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NCT06066918 Clinical Trial

Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:
The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06066918
Other study ID # 0012-19-LOE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 13, 2021
Est. completion date February 5, 2026

Study information
Verified date October 2023
Source Loewenstein Hospital
Contact Amiram Catz, Dr
Phone 972-9-770-9934
Email amiramc@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date February 5, 2026
Est. primary completion date February 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin 75mg
Pregabalin 75 mg twice a day

Locations
Country Name City State
Israel Loewenstein Rehabilitation Hospital Ra'anana

Sponsors (1)
Lead Sponsor Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central pain development of central pain 1 year
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