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Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study
EU CTIS ID: 2024-518824-56-00
What this study is testing
To prove better efficacy of Pregabalin in SCI patients with predominant phasic (dynamic) component of spastic motor behaviour compared to Baclofen.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sub-acute (2-40 days after the injury) cervical or thoracic (NLI C4-T10) spinal cord lesion (SCI), complete or incomplete (AIS A-C), with severe spastic motor behaviour (static or dynamic)
- Age: 18-75 years old
- MAS or MES 3 or higher during at least 3 days from 5
- Ability and will to cooperate in the study
- Written informed consent. If the patient is only able to consent orally a witness signs and confirms the patient’s consent.
- Absence of serious comorbidities influencing spastic motor behaviour (serious infection, recent surgery…)
You likely can't join if
- History of hypersensitivity to IMP (Pregabalin and/or Baclofen)
- Neuropathic pain stronger than VAS 5
- Previous medication for spastic motor behaviour or neuropathic pain or epilepsy (pregabalin, neurontin, baclofen, rivotril, sirdalud...)
- Pregnancy or breastfeeding
- Renal dysfunction (creatinine level over 120 umol/l, urea level over 10 mmol/l)
- Liver dysfunction (liver enzymes over 2,5 ukat/l)
See the full eligibility criteria
- Sub-acute (2-40 days after the injury) cervical or thoracic (NLI C4-T10) spinal cord lesion (SCI), complete or incomplete (AIS A-C), with severe spastic motor behaviour (static or dynamic)
- Age: 18-75 years old
- MAS or MES 3 or higher during at least 3 days from 5
- Ability and will to cooperate in the study
- Written informed consent. If the patient is only able to consent orally a witness signs and confirms the patient’s consent.
- Absence of serious comorbidities influencing spastic motor behaviour (serious infection, recent surgery…)
- Hemodynamic and clinical stability
- Males and Females of childbearing potential willing to use highly effective method of contraception (hormonal contraception, intrauterine device or sexual abstinence) during the treatment period and for at least one month after the last dose of study drug.
- History of hypersensitivity to IMP (Pregabalin and/or Baclofen)
- Neuropathic pain stronger than VAS 5
- Previous medication for spastic motor behaviour or neuropathic pain or epilepsy (pregabalin, neurontin, baclofen, rivotril, sirdalud...)
- Pregnancy or breastfeeding
- Renal dysfunction (creatinine level over 120 umol/l, urea level over 10 mmol/l)
- Liver dysfunction (liver enzymes over 2,5 ukat/l)
- BMI ˃ 35kg/m2
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.