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

NCT ID: NCT01479556

Last Updated: 2011-11-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

150mg BID p.o.

Pregabalin

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.

Interventions

Pregabalin

Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.

Intervention Type: DRUG

Placebo

150mg BID p.o.

Intervention Type: DRUG

Other Intervention Names

Lyrica

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Julian Taylor Green

OTHER

Sponsor Role: lead

Responsible Party

Julian Taylor Green

Dr. Julian Taylor Green

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Nacional de Parapléjicos de Toledo

Toledo, Toledo, Spain

Countries

Spain

Central Contacts

Julian Taylor Green

Role: CONTACT

Phone: (34) 925 247 700

Email: jscott@sescam.org

Other Identifiers

2011-000915-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HNP-02-2011

Identifier Type: -

Identifier Source: org_study_id