CClinicalTrials.gg
Sign In
CompletedNCT00505284Updated Jul 11, 2014Results posted

An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy

A Phase 2/3 interventional study of Placebo and E2007 (2 mg) in Diabetic Neuropathy, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Eisai Inc. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.

Read the 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.

02

Conditions studied

  • Diabetic Neuropathy

Keywords

  • Diabetic neuropathy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 352 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
352 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Perampanel 2mg

    Drug: E2007 (2 mg)

  • Active comparator
    Perampanel 4mg

    Drug: E2007 (4 mg)

  • Active comparator
    Perampanel 6mg

    Drug: E2007 (6 mg)

  • Active comparator
    Perampanel 8mg

    Drug: E2007 (8 mg)

Interventions

  • DrugPlacebo

    Placebo tablets, once daily, for 15 weeks (taken orally).

  • DrugE2007 (2 mg)

    Perampanel, 2 mg once daily, for 15 weeks (taken orally).

    Also known as: Perampanel

  • DrugE2007 (4 mg)

    Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).

    Also known as: Perampanel

  • 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).

    Also known as: Perampanel

  • 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).

    Also known as: Perampanel

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Results

Posted Feb 8, 2013

Participant flow

Participant flow — Overall Study
MilestonePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Started7372696870
Completed6356574937
Not completed1016121933
Withdrew: Adverse event3791422
Withdrew: Protocol violation01100
Withdrew: Withdrawal by subject26106
Withdrew: Lack of efficacy01111
Withdrew: Physician decision01000
Withdrew: Other50044

Outcome measures

PrimaryChange 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
Reported as:
Mean · Scores on a Scale
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)-2.22 ± 2.19-1.73 ± 2.34-1.30 ± 2.18-1.85 ± 2.01-1.18 ± 2.00
PrimaryResponder 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
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Responders (Yes)56.336.632.439.431.9
Non-responders (No)43.763.467.660.668.1
PrimaryResponder 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
Reported as:
Number · Percentage of Participants
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
Percentage of ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Responders (Yes)3823.922.130.318.8
Non-responders (No)6276.177.969.781.2
PrimaryMean 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
Reported as:
Mean · Scores on a Scale
Mean Change in Average Pain Scores From Baseline at Each Study Week
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Week 1-0.58 ± 1.46-0.71 ± 1.33-0.58 ± 1.39-0.79 ± 1.44-0.72 ± 1.33
Week 2-0.87 ± 1.65-1.09 ± 1.53-0.80 ± 1.55-1.19 ± 1.71-1.05 ± 1.52
Week 3-1.19 ± 1.85-1.33 ± 1.64-0.91 ± 1.67-1.53 ± 1.92-1.22 ± 1.75
Week 4-1.46 ± 1.73-1.33 ± 2.01-1.10 ± 1.93-1.75 ± 1.99-1.38 ± 1.97
Week 5-1.49 ± 1.71-1.55 ± 2.21-1.12 ± 2.08-1.93 ± 1.96-1.56 ± 1.94
Week 6-1.73 ± 1.81-1.70 ± 2.17-1.31 ± 2.12-2.03 ± 2.14-1.58 ± 2.11
Week 7-1.99 ± 1.96-1.84 ± 2.10-1.50 ± 2.04-2.31 ± 2.32-1.80 ± 1.98
Week 8-1.91 ± 2.01-1.86 ± 2.05-1.72 ± 2.20-2.19 ± 2.23-1.71 ± 2.18
Week 9-2.19 ± 2.10-1.86 ± 2.14-1.76 ± 2.19-2.28 ± 2.12-2.01 ± 2.31
Week 10-2.30 ± 1.96-1.88 ± 2.19-1.84 ± 2.12-2.04 ± 1.98-1.92 ± 2.08
Week 11-2.39 ± 2.03-1.98 ± 2.20-1.85 ± 2.14-2.10 ± 2.09-1.95 ± 2.06
Week 12-2.46 ± 1.99-1.81 ± 2.31-1.76 ± 2.16-2.13 ± 2.11-1.91 ± 2.16
Week 13-2.36 ± 2.00-1.80 ± 2.16-1.62 ± 2.29-2.23 ± 1.99-2.01 ± 2.17
Week 14-2.30 ± 2.17-1.84 ± 2.31-1.56 ± 2.27-2.25 ± 2.00-1.89 ± 2.19
Week 15-2.39 ± 2.23-1.99 ± 2.39-1.58 ± 2.16-2.36 ± 1.91-1.93 ± 2.23
Week 16-2.40 ± 2.38-2.49 ± 2.20-1.50 ± 2.12-1.87 ± 2.12-1.88 ± 2.01
Week 17NA ± NA-5.50 ± 3.33NA ± NANA ± NA0.71 ± NA
Last On-Treatment Value-2.24 ± 2.18-1.79 ± 2.32-1.48 ± 2.23-2.41 ± 2.15-1.69 ± 2.24
SecondaryChange 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
Reported as:
Mean · Scores on a Scale
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Change in Average Sleep Interference Scores From Baseline to Week 15/EOT-2.17 ± 2.18-1.49 ± 2.11-1.08 ± 2.19-1.71 ± 2.00-1.15 ± 2.19
SecondaryChange 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
Reported as:
Mean · Scores on a Scale
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT-5.6 ± 6.83-3.9 ± 6.93-4.8 ± 5.83-6.2 ± 6.91-2.9 ± 5.85
SecondaryAnalysis 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
Reported as:
Number · Participants
Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT
ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Very much improved93434
Much improved171315148
Minimally improved1818201310
No change1824242831
Minimally worse33334
Much worse11011
SecondaryChange 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
Reported as:
Mean · Scores on a Scale
Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Physical Component Score4.32 ± 7.431.57 ± 6.351.67 ± 8.211.59 ± 7.920.89 ± 6.86
Mental Component Score-0.26 ± 9.140.40 ± 8.260.06 ± 10.77-1.90 ± 8.74-1.61 ± 9.56
SecondaryChange 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
Reported as:
Mean · Scores on a Scale
Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores
Scores on a ScalePlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Anxiety-0.5 ± 3.01-0.3 ± 2.85-0.5 ± 3.43-0.5 ± 2.89-0.4 ± 2.71
Depression-0.7 ± 2.72-0.4 ± 2.430.0 ± 3.160.1 ± 3.420.2 ± 2.90
SecondaryWithdrawal 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
Reported as:
Number · Participants
Withdrawal Due to Treatment Failure During Double-Blind Dosing Period
ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Yes (withdrawn)01111
No (Not withdrawn)7371686769
SecondaryPresence 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
Reported as:
Number · Participants
Presence or Absence of Allodynia at Week 15/EOT
ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Yes (Allodynia present)2018191717
No (Allodynia absent)4745474844
SecondaryAnalysis 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
Reported as:
Number · Participants
Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period
ParticipantsPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
Yes (Used rescue analgesic medication)139101013
No (Did not use rescue analgesic medication)6063595857

