Diabetic Neuropathy
Conditions
Keywords
Diabetic neuropathy
Brief summary
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
Interventions
DRUGPlacebo
Placebo tablets, once daily, for 15 weeks (taken orally).
DRUGE2007 (2 mg)
Perampanel, 2 mg once daily, for 15 weeks (taken orally).
DRUGE2007 (4 mg)
Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).
DRUGE2007 (6 mg)
Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).
DRUGE2007 (8 mg)
Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).
Sponsors
Eisai Limited
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included, patients must meet all of the following: 1. Provide written informed consent, prior to entering the study or undergoing any study procedures 2. Male and female patients ≥18 years of age will be eligible for enrollment. Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \[IUD\]) for at least 1 month before Screening (Visit 1) and for 1 month after the end of the study (Visit 8). They must also have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening (Visit 1). Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) starting with the Baseline Phase and continuing throughout the study period. 3. Have Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration 4. Have pain that has been stable over the past 6 months and, in the opinion of the investigator, not in an identifiably improving or worsening trend 5. Have hemoglobin A1c ≤ 11% 6. Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Screening (Visit 1) and Baseline (Visit 2 prior to randomization) 7. Have completed the patient diary for at least 6 of the 7 days prior to Baseline (Visit 2) 8. Have average daily pain score of ≥ 4, on 11-point Likert-type numeric rating scale during the 7 days prior to Baseline (to be obtained from the patient diary) 9. Be reliable, willing, and able to cooperate with all study procedures including the following: 1. accurately fill out the diary on a daily basis 2. return for study visits on the required dates 3. accurately and reliably report symptoms (including treatment-emergent signs and symptoms) 4. take study drug as required by protocol 10. Be on stable antidiabetic treatment (insulin, oral agents, or lifestyle) that is not anticipated to change during the course of the study, except if medically required 11. Be on stable analgesic treatment (same medication and dose) or stable nonpharmacological pain treatment for at least 4 weeks prior to Screening (Visit 1) and remain on this stable treatment throughout the study (unless otherwise directed by a physician). Nonpharmacologic pain treatment includes the following: relaxation/hypnosis, physical or occupational therapy, counseling, etc. Episodic or periodic treatments such as monthly injections for treatment of pain (e.g., local anesthetics) will not be permitted.
Exclusion criteria
Patients with any one of the following will be excluded. 1. Patients with any condition that could interfere with the conduct of the study or confound efficacy evaluations including the following: 1. Pain or neuropathy from another cause (including central pain, radiculopathy, painful arthritis, etc.) 2. Skin or soft-tissue lesions in the area affected by neuropathy that are painful or could alter sensation 3. Amputation, other than toes 2. Patients motivated by secondary gain, or where there is a negative-incentive to achieving pain and functional pain relief (eg, litigation). This will be determined by the patient's medical history. 3. Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine (other than diabetes), or immunologic, including patients with any of the following broad disease categories: 1. Systemic infections (e.g., human immunodeficiency virus \[HIV\], hepatitis, tuberculosis \[TB\], syphilis) 2. History of past (within the past 12 months) or present drug or alcohol abuse as per the Diagnostic and Statistical Manual - 4th Edition (DSM IV) criteria 3. History of acute coronary syndrome within the past 12 months 4. Active cancer within the previous 5 years 5. Systemic chemotherapy or immunotherapy within the past 5 years 6. History of major depression, bipolar disease, psychosis or suicidal ideation or attempts within the past 5 years 4. Patients with any of the following laboratory abnormalities at Screening (Visit 1) or Baseline (Visit 2): 1. Clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc (defined as QTc ≥ 450 msec) 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN) 3. White blood cell (WBC) count ≤ 2500/μL, absolute neutrophil count ≤ 1000/μL, platelet count \< 100,000 4. Positive urine drug screen for drugs of abuse, except those prescribed by a properly licensed practitioner (e.g., opioids such as codeine for neuropathic pain) 5. Other clinically significant laboratory values 5. Exposure to an investigational drug (including E2007) within the 30 days prior to Screening (Visit 1) or any prior exposure to E2007.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF). |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Baseline to Week 15/EOT | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. |
| Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Baseline to Week 15/EOT | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF. |
| Mean Change in Average Pain Scores From Baseline at Each Study Week | Baseline, Week 1 to Week 17 | Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Baseline and Week 15/EOT | Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status. |
| Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Baseline and Week 15/EOT | HADS anxiety subscale score=sum of scores for 7 anxiety items, 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, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, 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, 0 to 21. |
| Presence or Absence of Allodynia at Week 15/EOT | Week 15/EOT | Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed. |
| Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Baseline to Week 15 | If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication. |
| Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Baseline and Week 15 | Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure. |
| Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | Baseline to Week 15/EOT | Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep \[unable to sleep\]). Based on modified BOCF. |
| Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | Baseline and Week 15/EOT | SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity. |
| Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Week 15/EOT | At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 71 |
| Perampanel 2mg (Perampanel 2mg once daily for 15 weeks) | 71 |
| Perampanel 4mg (Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks) | 68 |
| Perampanel 6mg (Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks) | 67 |
| Perampanel 8mg (Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks) | 68 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 7 | 9 | 14 | 22 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 | 1 | 1 |
| Overall Study | Other | 5 | 0 | 0 | 4 | 4 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 1 | 0 | 6 |
Baseline characteristics
| Characteristic | Placebo | Perampanel 2mg | Perampanel 4mg | Perampanel 6mg | Perampanel 8mg | Total |
|---|---|---|---|---|---|---|
| Age, Customized <65 years | 50 Participants | 50 Participants | 40 Participants | 34 Participants | 41 Participants | 215 Participants |
| Age, Customized >=65 years | 21 Participants | 21 Participants | 28 Participants | 33 Participants | 27 Participants | 130 Participants |
| Race/Ethnicity, Customized Asian | 4 participants | 1 participants | 2 participants | 0 participants | 0 participants | 7 participants |
| Race/Ethnicity, Customized Black | 8 participants | 11 participants | 4 participants | 4 participants | 6 participants | 33 participants |
| Race/Ethnicity, Customized Other | 3 participants | 3 participants | 6 participants | 3 participants | 2 participants | 17 participants |
| Race/Ethnicity, Customized White | 56 participants | 56 participants | 56 participants | 60 participants | 60 participants | 288 participants |
| Sex: Female, Male Female | 37 Participants | 27 Participants | 28 Participants | 34 Participants | 25 Participants | 151 Participants |
| Sex: Female, Male Male | 34 Participants | 44 Participants | 40 Participants | 33 Participants | 43 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 71 | 30 / 71 | 33 / 68 | 40 / 67 | 38 / 68 |
| serious Total, serious adverse events | 2 / 71 | 2 / 71 | 2 / 68 | 8 / 67 | 8 / 68 |
Outcome results
Primary
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).
Time frame: Baseline to Week 15/EOT
Population: Intent-to-Treat (ITT) Population - Randomized subjects who took at least 1 dose of study drug and had at least 1 efficacy assessment at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | -2.22 Scores on a Scale | Standard Deviation 2.19 |
| Perampanel 2mg | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | -1.73 Scores on a Scale | Standard Deviation 2.34 |
| Perampanel 4mg | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | -1.30 Scores on a Scale | Standard Deviation 2.18 |
| Perampanel 6mg | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | -1.85 Scores on a Scale | Standard Deviation 2.01 |
| Perampanel 8mg | Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT) | -1.18 Scores on a Scale | Standard Deviation 2 |
Primary
Mean Change in Average Pain Scores From Baseline at Each Study Week
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.
