Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
Verified November 2011 by Hospital Nacional de Parapléjicos de Toledo
Information provided by (Responsible Party):
Julian Taylor Green, Hospital Nacional de Parapléjicos de Toledo
First received: November 17, 2011
Last updated: November 22, 2011
Last verified: November 2011
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.
Spinal Cord Injuries
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain
Primary Outcome Measures:
- Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: 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.
150mg BID p.o.
Active Comparator: 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.
Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.
Other Name: Lyrica
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479556
|Hospital Nacional de Parapléjicos de Toledo
|Toledo, Spain, 45071 |
Julian Taylor Green
No publications provided
||Julian Taylor Green, Dr. Julian Taylor Green, Hospital Nacional de Parapléjicos de Toledo
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 17, 2011
||November 22, 2011
||Spain: Spanish Agency of Medicines
Keywords provided by Hospital Nacional de Parapléjicos de Toledo:
At-level neuropathic pain
Non-evoked neuropathic pain
Evoked neuropathic pain
Sub-acute spinal cord injury
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action