Prophylactic Pregabalin Treatment Following Spinal Cord Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2026-02-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Cord Injuries Spinal Cord Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pregabalin

Pregabalin 75 mg X2

Group Type EXPERIMENTAL

Pregabalin 75mg

Intervention Type DRUG

Pregabalin 75 mg twice a day

No treatment

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pregabalin 75mg

Pregabalin 75 mg twice a day

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No