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Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Pregabalin 75mg
Sponsored by
Loewenstein Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loewenstein Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pregabalin

No treatment

Arm Description

Pregabalin 75 mg X2

no treatment

Outcomes

Primary Outcome Measures

Central pain
development of central pain

Secondary Outcome Measures

Full Information

First Posted
September 28, 2023
Last Updated
October 4, 2023
Sponsor
Loewenstein Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06066918
Brief Title
Prophylactic Pregabalin Treatment Following Spinal Cord Injury
Official Title
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
February 5, 2025 (Anticipated)
Study Completion Date
February 5, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Spinal Cord Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Pregabalin 75 mg X2
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg
Other Intervention Name(s)
Lyrica
Intervention Description
Pregabalin 75 mg twice a day
Primary Outcome Measure Information:
Title
Central pain
Description
development of central pain
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amiram Catz, Dr
Phone
972-9-770-9934
Email
amiramc@clalit.org.il
Facility Information:
Facility Name
Loewenstein Rehabilitation Hospital
City
Ra'anana
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Lipkin

12. IPD Sharing Statement

Learn more about this trial

Prophylactic Pregabalin Treatment Following Spinal Cord Injury

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