The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
2 mg titrated up to 8 mg maximum; taken once daily.
2 mg titrated up to 8 mg maximum; taken once daily.
Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)
Average pain scores are based on pain intensity (11-point Likert-type numerical scale, where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Time frame: Baseline and Week 15
Responder Rate: Subjects With at Least 30 Percent Reduction in Pain
A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Time frame: Baseline and Week 15
Responder Rate: Subjects With at Least 50 Percent Reduction in Pain
A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Time frame: Baseline and Week 15
Change From Baseline in Average Pain Scores by Week
Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.
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Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Boulder, Colorado, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Milford, Connecticut, United States
...and 37 more locations
Time frame: Week 1 through Week 16
Change From Baseline to Week 15/EOT in Average Sleep Interference Scores
The average of the last 7 available sleep scores prior to the visit, based on the 11-point Likert-type numerical rating scale for sleep interference (where 0=pain did not interfere with sleep, to 10=pain completely interfered with sleep \[unable to sleep\]), and they were reported by treatment group.
Time frame: Baseline and Week 15
Patient Global Impression of Change (PGIC) at Week 15/EOT
Changes were calculated using the modified BOCF method
Time frame: Week 15
Clinician Global Impression of Change (CGIC) at Week 15/EOT
Changes were calculated using the modified BOCF method
Time frame: Week 15
Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)
The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).
Time frame: Baseline and Week 15
Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)
The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).
Time frame: Baseline and Week 15
Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)
Allodynia is defined as a painful reaction to a non-painful stimulus.
Time frame: Week 15