Time frame: Baseline, Week 1 to Week 17
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 3 | -1.19 Scores on a Scale | Standard Deviation 1.85 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 16 | -2.40 Scores on a Scale | Standard Deviation 2.38 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 7 | -1.99 Scores on a Scale | Standard Deviation 1.96 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 10 | -2.30 Scores on a Scale | Standard Deviation 1.96 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 17 | NA Scores on a Scale | — |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 4 | -1.46 Scores on a Scale | Standard Deviation 1.73 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 1 | -0.58 Scores on a Scale | Standard Deviation 1.46 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 5 | -1.49 Scores on a Scale | Standard Deviation 1.71 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 13 | -2.36 Scores on a Scale | Standard Deviation 2 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 15 | -2.39 Scores on a Scale | Standard Deviation 2.23 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 9 | -2.19 Scores on a Scale | Standard Deviation 2.1 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 12 | -2.46 Scores on a Scale | Standard Deviation 1.99 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 11 | -2.39 Scores on a Scale | Standard Deviation 2.03 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 14 | -2.30 Scores on a Scale | Standard Deviation 2.17 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 2 | -0.87 Scores on a Scale | Standard Deviation 1.65 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 8 | -1.91 Scores on a Scale | Standard Deviation 2.01 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 6 | -1.73 Scores on a Scale | Standard Deviation 1.81 |
| Placebo | Mean Change in Average Pain Scores From Baseline at Each Study Week | Last On-Treatment Value | -2.24 Scores on a Scale | Standard Deviation 2.18 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 11 | -1.98 Scores on a Scale | Standard Deviation 2.2 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 12 | -1.81 Scores on a Scale | Standard Deviation 2.31 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 13 | -1.80 Scores on a Scale | Standard Deviation 2.16 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Last On-Treatment Value | -1.79 Scores on a Scale | Standard Deviation 2.32 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 14 | -1.84 Scores on a Scale | Standard Deviation 2.31 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 3 | -1.33 Scores on a Scale | Standard Deviation 1.64 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 6 | -1.70 Scores on a Scale | Standard Deviation 2.17 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 4 | -1.33 Scores on a Scale | Standard Deviation 2.01 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 17 | -5.50 Scores on a Scale | Standard Deviation 3.33 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 5 | -1.55 Scores on a Scale | Standard Deviation 2.21 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 15 | -1.99 Scores on a Scale | Standard Deviation 2.39 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 7 | -1.84 Scores on a Scale | Standard Deviation 2.1 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 2 | -1.09 Scores on a Scale | Standard Deviation 1.53 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 8 | -1.86 Scores on a Scale | Standard Deviation 2.05 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 9 | -1.86 Scores on a Scale | Standard Deviation 2.14 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 16 | -2.49 Scores on a Scale | Standard Deviation 2.2 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 10 | -1.88 Scores on a Scale | Standard Deviation 2.19 |
| Perampanel 2mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 1 | -0.71 Scores on a Scale | Standard Deviation 1.33 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 15 | -1.58 Scores on a Scale | Standard Deviation 2.16 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 1 | -0.58 Scores on a Scale | Standard Deviation 1.39 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 2 | -0.80 Scores on a Scale | Standard Deviation 1.55 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 10 | -1.84 Scores on a Scale | Standard Deviation 2.12 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 8 | -1.72 Scores on a Scale | Standard Deviation 2.2 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 16 | -1.50 Scores on a Scale | Standard Deviation 2.12 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 13 | -1.62 Scores on a Scale | Standard Deviation 2.29 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 11 | -1.85 Scores on a Scale | Standard Deviation 2.14 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 6 | -1.31 Scores on a Scale | Standard Deviation 2.12 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 9 | -1.76 Scores on a Scale | Standard Deviation 2.19 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 14 | -1.56 Scores on a Scale | Standard Deviation 2.27 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 5 | -1.12 Scores on a Scale | Standard Deviation 2.08 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 4 | -1.10 Scores on a Scale | Standard Deviation 1.93 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 12 | -1.76 Scores on a Scale | Standard Deviation 2.16 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 17 | NA Scores on a Scale | — |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 3 | -0.91 Scores on a Scale | Standard Deviation 1.67 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Last On-Treatment Value | -1.48 Scores on a Scale | Standard Deviation 2.23 |
