Clinical trial

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

Name

0012-19-LOE

Description

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.

Trial arms

Trial start

2021-07-13

Estimated PCD

2025-02-05

Trial end

2026-02-05

Status

Recruiting

Treatment

Pregabalin 75mg

Pregabalin 75 mg twice a day

Arms:

Pregabalin

Other names:

Lyrica

Size

Primary endpoint

Central pain

1 year

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-10-06

1 organization

1 product

2 indications

Organization

Product

Indication

Indication