--- title: Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain nct_id: NCT01479556 overall_status: UNKNOWN phase: PHASE4 sponsor: Julian Taylor Green study_type: INTERVENTIONAL primary_condition: Neuropathic Pain countries: Spain canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01479556.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01479556" ct_last_update_post_date: 2011-11-24 last_seen_at: "2026-05-12T07:08:42.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01479556](https://clinicaltrials.gov/study/NCT01479556) ## Key Facts - **Status:** UNKNOWN - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 82 - **Lead Sponsor:** Julian Taylor Green - **Conditions:** Neuropathic Pain, Spinal Cord Injuries - **Start Date:** 2011-12 - **Completion Date:** 2014-10 - **CT.gov Last Update:** 2011-11-24 ## 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 - **Minimum age:** 18 Years - **Maximum age:** 70 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Placebo** (PLACEBO_COMPARATOR) — Study subjects wil be randomized to the Placebo arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. - **Pregabalin** (ACTIVE_COMPARATOR) — Study subjects wil be randomized to the Pregabalin arm following a stratification procedure based on AIS scale (A-E), neurological level of injury (cervical or thoracic), and presence of at-level neuropathic pain before or after 3 months from the time of spinal cord injury. ## Interventions - **Pregabalin** (DRUG) — Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o. - **Placebo** (DRUG) — 150mg BID p.o. ## Primary Outcomes - **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 - **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.** ## Locations (1) - Hospital Nacional de Parapléjicos de Toledo, Toledo, Toledo, Spain ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hospital nacional de parapléjicos de toledo|toledo|toledo|spain` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01479556.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01479556* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*