| Perampanel 4mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 7 | -1.50 Scores on a Scale | Standard Deviation 2.04 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 16 | -1.87 Scores on a Scale | Standard Deviation 2.12 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 8 | -2.19 Scores on a Scale | Standard Deviation 2.23 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 1 | -0.79 Scores on a Scale | Standard Deviation 1.44 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 2 | -1.19 Scores on a Scale | Standard Deviation 1.71 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 3 | -1.53 Scores on a Scale | Standard Deviation 1.92 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 4 | -1.75 Scores on a Scale | Standard Deviation 1.99 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 5 | -1.93 Scores on a Scale | Standard Deviation 1.96 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 6 | -2.03 Scores on a Scale | Standard Deviation 2.14 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 7 | -2.31 Scores on a Scale | Standard Deviation 2.32 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 9 | -2.28 Scores on a Scale | Standard Deviation 2.12 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 10 | -2.04 Scores on a Scale | Standard Deviation 1.98 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 11 | -2.10 Scores on a Scale | Standard Deviation 2.09 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 12 | -2.13 Scores on a Scale | Standard Deviation 2.11 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 13 | -2.23 Scores on a Scale | Standard Deviation 1.99 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 14 | -2.25 Scores on a Scale | Standard Deviation 2 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 15 | -2.36 Scores on a Scale | Standard Deviation 1.91 |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 17 | NA Scores on a Scale | — |
| Perampanel 6mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Last On-Treatment Value | -2.41 Scores on a Scale | Standard Deviation 2.15 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 11 | -1.95 Scores on a Scale | Standard Deviation 2.06 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 5 | -1.56 Scores on a Scale | Standard Deviation 1.94 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 15 | -1.93 Scores on a Scale | Standard Deviation 2.23 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 10 | -1.92 Scores on a Scale | Standard Deviation 2.08 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 9 | -2.01 Scores on a Scale | Standard Deviation 2.31 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 8 | -1.71 Scores on a Scale | Standard Deviation 2.18 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 7 | -1.80 Scores on a Scale | Standard Deviation 1.98 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 16 | -1.88 Scores on a Scale | Standard Deviation 2.01 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 6 | -1.58 Scores on a Scale | Standard Deviation 2.11 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 4 | -1.38 Scores on a Scale | Standard Deviation 1.97 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 3 | -1.22 Scores on a Scale | Standard Deviation 1.75 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Last On-Treatment Value | -1.69 Scores on a Scale | Standard Deviation 2.24 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 17 | 0.71 Scores on a Scale | — |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 2 | -1.05 Scores on a Scale | Standard Deviation 1.52 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 13 | -2.01 Scores on a Scale | Standard Deviation 2.17 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 12 | -1.91 Scores on a Scale | Standard Deviation 2.16 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 1 | -0.72 Scores on a Scale | Standard Deviation 1.33 |
| Perampanel 8mg | Mean Change in Average Pain Scores From Baseline at Each Study Week | Week 14 | -1.89 Scores on a Scale | Standard Deviation 2.19 |
Primary
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Time frame: Baseline to Week 15/EOT
Population: ITT Population. A responder was defined as a subject who had at least a 30% reduction in average pain scores from Baseline to Week 15/EOT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Responders (Yes) | 56.3 Percentage of Participants |
| Placebo | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Non-responders (No) | 43.7 Percentage of Participants |
| Perampanel 2mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Responders (Yes) | 36.6 Percentage of Participants |
| Perampanel 2mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Non-responders (No) | 63.4 Percentage of Participants |
| Perampanel 4mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Responders (Yes) | 32.4 Percentage of Participants |
| Perampanel 4mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Non-responders (No) | 67.6 Percentage of Participants |
| Perampanel 6mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Non-responders (No) | 60.6 Percentage of Participants |
| Perampanel 6mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Responders (Yes) | 39.4 Percentage of Participants |
| Perampanel 8mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Responders (Yes) | 31.9 Percentage of Participants |
| Perampanel 8mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score | Non-responders (No) | 68.1 Percentage of Participants |
Primary
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Time frame: Baseline to Week 15/EOT
Population: ITT Population. A responder was defined as a subject who had at least a 50% reduction in average pain scores from Baseline to Week 15/EOT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Responders (Yes) | 38 Percentage of Participants |
| Placebo | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Non-responders (No) | 62 Percentage of Participants |
| Perampanel 2mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Responders (Yes) | 23.9 Percentage of Participants |
| Perampanel 2mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Non-responders (No) | 76.1 Percentage of Participants |
| Perampanel 4mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Responders (Yes) | 22.1 Percentage of Participants |
| Perampanel 4mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Non-responders (No) | 77.9 Percentage of Participants |
| Perampanel 6mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Non-responders (No) | 69.7 Percentage of Participants |
| Perampanel 6mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Responders (Yes) | 30.3 Percentage of Participants |
| Perampanel 8mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Responders (Yes) | 18.8 Percentage of Participants |
| Perampanel 8mg | Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score | Non-responders (No) | 81.2 Percentage of Participants |
Secondary
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT
At the EOT (Visit 7) or Early Withdrawal Visit (as appropriate), the subject assessed his/her status compared to how they felt before entering the study. This assessment included an evaluation of pain frequency and intensity, the occurrence of AEs, and overall functional status using a 7-point scale where 1=very much improved and 7=very much worse. Using Modified BOCF.
