MYOBLOC for Spasticity

Recruiting at 8 trial locations

Overseen By Joseph Hull, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Supernus Pharmaceuticals, Inc.

Must not be taking: Aminoglycosides, Curare-like agents

Disqualifiers: Epilepsy, Neuromuscular disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 13 weeks

272 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing MYOBLOC, a medication that helps relax muscles, in adults with stiff muscles in their arms. It works by blocking nerve signals that cause muscle tightness. The study will compare MYOBLOC to another treatment to see how well it works and how safe it is.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you should not use certain medications like aminoglycoside antibiotics or muscle relaxants close to the trial start. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug MYOBLOC for treating spasticity?

The research does not provide direct evidence about MYOBLOC's effectiveness for spasticity, but it mentions the use of botulinum toxin A (a similar type of treatment) in managing spasticity, which suggests that MYOBLOC might also be effective. ^{1 2 3 4 5}

How is the drug MYOBLOC different from other treatments for spasticity?

MYOBLOC is unique because it is a type B botulinum toxin, which affects a different protein in the body compared to the more commonly used type A toxins like Botox. This difference in mechanism may offer an alternative for patients who do not respond well to type A toxins. ^{6 7 8 9 10}

Research Team

Jonathan Rubin, MD, MBA

Principal Investigator

Supernus Pharmaceuticals

Eligibility Criteria

Adults aged 18-80 with upper limb spasticity from stroke, brain injury, or spinal cord injury that happened at least 6 months ago. They must understand the study and consent to participate (or have a representative do so), be able to follow the protocol for a year, and have certain muscle stiffness levels. Excluded are those with severe lung disease, recent drug/alcohol abuse, other medical risks, recent major surgery or botulinum toxin treatment.

Inclusion Criteria

The investigator is willing and able to comply with all requirements of the protocol, including completion of study questionnaires

I have stiffness in at least two of these muscle groups: elbow, wrist, or fingers.

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.

Exclusion Criteria

I have severe joint stiffness in my arm that limits movement.

You are allergic to botulinum toxin type A or B or any ingredients in MYOBLOC.

Presence of a spinal stimulator or intrathecal baclofen pump that has not been turned off within 30 days prior to screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single treatment of MYOBLOC or placebo for upper limb spasticity

13 weeks

Visits at baseline, Weeks 2, 4, 8, and 13

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants receive 5 separate MYOBLOC treatments approximately 13 weeks apart

65 weeks

Treatment Details

Interventions

• MYOBLOC

Trial Overview The trial is testing MYOBLOC's effectiveness and safety in treating adult upper limb spasticity compared to placebo. It's a Phase 2/3 randomized controlled trial with double-blind procedures initially followed by an open-label extension for further safety evaluation.

Participant Groups

Group I: Phase 3; MYOBLOC Experimental Treatment 1 Intervention

MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group II: Phase 2; Low Dose MYOBLOC Experimental Treatment 1 Intervention

Low Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group III: Phase 2; High Dose MYOBLOC Experimental Treatment 1 Intervention

High Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo

Group IV: Phase 2; Placebo Placebo Group 1 Intervention

Volume-matched placebo is a single treatment

Group V: Phase 3; Placebo Placebo Group 1 Intervention

Volume-matched placebo is a single treatment

Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

14,000+

Solstice Neurosciences

Industry Sponsor

Trials

7

Recruited

1,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Toning it down: selecting outcome measures for spasticity management using a modified Delphi approach. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Spasticity management: an overview. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of tendon fractional lengthenings to improve shoulder function in patients with spastic hemiparesis. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Myobloc. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type B (Myobloc). [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Intrathecal baclofen: Its effect on symptoms and activities of daily living in severe spasticity due to spinal cord injuries: A pilot study. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Continuous intrathecal baclofen therapy using an implantable pump system in severe spasticity]. [2013]

10. Austria pubmed.ncbi.nlm.nih.gov

Intrathecal baclofen therapy in patients with severe spasticity. [2019]