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

NCT01479556 | Unknown Phase 4

• 2 other identifiers: HNP-02-20112011-000915-14
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 (12)

• 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)

Study Arms (2)

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.

Drug: Placebo

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.

Drug: Pregabalin

Interventions

Pregabalin DRUG

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

Also known as: Lyrica

Pregabalin

Placebo DRUG

150mg BID p.o.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julian Taylor Green: lead

Study Sites (1)

Hospital Nacional de Parapléjicos de Toledo

Toledo, Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Julian Taylor Green

CONTACT

(34) 925 247 700; jscott@sescam.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Julian Taylor Green

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 24, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

ES (1)