Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy
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|ClinicalTrials.gov Identifier: NCT02607254|
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Small Fiber Neuropathy||Drug: Pregabalin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
Experimental: Pregabalin Treatment phase
All patients will be initially treated with pregabalin in a single blind fashion
Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.
Other Name: Lyrica
Experimental: Withdrawal phase
After finishing the treatment phase, some patients will be randomized to the placebo or continue on pregabalin for the 4 weeks of withdrawal phase.
Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
- Visual Analogue Score for Pain Intensity. [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.
- Brief Pain Inventory (BPI sf); [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.
- Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS); [ Time Frame: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.
- Patient Global Impression of Change (PGIC); [ Time Frame: At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase ]patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.
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): NCT02607254
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Mohammad Khoshnoodi, MD||Johns Hopkins University|