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Muscle Relaxant

Early Baclofen for Spinal Cord Injury

Phase 4

Waitlist Available

Led By Andréane Richard-Denis, M.D., MSC

Research Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NLI between C0 and L1

Blunt (non-penetrating) traumatic SCI

Must not have

Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)

Penetrating tSCI (from stab wound, gunshot injury, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from acute care to 6 months after the injury,

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if giving baclofen early to patients with spinal cord injuries can prevent muscle stiffness and improve recovery. They want to see if it is safe and if it helps with movement,

Who is the study for?

This trial is for individuals with acute spinal cord injury who are experiencing early signs of muscle spasms. Participants must be in the initial phase post-injury and have not yet received treatment for spasticity.

What is being tested?

The study compares two approaches: one group receives early intervention with a medication called baclofen at the first sign of muscle spasms, while the control group gets usual care and only receives baclofen when spasms become severe.

What are the potential side effects?

Baclofen may cause drowsiness, weakness, dizziness, headache, seizures, nausea, low blood pressure, constipation or difficulty urinating. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal injury is between my neck and upper back.

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My spinal cord injury was caused by a blunt force.

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My spinal cord injury is classified between A to D.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My spinal cord injury is due to a non-traumatic cause like a tumor or infection.

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My spinal cord injury was caused by a penetrating object like a bullet or knife.

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My spinal injury did not affect my motor or sensory functions upon admission.

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I am able to understand and give consent for my treatment.

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I have a neurological condition like stroke, Parkinson's, or MS.

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My spinal cord injury is at L1 level or lower.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from acute care to 6 months after the injury,

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from acute care to 6 months after the injury,

This trial's timeline: 3 weeks for screening, Varies for treatment, and from acute care to 6 months after the injury, for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Spinal Cord Independence Measure (SCIM)

Secondary study objectives

Functional Assessment and Independent Walking

Muscle Spasticity assessment

Neurological Assessment

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Early Baclofen treatment groupExperimental Treatment1 Intervention

Oral baclofen will be started as soon as any sign of acute spasticity consisting of spasms, velocity-dependent hypertonia and/or clonus is observed. Oral baclofen will be initiated the same day as when signs of spasticity are first observed. Dosage : oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response,

Group II: Control groupExperimental Treatment1 Intervention

The control group will receive the "usual routine care" as per which baclofen is prescribed only when acute spasticity becomes severe and problematic. In the presence of problematic spasticity, oral administration of baclofen is started initially at 5 mg three times a day. The dose is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.

0 / 9Eligibility criteria met