Phase 2; Low Dose MYOBLOC for Spinal Cord Injuries

Phase-Based Estimates
1
Effectiveness
2
Safety
Fakultní nemocnice Brno, Neurologická klinika FN Brno (University Hospital Brno, Department of Neurology), Brno, Czechia
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Phase 2; Low Dose MYOBLOC - Drug
Eligibility
18+
All Sexes
Eligible conditions
Spinal Cord Injuries

Study Summary

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

See full description

Eligible Conditions

  • Spinal Cord Injuries
  • Sclerosis
  • Wounds
  • Spastic
  • Stroke
  • Multiple Sclerosis
  • Cerebral Palsy
  • Brain Injuries
  • Brain Injuries, Traumatic
  • Wounds and Injuries
  • Spasticity
  • Muscle Spasticity
  • Cerebrovascular Accident
  • Traumatic Brain Injury (TBI)
  • Cervical Spinal Cord Injury

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Phase 2; Low Dose MYOBLOC will improve 2 primary outcomes and 15 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline and Week 4.

Year 1
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
• To evaluate the long-term safety and tolerability of MYOBLOC after multiple administrations.
Baseline and Week 4
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) Responder Rate for the Primary Target Muscle Group (PTMG) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone of the Primary Target Muscle Group (PTMG) [Phase 2 and Phase 3]
Week 2
Effect of MYOBLOC on the Caregiver Global Impression of Severity (GGI-S) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Clinical Global Impression of Severity (CGI-S) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Patient Global Impression of Severity (PGI-S) [Phase 2 and Phase 3]
Week 2
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone in each muscle group selected for treatment [Phase 2 and Phase 3]
Effect of MYOBLOC on the Modified Ashworth Scale (MAS) for tone in the Primary Target Muscle Group (PTMG) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Modified Barthel Index (MBI) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Pain Numeric Rating Scale (Pain-NRS) [Phase 2 and Phase 3]
One Year
The primary objective of this trial is to assess the efficacy of MYOBLOC versus placebo in the treatment of adult upper limb spasticity.
Week 2
Effect of MYOBLOC on Clinical Global Impression of Change (CGI-C) Scale [Phase 2 and Phase 3]
Effect of MYOBLOC on the Caregiver Global Impression of Change (GGI-C) [Phase 2 and Phase 3]
Effect of MYOBLOC on the Patient Global Impression of Change (PGI-C) [Phase 2 and Phase 3]

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

10 Treatment Groups

Phase 2; Placebo
Phase 3; MYOBLOC
Placebo group

This trial requires 272 total participants across 10 different treatment groups

This trial involves 10 different treatments. Phase 2; Low Dose MYOBLOC is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Phase 3; MYOBLOC
Drug
MYOBLOC is a single treatment and will be compared to volume-matched placebo
Experimental: Phase 2: MYOBLOC 10,000 U, IM
Drug
Phase 2 will compare the efficacy and safety of 2 doses of MYOBLOC versus volume-matched placebo in the treatment of upper limb spasticity. Ninety subjects will be randomized 1:1:1 to receive a total limb dose of 10,000 Units of MYOBLOC, 15,000 U of MYOBLOC. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension.
Experimental: Phase 2: MYOBLOC 15,000 U, IM
Drug
Phase 2 will compare the efficacy and safety of 2 doses of MYOBLOC versus volume-matched placebo in the treatment of upper limb spasticity. Ninety subjects will be randomized 1:1:1 to receive a total limb dose of 10,000 Units of MYOBLOC, 15,000 Units of MYOBLOC. Provided retreatment criteria has been met, subjects will be eligible to participate in open-label extension.
Experimental: Phase 3 -RP3D
Drug
Phase 3 will compare the efficacy and safety of the RP3D of MYOBLOC versus volume-matched placebo in the treatment of upper limb spasticity. Between 60 to 182 subjects will be randomized 1:1 to receive the RP3D of MYOBLOC.
Phase 2; High Dose MYOBLOC
Drug
High Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo
Phase 2; Low Dose MYOBLOC
Drug
Low Dose MYOBLOC is a single treatment and will be compared to volume-matched placebo
Phase 2; Placebo
Drug
Volume-matched placebo is a single treatment
Phase 3; Placebo
Drug
Volume-matched placebo is a single treatment
Placebo Comparator: Phase 2: Placebo
Drug
Volume-matched placebo via intramuscular (IM) injection into targeted muscles of the affected upper limb.
Placebo Comparator: Phase 3: Placebo
Drug
Volume-matched placebo via IM injection into targeted muscles of the affected upper limb.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 13-week intervals over a minimum duration of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 13-week intervals over a minimum duration of 1 year for reporting.

Closest Location

Idaho Physical Medicine and Rehabilitation - Boise, ID

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
The investigator is willing and able to comply with all requirements of the protocol, including completion of study questionnaires show original
You are able to understand the potential risks and benefits, the study requirements, and provide written informed consent before enrollment into the study show original
You are male or female 18 or older. show original
Subjects with upper limb spasticity due to stroke, or traumatic brain injury, or spinal cord injury that occurred ≥ 6 months prior to randomization. show original
You have at least two 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. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes spinal cord injuries?

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Most patients who suffer a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) have multiple causes. While these causes are difficult to find, it is important for patients and their families to have high-quality information regarding prevention and treatments as well as an understanding of risk factors associated with spinal cord injuries.

Unverified Answer

Can spinal cord injuries be cured?

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Although SCI does not affect the basic functions of the human body, the ability to perceive pain disappears in individuals with SCI. Pain perception fades over time in patients with brain-injured individuals, especially with the loss of touch perception in the extremities. Many patients who are in a vegetative state do not perceive pain due to the absence of other sensory nerves from the spinal cord. However, the ability persists and patients perceive pain. Therefore, to prevent and reduce pain, we need to make great efforts to learn about pain perception and to use it to relieve it. Spinal anesthesia is used to alleviate pain in patients with severe neuromuscular disorders.

Unverified Answer

What is spinal cord injuries?

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A person who sustains a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) is often a victim of trauma, where the body's bones were fractured and shattered, or of the pressure of a speeding car. The damage to the spinal cord can often result in mobility loss, and loss of sensation in parts of the body below the level of the point of injury. Most spinal cord injuries come about as a result of a car crash, while the number of spinal cord injuries from assault and unintentional falls are on the rise.\n

Unverified Answer

What are the signs of spinal cord injuries?

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Severe pain and difficulty moving the legs, with signs of a decreased or loss of sensation below the knees, are signs of spinal cord injuries. Any sensation at all is an excellent sign of spinal cord injuries.

Unverified Answer

What are common treatments for spinal cord injuries?

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Sufficient evidence exists to suggest that treatment for spinal cord injury is highly dependent upon the cause and location of the injury. Medication is often used to treat many forms of spinal cord injury, with the intention to reduce pain and spasticity. This is particularly relevant to patients with penetrating trauma or spinal cord injury where immobilization of the spine is necessary. A range of medications and interventions are used for the management of other forms of spinal cord injury. Treatment includes physical therapy, occupational therapists, Speech Language Therapy, and specialized equipment like the L-tube and a wheelchair. Severe cases (such as trauma in the cervical region) are treated to minimize neurological deficits in order to maximize functional recovery and overall independence.

Unverified Answer

How many people get spinal cord injuries a year in the United States?

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The US experiences a considerable number of spinal cord injuries (SCI), with the annual number of people affected estimated to be over 200,000. SCI results from falling, lifting, road traffic, etc., are often the result of a crash, accident, or a natural event. Prevention programs and medical education efforts should focus on preventing people engaging in dangerous behaviors associated with falls and lifting activities from falling, and educating individuals about the risks of such incidents.

Unverified Answer

What are the common side effects of phase 2; high dose myobloc?

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There is evidence that myobloc is well accepted and safe in patients with [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury). Although this is only a phase 2 trial, there are a few side effects of myobloc. They include pain, bruising, and local or general adverse reactions. Myobloc should be used carefully for patients with spinal cord injuries.

Unverified Answer

Has phase 2; high dose myobloc proven to be more effective than a placebo?

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Using a combination of MTX, a myobloc® and a baclofen pump, a high dose of MTX has been shown to be more effective than a placebo in reducing spasticity in a patient diagnosed with spinal cord injury. If long term, baclofen pumps may be a better option than a baclofen pump which is more complicated to use and more expensive.

Unverified Answer

What is the latest research for spinal cord injuries?

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It is imperative that we all gain a better understanding of the many variables in determining outcomes for SCI patients. Many things are unknown about the effect of the time of injury, environment, and type of injury on patient outcomes. It is important to look at this information to determine what interventions need to be put in place when possible. Currently, there are still unanswered questions about the underlying pathomechanisms involved in SCI which makes recovery from injury difficult. To reduce mortality and morbidity resulting from SCI, we must continue to look at the many possible factors surrounding the injury that affect the outcomes of each individual. Data from a recent study from clinical trials and other meta-analyses are crucial for us to look at and must be interpreted on an individual basis.

Unverified Answer

What is the average age someone gets spinal cord injuries?

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The average age of injury for patients who are admitted to a rehabilitation unit is 59 years of age. In contrast, for patients in the hospital, the average is 47 years old. This difference illustrates a more complicated course of treatment for those who suffer spinal cord injuries. Clinicians should keep these factors in mind when assessing patients' potential for recovery.

Unverified Answer

How serious can spinal cord injuries be?

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[SCI can be a devastating and life-crunching injury that can lead to severe disability. Furthermore, SCI is extremely rare and the number of injured patients is small so the treatment is highly complicated and the outcome is extremely difficult] (Habib et al., Spinal Cord injuries: basic and advanced concepts, 2nd ed., 2014, Elsevier Publishing Group Inc., pp. 10–14).

Unverified Answer

Does spinal cord injuries run in families?

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The likelihood of acquiring a SCI is not linked to the presence or absence of a prior affected family member. The authors discuss the importance of considering the genetic basis of susceptibility to SCI when planning prevention strategies.

Unverified Answer
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