Time frame: Week 15/EOT
Population: Subset of ITT population used, including subjects that completed PGIC at Week 15 visit, and using BOCF (baseline observation carried forward) subjects that terminated prior to Week 15 received a 'No Change' if due to AE or Lack of Therapeutic Efficacy, subjects who discontinued due to other reasons used PGIC scores from Early Termination visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Very much improved | 9 Participants |
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much worse | 1 Participants |
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much improved | 17 Participants |
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally improved | 18 Participants |
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally worse | 3 Participants |
| Placebo | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | No change | 18 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally worse | 3 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally improved | 18 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much improved | 13 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Very much improved | 3 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much worse | 1 Participants |
| Perampanel 2mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | No change | 24 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Very much improved | 4 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much improved | 15 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally improved | 20 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally worse | 3 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | No change | 24 Participants |
| Perampanel 4mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much worse | 0 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | No change | 28 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much worse | 1 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much improved | 14 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally improved | 13 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Very much improved | 3 Participants |
| Perampanel 6mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally worse | 3 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much worse | 1 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Much improved | 8 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally improved | 10 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | No change | 31 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Minimally worse | 4 Participants |
| Perampanel 8mg | Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT | Very much improved | 4 Participants |
Secondary
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period
If acetaminophen was not reported on the Pain Therapy CRF or on the Concomitant Medication CRF, it was assumed that the subject did not use rescue analgesic medication.
Time frame: Baseline to Week 15
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | No (Did not use rescue analgesic medication) | 60 Participants |
| Placebo | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Yes (Used rescue analgesic medication) | 13 Participants |
| Perampanel 2mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | No (Did not use rescue analgesic medication) | 63 Participants |
| Perampanel 2mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Yes (Used rescue analgesic medication) | 9 Participants |
| Perampanel 4mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Yes (Used rescue analgesic medication) | 10 Participants |
| Perampanel 4mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | No (Did not use rescue analgesic medication) | 59 Participants |
| Perampanel 6mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Yes (Used rescue analgesic medication) | 10 Participants |
| Perampanel 6mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | No (Did not use rescue analgesic medication) | 58 Participants |
| Perampanel 8mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | Yes (Used rescue analgesic medication) | 13 Participants |
| Perampanel 8mg | Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period | No (Did not use rescue analgesic medication) | 57 Participants |
Secondary
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores
HADS anxiety subscale score=sum of scores for 7 anxiety items, 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, 0 to 21. HADS depression subscale score=sum of scores for 7 depression items, 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, 0 to 21.
Time frame: Baseline and Week 15/EOT
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Anxiety | -0.5 Scores on a Scale | Standard Deviation 3.01 |
| Placebo | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Depression | -0.7 Scores on a Scale | Standard Deviation 2.72 |
| Perampanel 2mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Anxiety | -0.3 Scores on a Scale | Standard Deviation 2.85 |
| Perampanel 2mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Depression | -0.4 Scores on a Scale | Standard Deviation 2.43 |
| Perampanel 4mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Anxiety | -0.5 Scores on a Scale | Standard Deviation 3.43 |
| Perampanel 4mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Depression | 0.0 Scores on a Scale | Standard Deviation 3.16 |
| Perampanel 6mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Depression | 0.1 Scores on a Scale | Standard Deviation 3.42 |
| Perampanel 6mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Anxiety | -0.5 Scores on a Scale | Standard Deviation 2.89 |
| Perampanel 8mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Anxiety | -0.4 Scores on a Scale | Standard Deviation 2.71 |
| Perampanel 8mg | Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores | Depression | 0.2 Scores on a Scale | Standard Deviation 2.9 |
Secondary
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores
Short Form 36 Health Survey Questionnaire (SF-36) measuring limitations in Physical Components including physical activities, usual role activities (due to physical problems), measuring bodily pain, general health perceptions, and Mental Components including social activities, usual role activities (due to emotional problems), vitality (energy and fatigue. Each of the 8 domains are described by a score ranging from 0 to 100, for a range of total possible scores of 0-400 for physical and 0-400 for mental. Higher scores reflect better subject status.
Time frame: Baseline and Week 15/EOT
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Mental Component Score | -0.26 Scores on a Scale | Standard Deviation 9.14 |
| Placebo | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Physical Component Score | 4.32 Scores on a Scale | Standard Deviation 7.43 |
| Perampanel 2mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Physical Component Score | 1.57 Scores on a Scale | Standard Deviation 6.35 |
| Perampanel 2mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Mental Component Score | 0.40 Scores on a Scale | Standard Deviation 8.26 |
| Perampanel 4mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Mental Component Score | 0.06 Scores on a Scale | Standard Deviation 10.77 |
| Perampanel 4mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Physical Component Score | 1.67 Scores on a Scale | Standard Deviation 8.21 |
| Perampanel 6mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Physical Component Score | 1.59 Scores on a Scale | Standard Deviation 7.92 |
| Perampanel 6mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Mental Component Score | -1.90 Scores on a Scale | Standard Deviation 8.74 |
| Perampanel 8mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Physical Component Score | 0.89 Scores on a Scale | Standard Deviation 6.86 |
| Perampanel 8mg | Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores | Mental Component Score | -1.61 Scores on a Scale | Standard Deviation 9.56 |
Secondary
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for sleep interference (0=pain did not interfere with sleep, to 10=pain completely interfered with sleep \[unable to sleep\]). Based on modified BOCF.
