Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
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|ClinicalTrials.gov Identifier: NCT00592904|
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : February 8, 2013
Last Update Posted : January 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuralgia||Drug: E2007||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||July 2011|
Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).
Other Name: Perampanel
- Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. [ Time Frame: Baseline and Week 48 ]Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
- Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48. [ Time Frame: Baseline and Week 48 ]SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
- Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ]Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).
- Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT) [ Time Frame: Baseline and Week 48 ]The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].
- Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT [ Time Frame: Baseline and Week 48 ]Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.
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): NCT00592904
|United States, Illinois|
|Chicago, Illinois, United States, 60610|
|Study Director:||Antonio Laurenza, M. D.||Eisai Inc.|