Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain

• Status: Unknown status
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a phase IV clinical trial with the objective of evaluating whether pain relief associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more efficient during the early rather than late subacute phase of spinal cord injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julian Taylor Green
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Comprehension of clinical trial and signed informed consent before initiation.

• Male or female adults, age 18 to 70.

• Clinical history of neuropathic pain secondary to SCI

• Patients with an AIS of A, B, C or D according to the American Spinal Cord Injury Association (ASIA) Impairment Scale.

• Persistent neuropathic pain from 1 month up to 6 months after spinal cord injury.

• Non-evoked at-level pain with ≥ 2 intensity measured with the numerical rating scale (0-10).

• Non-evoked/evoked at-level pain corresponding to the area of sensory alteration, and within the three dermatomes below the neurological level of the spinal cord injury.

• Formal acceptance of disponibility for all programmed clinical trial visits and other protocol requisites.

• Females of child bearing age must demonstrate a negative pregnancy test (performed on screening and subsequent follow up visits) and use a reliable birth control method including abstinence of sexual activity throughout the duration of the study and for at last 28 days after termination of the clinical trial.

Exclusion Criteria:

• Previous or actual use of gabapentin.

• Creatinine clearance level <60 ml/min.

• Neuropathic pain unrelated to spinal cord injury.

• Lactose intolerance, Lapp lactase insufficiency or glucose malabsorption

• Platelet count < 100x103/µl.

• White blood cell count <2.5 x103/µl.

• Neutrophil count <1.5 x103/µl.

• Planned surgery during the clinical trial.

• Patients with peripheral neuropathic pain.

• Previous history of malignant melanoma.

• History of malignant tumors, except for in situ uterine cervix carcinoma, in situ basocellular or spinocellular cutaneous carcinomas, superficial bladder tumors (Ta and Tis) with a complete treatment response up to 10 years. Patients with history of lymphoma or breast cancer will be allowed to participate in the trial if a complete treatment response has been observed up to 20 years.

• Chronic or active infection requiring a systemic therapy, chronic kidney infections, chronic lung infections with bronchiectasias, Mycobacterium tuberculosis infection, active Hepatitis B or C. Diagnosis of latent TB confection should be performed according to the local guidelines.

• Severe heart diseases such as unstable angina, cardiopathy during the first 6 months after a myocardial infarction, grade III or IV of the New York Heart Association scale for congestive heart failure.

• Unknown kidney, liver, gastrointestinal, endocrine, lung, hematological, neurological or psychiatric comorbidities.

• Subjects administered with an experimental or non-commercial drug during the 4 weeks prior to the trial.

• Patients participating in other clinical studies.

• Patients that are not competent for completing required tasks (eg. alcohol or drug related problems or psychiatric disorders).

• Subjects unable to be examined with radiological MRI exploration due to contraindications.

• Pregnancy or breastfeeding.

• Any other patient condition that is deemed unsuitable for subject inclusion in the trial according to the research team.