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Pregabalin or Baclofen in Spastic Motor Behavior Treatment After SCI (PoBSCI), Prospective, Double-Blind, Randomised Drug Study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518824-56-00
Acronym
PoBSCI
Enrollment
28
Registered
2025-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete to incomplete (AIS A-C) sub-acute cervical or thoracic (NLI C4-T10) spinal cord injury (SCI) with severe spastic motor behaviour

Brief summary

Per-patient average of MES scores across the 30 days treatment.

Detailed description

Per-patient average of MAS scores across the 30 days treatment, Proportion of days when MES score is 3 or higher., Proportion of days when MAS score is 3 or higher., ADL evaluated by SCI-SET (relevant questions)., Functioning assessed by the Spinal Cord Independence Measure (SCIM-III)., Quality of life evaluated by WHOQOL-BREF questionnaire.

Interventions

DRUGPregabalin Sandoz 50 mg hard capsules
DRUGBACLOFEN POLPHARMA 10 mg tablety

Sponsors

Fakultni Nemocnice V Motole
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Per-patient average of MES scores across the 30 days treatment.

Secondary

MeasureTime frame
Per-patient average of MAS scores across the 30 days treatment, Proportion of days when MES score is 3 or higher., Proportion of days when MAS score is 3 or higher., ADL evaluated by SCI-SET (relevant questions)., Functioning assessed by the Spinal Cord Independence Measure (SCIM-III)., Quality of life evaluated by WHOQOL-BREF questionnaire.

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026