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

Condition(s) targeted: Neuropathic Pain; Spinal Cord Injuries

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Julian Taylor Green

Overall contact:
Julian Taylor Green, Phone: (34) 925 247 700, Ext: 109, Email: jscott@sescam.org

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.

Official title: Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity

Secondary outcome:

Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)

Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)

Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)

Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)

Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)

Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire

Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI

Serum TNF-R1 level

Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial

Number of Paracetamol tablets used as rescue medication during the week

Prevalence and type of adverse events in patients treated with pregabalin

Unblinding testing: patient and investigator will be asked for the treatment they think to have received. Reasons for their judgement (efficacy and safety) will also be asked.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Julian Taylor Green, Phone: (34) 925 247 700, Ext: 109, Email: jscott@sescam.org

Hospital Nacional de Parapléjicos de Toledo, Toledo 45071, Spain; Not yet recruiting

Starting date: December 2011
Last updated: November 22, 2011