Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phase 2; Low Dose MYOBLOC · 1 trial · 6 indications
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 ...
MYOBLOC is being studied for the treatment of adult upper limb spasticity. It is an investigational small molecule in Phase 2 clinical development. The drug is evaluated in a placebo-controlled trial for patients with spasticity due to conditions such as cerebrovascular accident, multiple sclerosis, traumatic brain injury, cervical spinal cord injury, and cerebral palsy.
MYOBLOC is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting a Phase 2 clinical trial to evaluate the efficacy and safety of MYOBLOC for the treatment of adult upper limb spasticity.
MYOBLOC is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 study is active but not recruiting participants, and it is designed to assess the efficacy and safety of MYOBLOC in treating adult upper limb spasticity.
MYOBLOC is being studied in a Phase 2 clinical trial registered as NCT04815967, titled 'Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity.' The trial is active but not recruiting, with an enrollment of 272 participants. It is a randomized, double-blind, placebo-controlled study conducted in the United States and Czechia.
MYOBLOC is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of adult upper limb spasticity. The drug is being evaluated in a clinical trial to determine its efficacy and safety, but it has not yet received regulatory approval.