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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01479556
Other study ID # HNP-02-2011
Secondary ID 2011-000915-14
Status Not yet recruiting
Phase Phase 4
First received November 17, 2011
Last updated November 22, 2011
Start date December 2011
Est. completion date October 2014

Study information

Verified date November 2011
Source Hospital Nacional de Parapléjicos de Toledo
Contact Julian Taylor Green
Phone (34) 925 247 700
Email jscott@sescam.org
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 82
Est. completion date October 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Hospital Nacional de Parapléjicos de Toledo Toledo

Sponsors (1)

Lead Sponsor Collaborator
Julian Taylor Green

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
Secondary Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)
Secondary Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)
Secondary Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)
Secondary Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)
Secondary Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Secondary Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire
Secondary Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI
Secondary Serum TNF-R1 level
Secondary Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial
Secondary Number of Paracetamol tablets used as rescue medication during the week
Secondary Prevalence and type of adverse events in patients treated with pregabalin
Secondary 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.
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