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Taking peoplePhase 3

Pregabalin compared with baclofen for muscle spasms after spinal cord injury

Compares pregabalin with baclofen for spastic muscle behaviour in adults with spinal cord injury.

Key facts

Who runs it
Fakultni Nemocnice V Motole
Where
Czechia1 site in 1 countryChoose a country to see its sites
Registry title
Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study
Status
Recruiting
Phase
Phase 3
People taking part
28 people, planned
Started
26 May 2026
Expected to end
1 Oct 2027
Type of study
Interventional
Record updated
20 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a recent spinal cord injury in the neck or upper back who have severe spasticity (stiff or jerking muscles). It compares Pregabalin with Baclofen.

Age
18-75 years old
Sex
Men and women can join.
Disease stage
Sub-acute spinal cord injury, 2-40 days after the injury, at level C4-T10. The injury can be complete or incomplete (AIS A-C). Spasticity must be severe: MAS or MES score 3 or higher on at least 3 of 5 days. People must be stable in their blood circulation and overall condition.
Earlier treatment
People cannot have had earlier medicine for spasticity, nerve pain or epilepsy (for example pregabalin, neurontin, baclofen, rivotril, sirdalud).

Main reasons for not taking part

  • Allergy to Pregabalin or Baclofen
  • Nerve pain stronger than VAS 5
  • Pregnancy or breastfeeding
  • Kidney problems (creatinine over 120 umol/l (1.36 mg/dL), urea over 10 mmol/l) or liver problems (liver enzymes over 2,5 ukat/l)
  • BMI over 35kg/m2, or serious other illness affecting spasticity, such as serious infection or recent surgery

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous medication for spastic motor behaviour or neuropathic pain or epilepsy (pregabalin, neurontin, baclofen, rivotril, sirdalud...)
  • History of hypersensitivity to IMP (Pregabalin and/or Baclofen)
  • Renal dysfunction (creatinine level over 120 umol/l, urea level over 10 mmol/l)
  • Neuropathic pain stronger than VAS 5
  • Pregnancy or breastfeeding
  • Liver dysfunction (liver enzymes over 2,5 ukat/l)
  • BMI ˃ 35kg/m2

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To prove better efficacy of Pregabalin in SCI patients with predominant phasic (dynamic) component of spastic motor behaviour compared to Baclofen.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study
Plain-language title
Pregabalin compared with baclofen for muscle spasms after spinal cord injuryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
20 October 2025