week 4 post-injection.;Timepoint(s) of evaluation of this end point: Week 4 post-injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 2 and Phase 3 of the Double-Blind Period Change from baseline at Week 4 post-injection in: • Tone in each muscle group selected for treatment as measured by the MAS • Patient Global Impression of Change (PGI-C) • Caregiver Global Impression of Change (GGI-C) • Pain Numeric Rating Scale (Pain-NRS) • Modified Barthel Index (MBI) • Responder rate, defined as the percent of subjects with =1 grade reduction in their MAS score compared to their baseline score at Week 4 in the PTMG Change from baseline at Weeks 2, 8, and 13 and if applicable, at reevaluation visits in: • Tone in the PTMG as measured by the MAS • Tone in each muscle group selected for treatment as measured by the MAS • Duration of response by measuring the time elapsed between the injection and relapse of spasticity (MAS =2) • CGI-C and Clinical Global Impression of Severity (CGI-S) • PGI-C and Patient Global Impression of Severity (PGI-S) • GGI-C and Caregiver Global Impression of Severity (GGI-S) • Pain-NRS • MBI (Week 2, Week 8, and end visit of the DBP only) Open-Label Extension • Duration of response by measuring the time elapsed between the injection and relapse of spasticity (MAS =2);Timepoint(s) of evaluation of this end point: Please refer to response in Q E.5.2 for timepoints | — |
Countries
Czechia, Hungary, Poland, Russian Federation, United States
Contacts
Public ContactTami Martin
Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Outcome results
None listed