Status:
UNKNOWN
Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
Lead Sponsor:
Julian Taylor Green
Conditions:
Neuropathic Pain
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01479556
Start Date
December 1 2011
End Date
October 1 2014
Last Update
November 24 2011
Active Locations (1)
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1
Hospital Nacional de Parapléjicos de Toledo
Toledo, Toledo, Spain, 45071