pregabalin for the treatment and prevention of spinal cord injury neuropathic pain

Conditions: Neuropathic Pain; Spinal Cord Injuries

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.


Eligibility 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.

Keywords: pregabalin neuropathic pain at-level neuropathic pain non-evoked neuropathic pain evoked neuropathic pain sub-acute spinal cord injury