Early Baclofen for Spinal Cord Injury
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.1234Why 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.56789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acute Care Treatment
Early detection and treatment of acute spasticity with oral baclofen during acute hospitalization
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of spasticity, mobility, and neurological recovery
Long-term Follow-up
Continued monitoring of neurofunctional outcomes and spasticity management
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?
2
Treatment groups
Experimental Treatment
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,
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:
- Severe spasticity of cerebral or spinal origin
- Multiple sclerosis
- Traumatic brain injury
- Severe spasticity of cerebral or spinal origin
- Multiple sclerosis
- Traumatic brain injury
- Severe spasticity of cerebral or spinal origin
- Multiple sclerosis
- Traumatic brain injury
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor
Citations
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 ...
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.
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 ...
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 ...
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.
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 ...
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 ...
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.
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, ...
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