NCT06066918

Brief Summary

Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4.6 years

First QC Date

September 28, 2023

Last Update Submit

June 18, 2025

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Outcome Measures

Primary Outcomes (2)

  • Central pain

    development of central pain by interview (yes /no )

    1 year

  • McGill Pain Questionnaire

    Range 0 -78. higher scores mean worse outcome.

    3 months

Study Arms (2)

Pregabalin

EXPERIMENTAL

Pregabalin 75 mg X2

Drug: Pregabalin 75mg

No treatment

NO INTERVENTION

no treatment

Interventions

Pregabalin 75mgDRUG

Pregabalin 75 mg twice a day

Also known as: Lyrica
Pregabalin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Up to 3 months following traumatic or non-traumatic SCL
  • Ability to give informed consent and cooperate

You may not qualify if:

  • Pregnancy
  • Neurological or other medical conditions that may interfere with sensation
  • Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
  • Being treated with Pregabalin
  • Blood creatinine levels \>1.2 or creatinine clearance \<60
  • Sensitivity to lactose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loewenstein Rehabilitation Hospital

Raanana, Israel

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Amiram Catz, Catz

    Loewenstein Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amiram Catz, Prof.

CONTACT

972-9-770-9934amiramc@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 4, 2023

Study Start

July 13, 2021

Primary Completion

February 5, 2026

Study Completion

February 5, 2026

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations

IL(1)