Clinical trial NCT01479556: Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
Official title: Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neuropathic Pain
Spinal Cord Injuries
Keywords: Pregabalin
Neuropathic pain
At-level neuropathic pain
Non-evoked neuropathic pain
Evoked neuropathic pain
Sub-acute spinal cord injury
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
Secondary outcomes:
measure: Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)
measure: Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)
measure: Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)
measure: Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)
measure: Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
measure: Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire
measure: Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI
measure: Serum TNF-R1 level
measure: Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial
measure: Number of Paracetamol tablets used as rescue medication during the week
measure: Prevalence and type of adverse events in patients treated with pregabalin
measure: 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.
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos de Toledo
Study officials:
References: