Pregabalin for the Treatment and Prevention of Spinal Cord Injury Neuropathic Pain
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|ClinicalTrials.gov Identifier: NCT01479556|
Recruitment Status : Unknown
Verified November 2011 by Julian Taylor Green, Hospital Nacional de Parapléjicos de Toledo.
Recruitment status was: Not yet recruiting
First Posted : November 24, 2011
Last Update Posted : November 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain Spinal Cord Injuries||Drug: Pregabalin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||October 2014|
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
- Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479556
|Contact: Julian Taylor Green||(34) 925 247 700 ext firstname.lastname@example.org|
|Hospital Nacional de Parapléjicos de Toledo||Not yet recruiting|
|Toledo, Spain, 45071|