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Phase 2; Low Dose MYOBLOC

Phase 2

Spasticity | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: Mar 7, 2023

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment272
FDA Designations
No designations recorded
Clinical trial landscape

Phase 2; Low Dose MYOBLOC · 1 trial · 6 indications

Phase 2 1
NCT04815967Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb SpasticitySpasticity
ACTIVE NOT_RECRUITING272 Analytics
PHASE2ACTIVE NOT_RECRUITING
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity
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Study Endpoints
Primary Endpoints
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone of the Primary Target Muscle Group (PTMG) [Phase 2 and Phase 3]
Baseline and Week 4

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.

Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) Scale [Phase 2 and Phase 3]
Week 4

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.

Secondary Endpoints
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone in each muscle group selected for treatment [Phase 2 and Phase 3]
Baseline and Week 4
Effect of MYOBLOC on the Patient Global Impression of Change (PGI-C) [Phase 2 and Phase 3]
Week 4
Effect of MYOBLOC on the Caregiver Global Impression of Change (GGI-C) [Phase 2 and Phase 3]
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 2; Low Dose MYOBLOCEXPERIMENTALLow Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo
Phase 2; High Dose MYOBLOCEXPERIMENTALHigh Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo
Phase 2; PlaceboPLACEBO_COMPARATORVolume-matched placebo is a single treatment
Phase 3; MYOBLOCEXPERIMENTALMYOBLOC is a single treatment and will be compared to volume-matched placebo
Phase 3; PlaceboPLACEBO_COMPARATORVolume-matched placebo is a single treatment
Interventions
NameTypeDescription
Phase 2; Low Dose MYOBLOCDRUGIntramuscular injections on Day 1
Phase 2; High Dose MYOBLOCDRUGIntramuscular injections on Day 1
Phase 2; PlaceboDRUGIntramuscular injections on Day 1
Phase 3; MYOBLOCDRUGIntramuscular injections on Day 1
Phase 3; PlaceboDRUGIntramuscular injections on Day 1
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites9

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 ...

Countries:United StatesCzechia
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