Early Baclofen for Spinal Cord Injury

Not yet recruiting at 1 trial location

Overseen By Pascal Mputu

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Disqualifiers: Non-traumatic SCI, Penetrating tSCI, Moderate brain injury, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether starting baclofen early can improve recovery after a spinal cord injury. Baclofen treats spasticity, which involves involuntary muscle spasms following an injury. The trial compares two groups: one begins baclofen as soon as spasticity appears, while the other follows usual care, starting only when spasticity becomes severe. It targets individuals with a spinal cord injury from blunt trauma, such as a fall or car accident, who experience muscle spasms. Participants must be able to give informed consent and not have other major neurological conditions. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective baclofen can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for baclofen?

Research has shown that baclofen is generally safe and effective for treating muscle stiffness in people with spinal cord injuries. One study found that baclofen reduces muscle stiffness, improving management of this condition.

Another study found that patients taking baclofen experienced greater improvement in nerve function, suggesting it might aid overall recovery after a spinal cord injury. However, like any medication, baclofen can cause side effects, such as drowsiness or dizziness.

Since the FDA has already approved baclofen for treating muscle stiffness in other conditions, extensive safety information is available. This indicates it has been tested and is considered safe for similar uses. However, discussing any concerns with a doctor is always important. ^{1 2 3 4}

Why are researchers enthusiastic about this study treatment?

Most treatments for spinal cord injury-related spasticity are only started once the spasticity becomes severe and problematic. However, baclofen, when administered early at the first signs of spasticity, might offer a more proactive approach. This early intervention could potentially prevent severe symptoms from developing, leading to better management of spasticity. Researchers are excited because this approach could mean more effective control of symptoms and improved outcomes for patients.

What evidence suggests that early baclofen treatment might be effective for spinal cord injury?

Research shows that baclofen effectively treats muscle stiffness in people with spinal cord injuries. Studies have found that oral baclofen can reduce muscle spasms and improve movement. Baclofen relaxes muscles by acting on the spinal cord, enhancing movement and quality of life. In this trial, participants in the early baclofen treatment group will begin oral baclofen at the first sign of acute spasticity. The control group will receive routine care, with baclofen prescribed only when spasticity becomes severe. While baclofen administered directly into the spine is very effective, oral administration also helps with muscle stiffness. Overall, this treatment is well-regarded for improving outcomes in people with spinal cord injuries. ^{5 6 7 8 9}

Who Is on the Research Team?

Andréane Richard-Denis, M.D., MSC

Principal Investigator

CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient willing and able to provide informed consent

My spinal cord injury was caused by a blunt force.

My spinal cord injury is classified between A to D.

Exclusion Criteria

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

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

I have had a moderate or severe brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Care Treatment

Early detection and treatment of acute spasticity with oral baclofen during acute hospitalization

Up to 4 weeks

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of spasticity, mobility, and neurological recovery

6 months

Weekly visits initially, then monthly follow-ups

Long-term Follow-up

Continued monitoring of neurofunctional outcomes and spasticity management

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Baclofen

Trial Overview 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.

How Is the Trial Designed?

Group I: Early Baclofen treatment group Experimental Treatment 1 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 group Experimental Treatment 1 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.

Baclofen is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

Approved in Canada as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

Approved in European Union as Lioresal for:

• Severe spasticity of cerebral or spinal origin
• Multiple sclerosis
• Traumatic brain injury

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

17

Recruited

4,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4066544/

Examining the effectiveness of intrathecal baclofen on ... While intrathecal baclofen has improved function and quality of life among those with chronic SCI, the risk for adverse events is worth considering for those ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S152994302200907X

Acute baclofen administration promotes functional recovery ... Our outcomes revealed that baclofen, a well-known drug used for spasticity management, improves the motor performance after SCI in a pre-clinical animal model.

3. physio-pedia.com physio-pedia.com/Baclofen_in_the_Treatment_of_Spinal_Cord_Injuries

Baclofen in the Treatment of Spinal Cord Injuries The weak permeability to the blood-brain barrier makes baclofen more effective in treating spasticity at the level of the spinal cord. Additionally, baclofen ...

4. medicaljournals.se medicaljournals.se/jrm/content/html/10.2340/16501977-2211

Efficacy and safety of oral baclofen in the management ... In patients with SCI, oral baclofen was shown to improve spasticity and spasms in the majority of patients (23). However, the study in patients ...

5. archives-pmr.org archives-pmr.org/article/S0003-9993(22)00461-0/abstract

Intrathecal and Oral Baclofen Use in Adults With Spinal ... In the studies reviewed, baclofen effectively improved spasticity outcome measures, with increased efficacy through intrathecal administration.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06564714

Early Pharmacological Treatment of Acute Spasticity After ... Assess the safety of early baclofen treatment during acute care after SCI. Compare the neurofunctional outcomes between the early baclofen group ...

7. neurotherapeuticsjournal.org neurotherapeuticsjournal.org/article/S1878-7479(23)01826-3/fulltext

A Longitudinal Study of the Neurologic Safety of Acute ... Baclofen use was associated with higher rates of marked neurologic recovery, even after adjustment for injury severity (HR = 2.1, 95% CI 1.5–3.0 for high dose ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35750207/

Intrathecal and Oral Baclofen Use in Adults With Spinal ... In the studies reviewed, baclofen effectively improved spasticity outcome measures, with increased efficacy through intrathecal administration.

9. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2580125

Full article: Intrathecal baclofen therapy in spinal cord injury Data were collected to assess ITB trial outcomes, referral patterns, dosing trends, and ITB-related complications. Results. Of the 147 patients, ...