Adverse events

Collected over Treatment-emergent adverse events (TEAEs): started on or after (or before if TEAE worsened in severity after first dose) the day of first dose of double-blind study drug up to 30 days after the last dose of double-blind study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—2/71 (2.8%)26/71 (36.6%)
Perampanel 2mg—2/71 (2.8%)30/71 (42.3%)
Perampanel 4mg—2/68 (2.9%)33/68 (48.5%)
Perampanel 6mg—8/67 (11.9%)40/67 (59.7%)
Perampanel 8mg—8/68 (11.8%)38/68 (55.9%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
SepsisInfections and infestations0/711/710/682/670/68
AnaemiaBlood and lymphatic system disorders0/710/710/681/670/68
Atrial FibrillationCardiac disorders0/710/710/681/671/68
Cardiac Failure CongestiveCardiac disorders0/710/711/681/670/68
TachycardiaCardiac disorders0/710/710/681/670/68
CellulitisInfections and infestations0/710/710/681/670/68
LabyrinthitisInfections and infestations0/710/710/681/670/68
OsteomyelitisInfections and infestations0/710/710/681/670/68
SinusitisInfections and infestations0/710/710/681/670/68
Wound Infection StaphylococcalInfections and infestations0/710/710/681/670/68
Most frequent other events
Showing 10 of 20
Most frequent other events
EventPlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mg
DizzinessNervous system disorders1/716/712/6815/6715/68
SomnolenceNervous system disorders2/712/719/685/6711/68
FallInjury, poisoning and procedural complications2/712/714/687/677/68
Pain in ExtremityMusculoskeletal and connective tissue disorders3/710/712/686/671/68
NauseaGastrointestinal disorders2/714/712/685/675/68
Gait DisturbanceGeneral disorders0/712/713/685/673/68
Oedema PeripheralGeneral disorders5/713/715/683/672/68
NasopharyngitisInfections and infestations3/712/715/681/672/68
ContusionInjury, poisoning and procedural complications3/711/713/684/675/68
Upper Respiratory Tract InfectionInfections and infestations5/713/712/683/674/68

Baseline characteristics

Age, Customized
Age, Customized(Participants)PlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mgTotal
<65 years5050403441215
>=65 years2121283327130
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mgTotal
Female3727283425151
Male3444403343194
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)PlaceboPerampanel 2mgPerampanel 4mgPerampanel 6mgPerampanel 8mgTotal
White5656566060288
Black81144633
Asian412007
Other3363217
08

Study locations

1 site
  • Dr. Richard Blonsky
    Chicago, Illinois 60610, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00505284
Lead sponsor
Eisai Inc.
Collaborators
Eisai Limited
Responsible party
Sponsor
First posted
Jul 23, 2007
Start date
Jun 2007
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Feb 8, 2013
Last update
Jul 11, 2014

Study contacts

Antonio Laurenza, M.D.
study director · Eisai Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Nervous System Diseases→

Other studies from this sponsor

Eisai Inc.

Start the discussion