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 study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fznfqlaw ncxfhbwxl Mjaxz a Hdfofmn	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.10.2025

Trial locations

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.

Investigated diseases:

Muscle spasticity

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.

Trial ID:

2024-518824-56-00

Protocol code:

PoBSCI

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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Who Cannot Join the Study?