Pregabalin for Spinal cord injury (SCI) | Spasticity (spastic motor behaviour)

Inclusion criteria

• {"criterion_text":"- 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)\n- Age: 18-75 years old\n- MAS or MES 3 or higher during at least 3 days from 5\n- Ability and will to cooperate in the study\n- Written informed consent. If the patient is only able to consent orally a witness signs and confirms the patient’s consent.\n- Absence of serious comorbidities influencing spastic motor behaviour (serious infection, recent surgery…)\n- Hemodynamic and clinical stability\n- 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."}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Per-patient average of MES scores across the 30 days treatment.","definition_or_measurement_approach":"Measured as the per-patient average of MES scores recorded across the 30 days treatment period."}

Secondary endpoints

• {"endpoint_text":"- Per-patient average of MAS scores across the 30 days treatment","definition_or_measurement_approach":"Measured as the per-patient average of MAS scores recorded across the 30 days treatment period."}
• {"endpoint_text":"- Proportion of days when MES score is 3 or higher.","definition_or_measurement_approach":"Calculated as the proportion of days during the 30-day treatment period with MES score ≥ 3."}
• {"endpoint_text":"- Proportion of days when MAS score is 3 or higher.","definition_or_measurement_approach":"Calculated as the proportion of days during the 30-day treatment period with MAS score ≥ 3."}
• {"endpoint_text":"- ADL evaluated by SCI-SET (relevant questions).","definition_or_measurement_approach":"Activities of daily living assessed using relevant questions from the SCI-SET instrument."}
• {"endpoint_text":"- Functioning assessed by the Spinal Cord Independence Measure (SCIM-III).","definition_or_measurement_approach":"Functioning measured using the Spinal Cord Independence Measure (SCIM-III) scale."}
• {"endpoint_text":"- Quality of life evaluated by WHOQOL-BREF questionnaire.","definition_or_measurement_approach":"Quality of life assessed using the WHOQOL-BREF questionnaire."}

Czechia

Earliest CTIS Part Ii Submission Date

15-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

35

Number Of Sites

1

Number Of Participants

28

Primary sponsor

Full Name

Fakultni Nemocnice V Motole

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Czechia