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NCT Number: NCT06066918

Prophylactic Pregabalin Treatment Following Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loewenstein Rehabilitation Hospital

Raanana, Israel

Location status: Recruiting

Location contact

Sara Lipkin

CONTACT

About this study

Patients arriving to rehabilitation up to 3 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pregabalin 75mg

Drug

Pregabalin 75 mg twice a day

Other names: Lyrica

Primary outcomes

  1. Central pain

    Time frame: 1 year

    development of central pain by interview (yes /no )

  2. McGill Pain Questionnaire

    Time frame: 3 months

    Range 0 -78. higher scores mean worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Amiram Catz, Prof.

CONTACT

[email protected]

972-9-770-9934

Sponsors and collaborators

Lead sponsor

Loewenstein Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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