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Comparison of Pregabalin and Baclofen Treatment in Patients with Spastic Motor Behavior Following Cervical or Thoracic Spinal Cord Injury

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating spastic motor behavior in patients who have experienced a spinal cord injury. Spastic motor behavior is a condition where muscles become stiff and can have uncontrolled movements, making daily activities difficult. The study compares two medications: Pregabalin and Baclofen, which are both used to help reduce muscle stiffness and spasms.

The purpose of this research is to determine if Pregabalin works better than Baclofen in treating patients who have sudden, dynamic muscle spasms following spinal cord injury. The medications will be given as white capsules taken by mouth. Patients will receive either Pregabalin (up to 600 mg per day) or Baclofen (up to 100 mg per day) for a period of 30 days.

During the study, healthcare providers will monitor how well the medications control muscle spasms and stiffness. They will also assess how the treatments affect the patients' ability to perform daily activities and their overall quality of life. To ensure reliable results, neither the patients nor their healthcare providers will know which medication is being given.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and group assignment
After joining the study, you will be randomly assigned to receive either pregabalin or baclofen
Your spasticity (muscle stiffness) will be evaluated using specific assessment scales
Your current ability to perform daily activities will be measured using standardized tests
Step 2
Medication administration
You will receive either Pregabalin Sandoz 50 mg capsules or Baclofen 10 mg tablets to take by mouth
The treatment period will last for 30 days
Neither you nor your healthcare provider will know which medication you are receiving
Step 3
Daily monitoring
Your muscle stiffness will be measured daily using specific assessment scales
Any changes in your ability to move and control your muscles will be recorded
Your ability to perform daily activities will be regularly assessed
Step 4
Quality of life assessment
You will complete questionnaires about your quality of life
Your independence in daily activities will be evaluated using a specific measurement tool
Your ability to perform specific tasks will be assessed
Step 5
Final evaluation
After 30 days, a final assessment of your muscle stiffness will be conducted
Your overall progress and response to the medication will be evaluated
The final quality of life and independence measurements will be performed

Who can join the trial?

8 criteria

Patient must be between 18 and 75 years old
Patient must have a spinal cord injury that is: - Located in the cervical or thoracic area (neck to upper back region, specifically from C4 to T10 level) - Occurred within the last 2-40 days - Either complete or incomplete (classified as AIS A-C) - Showing severe muscle spasticity (involuntary muscle tightness and stiffness)
Patient must have a high level of muscle spasticity (scoring 3 or higher on specific measurement scales) for at least 3 out of 5 days
Patient must be willing and able to participate in the study activities
Patient must provide written informed consent (or oral consent with a witness signature if unable to write)
Patient must be clinically stable with normal blood pressure and heart function
Patient must not have other serious health conditions that could affect muscle spasticity (such as severe infections or recent surgeries)
If able to have children, patient must agree to use effective birth control methods (such as hormonal contraception, IUD, or abstinence) during the study and for one month after the last dose of study medication

Who cannot join the trial?

13 criteria

Age below 18 or above 65 years
Known hypersensitivity (allergic reaction) to Pregabalin or Baclofen
Presence of pressure ulcers (open wounds caused by prolonged pressure)
Severe liver or kidney dysfunction
Current diagnosis of major depression or other severe psychiatric conditions
Pregnancy or breastfeeding
Spinal cord injury outside the C4-T10 region (injury not located in specified cervical or thoracic spine area)
Previous treatment with Pregabalin or Baclofen in the past 30 days
Participation in other clinical trials within the past 3 months
Presence of other neurological conditions that could affect spasticity
Uncontrolled medical conditions such as high blood pressure or diabetes
History of substance abuse within the past year
Inability to follow study procedures or provide informed consent

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Fakultni nemocnice Motol a Homolka
Prague, Czechia

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Investigated drugs

Pregabalin
is a medication commonly used to treat nerve pain and epilepsy. In this trial, it is being studied for its potential effectiveness in treating muscle spasticity (sudden, uncontrolled muscle movements) in patients who have suffered spinal cord injuries. It works by calming overactive nerves in the body.
Baclofen
is a muscle relaxant that is commonly used to treat muscle spasms, stiffness, and tightness caused by spinal cord injuries or other neurological conditions. It works by helping to relax the muscles and reduce muscle contractions. In this trial, it serves as a comparison treatment to evaluate which medication works better for patients with spinal cord injury-related muscle spasticity.

What is already known about the treatment

Pregabalin
An anticonvulsant and analgesic medication taken orally in capsule form, which works by binding to calcium channels in the nervous system to reduce the release of excitatory neurotransmitters. It is primarily used to treat neuropathic pain, epilepsy, anxiety disorders, and spastic motor behavior in spinal cord injury patients, particularly those with phasic spasticity. The medication acts by decreasing abnormal electrical activity in the brain and reducing pain signals traveling through the spinal cord and nerves.
Baclofen
A muscle relaxant and antispastic agent administered orally in tablet form, which acts as a GABA-B receptor agonist in the central nervous system. It is commonly prescribed to treat muscle spasms, stiffness, and spastic motor behavior associated with spinal cord injuries, multiple sclerosis, and other neurological conditions. The medication works by helping to relax tense, stiff muscles and reduce muscle pain and discomfort by decreasing the transmission of signals between the spinal cord and muscles.

Investigated diseases

Spinal Cord Injury (SCI)
A condition that occurs when the spinal cord is damaged, disrupting communication between the brain and parts of the body below the injury site. The injury can be complete (total loss of sensation and movement below injury level) or incomplete (some function remains). In cervical and thoracic injuries (C4-T10), the condition affects the upper body, trunk, and lower extremities. After SCI, patients often develop spastic motor behavior, where muscles become stiff and exhibit uncontrolled movements. Spasticity typically develops in the sub-acute phase, which occurs weeks to months after the initial injury.
Spastic Motor Behavior
A condition characterized by involuntary muscle contractions and increased muscle tone that develops after damage to the central nervous system. The condition can manifest as muscle stiffness, spasms, and jerky movements. Spasticity can be either tonic (continuous muscle stiffness) or phasic (intermittent muscle contractions). The condition affects daily activities and body positioning.