Time frame: Baseline to Week 15/EOT
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | -2.17 Scores on a Scale | Standard Deviation 2.18 |
| Perampanel 2mg | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | -1.49 Scores on a Scale | Standard Deviation 2.11 |
| Perampanel 4mg | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | -1.08 Scores on a Scale | Standard Deviation 2.19 |
| Perampanel 6mg | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | -1.71 Scores on a Scale | Standard Deviation 2 |
| Perampanel 8mg | Change in Average Sleep Interference Scores From Baseline to Week 15/EOT | -1.15 Scores on a Scale | Standard Deviation 2.19 |
Secondary
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT
SF-MPQ sensory score = sum of intensity scores for descriptors 1-11 (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting). Each descriptor scored as 0=none, 1=mild, 2=moderate, or 3=severe. Range of possible sensory scores, 0 to 33, with a score of 33 being the most severe intensity.
Time frame: Baseline and Week 15/EOT
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | -5.6 Scores on a Scale | Standard Deviation 6.83 |
| Perampanel 2mg | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | -3.9 Scores on a Scale | Standard Deviation 6.93 |
| Perampanel 4mg | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | -4.8 Scores on a Scale | Standard Deviation 5.83 |
| Perampanel 6mg | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | -6.2 Scores on a Scale | Standard Deviation 6.91 |
| Perampanel 8mg | Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT | -2.9 Scores on a Scale | Standard Deviation 5.85 |
Secondary
Presence or Absence of Allodynia at Week 15/EOT
Investigators rated subjects' allodynia as mild, moderate, severe, or not present. The presence of allodynia (yes/no) at Week 15/EOT was analyzed.
Time frame: Week 15/EOT
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Presence or Absence of Allodynia at Week 15/EOT | Yes (Allodynia present) | 20 Participants |
| Placebo | Presence or Absence of Allodynia at Week 15/EOT | No (Allodynia absent) | 47 Participants |
| Perampanel 2mg | Presence or Absence of Allodynia at Week 15/EOT | Yes (Allodynia present) | 18 Participants |
| Perampanel 2mg | Presence or Absence of Allodynia at Week 15/EOT | No (Allodynia absent) | 45 Participants |
| Perampanel 4mg | Presence or Absence of Allodynia at Week 15/EOT | Yes (Allodynia present) | 19 Participants |
| Perampanel 4mg | Presence or Absence of Allodynia at Week 15/EOT | No (Allodynia absent) | 47 Participants |
| Perampanel 6mg | Presence or Absence of Allodynia at Week 15/EOT | No (Allodynia absent) | 48 Participants |
| Perampanel 6mg | Presence or Absence of Allodynia at Week 15/EOT | Yes (Allodynia present) | 17 Participants |
| Perampanel 8mg | Presence or Absence of Allodynia at Week 15/EOT | Yes (Allodynia present) | 17 Participants |
| Perampanel 8mg | Presence or Absence of Allodynia at Week 15/EOT | No (Allodynia absent) | 44 Participants |
Secondary
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period
Based on data reported on the End of Study case report form (CRF): If a subject terminated the study early during the Double-blind Dosing Period due to 'lack of therapeutic efficacy,' the subject was counted as a withdrawal due to treatment failure.
Time frame: Baseline and Week 15
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Yes (withdrawn) | 0 Participants |
| Placebo | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | No (Not withdrawn) | 73 Participants |
| Perampanel 2mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Yes (withdrawn) | 1 Participants |
| Perampanel 2mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | No (Not withdrawn) | 71 Participants |
| Perampanel 4mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Yes (withdrawn) | 1 Participants |
| Perampanel 4mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | No (Not withdrawn) | 68 Participants |
| Perampanel 6mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | No (Not withdrawn) | 67 Participants |
| Perampanel 6mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Yes (withdrawn) | 1 Participants |
| Perampanel 8mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | Yes (withdrawn) | 1 Participants |
| Perampanel 8mg | Withdrawal Due to Treatment Failure During Double-Blind Dosing Period | No (Not withdrawn) | 69 Participants |