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Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Sponsor
Loewenstein Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06066918
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
54.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients arriving to rehabilitation up to 2 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin 75mg
 N/A

Detailed Description

Patients arriving to rehabilitation up to 2 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Actual Study Start Date :
Jul 13, 2021
Anticipated Primary Completion Date :
Feb 5, 2025
Anticipated Study Completion Date :
Feb 5, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregabalin

Pregabalin 75 mg X2

Drug: Pregabalin 75mg
Pregabalin 75 mg twice a day
Other Names:
  • Lyrica

    		•
    No Intervention: No treatment

    no treatment

    Outcome Measures

    Primary Outcome Measures

    1. Central pain [1 year]

      development of central pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • spinal cord injury / lesion below C3.

    • up to 2 months from onset

    Exclusion Criteria:

    • Pregnancy

    • other medical conditions that might influence sensation

    • pain (chronic or acute)

    • Creatinine>1.2 mg/DL

    • Lactose sensitivity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loewenstein Rehabilitation Hospital Ra'anana Israel

    Sponsors and Collaborators

    • Loewenstein Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    amiram-catz, Principal Investigator, Loewenstein Hospital
    ClinicalTrials.gov Identifier:
    NCT06066918
    Other Study ID Numbers:
    • 0012-19-LOE
    First Posted:
    Oct 4, 2023
    Last Update Posted:
    Oct 6, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Cord Injuries
    Spinal Cord Diseases
    Wounds and Injuries
    Pregabalin

    Study Results

    No Results Posted as of Oct 6, 2023