Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04815967 | Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity | PHASE2 | ACTIVE NOT_RECRUITING | 272 | — | — | Nov 16, 2021 | Jul 1, 2024 | Mar 7, 2023 | 9 | United States, Czechia |
The first co-primary endpoint is the change from baseline in Modified Ashworth Scale (MAS) score for tone of the Primary Target Muscle Group (PTMG) selected for treatment at Week 4 post-injection. The MAS is an internationally accepted and validated instrument used to measure resistance during passive soft-tissue stretching. Resistance will be measured and recorded using a 6-point scale ranging from 0 (no increase in muscle tone) to 4 (affected part\[s\] rigid in flexion or extension). A lower change from baseline MAS score (\<0) represents a better outcome.
The second co-primary endpoint is the Clinical Global Impression of Change (CGI-C) score in functional ability at Week 4 post-injection. The CGI-C scale is a single item clinician assessment of how much the patient's functional ability has improved, worsened or has not changed relative to the patient's baseline state prior to treatment (injection). The CGI-C is rated on a 7-point Likert scale from 1 to 7, where 1 = "Very much improved", 2 = "Much improved", 3 = "Minimally improved", 4 = "No change", 5 = "Minimally worse", 6 = "Much worse", and 7 = "Very much worse". Successful therapy is indicated by a lower score (\<4) in subsequent testing.
| Arm | Type | Description |
|---|---|---|
| Phase 2; Low Dose MYOBLOC | EXPERIMENTAL | Low Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 2; High Dose MYOBLOC | EXPERIMENTAL | High Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 2; Placebo | PLACEBO_COMPARATOR | Volume-matched placebo is a single treatment |
| Phase 3; MYOBLOC | EXPERIMENTAL | MYOBLOC is a single treatment and will be compared to volume-matched placebo |
| Phase 3; Placebo | PLACEBO_COMPARATOR | Volume-matched placebo is a single treatment |
| Name | Type | Description |
|---|---|---|
| Phase 2; Low Dose MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 2; High Dose MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 2; Placebo | DRUG | Intramuscular injections on Day 1 |
| Phase 3; MYOBLOC | DRUG | Intramuscular injections on Day 1 |
| Phase 3; Placebo | DRUG | Intramuscular injections on Day 1 |
INCLUSION 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 ...