Overview

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.