Early Baclofen for Spinal Cord Injury

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

55 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Baclofen for spinal cord injury?

Research shows that Baclofen, when administered intrathecally (directly into the spinal fluid), can reduce spasticity (muscle stiffness) and improve balance in patients with spinal cord injuries. Additionally, it has been used effectively to manage spasticity in conditions like multiple sclerosis, suggesting its potential benefits for spinal cord injury patients. ^{1 2 3 4 5}

Is baclofen generally safe for humans?

Baclofen has been used safely in humans for conditions like spasticity, with some patients experiencing side effects that may require dosage adjustments. In studies, it has not been linked to liver or kidney problems, and it may even aid recovery after spinal cord injury. ^{6 7 8 9 10}

How is the drug Baclofen unique for treating spinal cord injury?

Baclofen is unique for treating spinal cord injury because it can be administered intrathecally (directly into the spinal fluid), which allows for targeted relief of spasticity (muscle stiffness) and neuropathic pain (nerve pain) with potentially fewer side effects compared to oral administration. ^{1 3 4 11 12}

What is the purpose of this trial?

The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI. The main questions it aims to answer are : 1. Assess the safety of early baclofen treatment during acute care after SCI. 2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity. The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.

Research Team

Andréane Richard-Denis, M.D., MSC

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Efficacy of intrathecal baclofen bolus on neuropathic pain in patients with spinal cord injury: A protocol for systematic review and meta-analysis. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Effect of the Intrathecal Baclofen Screening Test on the Spatiotemporal Gait Motion Parameters of Patients with Cervical Spinal Cord Injuries Who Exhibited Diffuse Spasticity: A Report of Three Cases. [2020]

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

Intrathecal baclofen in multiple sclerosis and spinal cord injury: complications and long-term dosage evolution. [2013]

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

Intrathecal and Oral Baclofen Use in Adults With Spinal Cord Injury: A Systematic Review of Efficacy in Spasticity Reduction, Functional Changes, Dosing, and Adverse Events. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Baclofen dosage after traumatic spinal cord injury: a multi-decade retrospective analysis. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Baclofen in the treatment of spasticity. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Bacloffen (Lioresal) in the long-term management of spasticity. [2021]

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

A Longitudinal Study of the Neurologic Safety of Acute Baclofen Use After Spinal Cord Injury. [2020]

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

Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. [2022]

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

Occurrence of adverse events in long-term intrathecal baclofen infusion: a 1-year follow-up study of 158 adults. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Examining the effectiveness of intrathecal baclofen on spasticity in individuals with chronic spinal cord injury: a systematic review. [2021]

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

Intrathecal baclofen administration for control of severe spinal spasticity: functional improvement and long-term follow-up. [2019]