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

Julian Taylor Green

Status and phase: Unknown; Phase 4

Conditions: Spinal Cord Injuries; Neuropathic Pain

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01479556

2011-000915-14 (EudraCT Number)

HNP-02-2011

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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82 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Pregabalin

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin