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Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

NCT06564714 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-08-21

No results posted yet for this study

Summary

The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunctional recovery after tSCI.

The main questions it aims to answer are :

1. Assess the safety of early baclofen treatment during acute care after SCI.
2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.

The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.

Conditions

  • Traumatic Spinal Cord Injury

Interventions

DRUG

Early baclofen Intervention

Baclofen is initiated as soon as any sign of acute spasticity. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic.

DRUG

Usual routine care

Baclofen is initiated only when acute spasticity is deemed problematic. 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response.

Sponsors & Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Principal Investigators

  • Andréane Richard-Denis, M.D., MSC · CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564714 on ClinicalTrials.gov