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CompletedNCT00592774Updated Feb 15, 2013Results posted

Dose-Tolerability Titration Study to Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)

A Phase 2 interventional study of E2007 (perampanel) and Placebo in Neuralgia, sponsored by Eisai Inc.. Completed at 47 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

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

Phase
Phase 2
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine the efficacy and safety of Perampanel (E2007) in patients with Post-Herpetic Neuralgia (PHN).

02

Conditions studied

  • Neuralgia

Keywords

  • Post-Herpetic Neuralgia
  • PHN)
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 146 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia 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 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. Females should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception. Acceptable contraception includes: abstinence, a barrier method plus spermicide, or intrauterine device [IUD]. Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD). Contraceptive use must start at least 1 month before Visit 1, be practiced throughout the entire study period, and continue for 1 month after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (β-hCG) at Visit 1, and a negative urine pregnancy test at Baseline Visit 2.
  3. PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
  4. Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
  5. Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Visit 1 and Baseline (Visit 2 prior to randomization).
  6. Have completed the patient diary for at least 6 of the 7 days prior to Visit 2 (Baseline).
  7. Average daily pain score of ≥ 4, on 11-point Likert scale during the 7 days prior to randomization [from the diaries].

  8. Reliable and willing and able to cooperate with all study procedures, including the following examples:

    • Accurately entering the diary on a daily basis
    • Returning for study visits on the required dates
    • Accurately and reliably reporting symptoms (including treatment-emergent signs and symptoms)
    • Taking study drug as required by protocol

  9. Be on stable analgesic treatment (same medication(s)) or stable nonpharmacological pain treatment for at least 4 weeks prior to Visit 1 and remain on this stable treatment throughout the study. Nonpharmacologic pain treatment includes the following:

    • relaxation/hypnosis
    • physical or occupational therapy
    • mental-health counseling
    • acupuncture
    • injections
    • blocks, etc.
    • Episodic or periodic pharmacologic treatments such as monthly injections for treatment of pain (eg, local anesthetics) will not be permitted.
    • Up to 4 g of acetaminophen/day is permitted as rescue medication, as needed, during the trial.

Exclusion criteria

Exclusion Criteria:

Patients with any of the following are to be excluded:

  1. Any condition that could interfere with the conduct of the trial or confound efficacy evaluations including the following examples: pain or neuropathy from another cause (including painful diabetic neuropathy), such as central pain, radiculopathy, painful arthritis, etc.
  2. Motivation by secondary gain, or where there is a negative-incentive to achieving pain and functional relief (eg, litigation). This will be determined from the medical history and is at the discretion of the investigator.
  3. Inability to cooperate with protocol, for any reason.

  4. Clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine, or immunologic, including patients with any of the following broad disease categories:

    1. Systemic infections (eg, human immunodeficiency virus [HIV], hepatitis, tuberculosis [TB], syphilis); lack of appropriate medical history of these conditions is acceptable,
    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 (the exception is fully treated, non-melanoma skin cancer such as basal cell carcinoma),
    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,
    7. History of major systemic allergy such as anaphylactoid reactions or Stevens-Johnson syndrome (however, patients with limited allergies such as contact dermatitis or minor allergy to penicillin are acceptable).

  5. Any of the following laboratory abnormalities at Visit 1:

    1. Clinically significant ECG abnormality, including prolonged QTc (defined as QTcB > 450 msec),
    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN),
    3. Clinically significant abnormal white blood cell (WBC), absolute neutrophil, or platelet count values,
    4. Any other clinically significant laboratory value.
  6. Exposure to an investigational drug within the 30 days prior to Visit 1 or exposure ever to perampanel.
  7. Females who are pregnant, lactating, or planning to become pregnant during the study.
  8. Use of any medication known to be a strong inducer of CYP3A4 activity within 4 weeks prior to Visit 1; use of CYP3A4 inducers is prohibited for the entire study duration.
05

Study design

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

Study arms

  • Placebo comparator
    Placebo Cohort 1

    Drug: Placebo

  • Experimental
    Perampanel Cohort 1, 3-week Titration

    Drug: E2007 (perampanel)

  • Experimental
    Placebo Cohort 2

    Drug: Placebo

  • Experimental
    Perampanel Cohort 2, 1-week Titration

    Drug: E2007 (perampanel)

  • Experimental
    Perampanel Cohort 2, 2- Week Titration

    Drug: E2007 (perampanel)

Interventions

  • DrugE2007 (perampanel)

    2 mg titrated up to 8 mg maximum; taken once daily.

    Also known as: perampanel

  • DrugPlacebo

    2 mg titrated up to 8 mg maximum; taken once daily.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    Time frame: Week 1 through Week 16

Secondary outcomes

  1. 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

  2. Patient Global Impression of Change (PGIC) at Week 15/EOT

    Changes were calculated using the modified BOCF method

    Time frame: Week 15

  3. Clinician Global Impression of Change (CGIC) at Week 15/EOT

    Changes were calculated using the modified BOCF method

    Time frame: Week 15

  4. 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

  5. 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

  6. 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

07

Results

Posted Feb 15, 2013

Participant flow

Participant flow — Overall Study
MilestonePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Started2653222223
Completed15211889
Not completed113241414
Withdrew: Adverse event5192148
Withdrew: Protocol violation01001
Withdrew: Withdrawal by subject37000
Withdrew: Lack of efficacy33002
Withdrew: Physician decision01101
Withdrew: Other01102

Outcome measures

PrimaryChange 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
Reported as:
Mean · Scores on a scale
Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)
Scores on a scalePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)-0.55 ± 1.56-1.30 ± 2.13-0.95 ± 1.77-0.50 ± 1.35-1.01 ± 1.52
PrimaryResponder 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
Reported as:
Number · Percentage of Participants
Responder Rate: Subjects With at Least 30 Percent Reduction in Pain
Percentage of ParticipantsPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Responders (Yes)19.228.322.713.626.1
Non-Responders (No)80.871.777.386.473.9
PrimaryResponder 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
Reported as:
Number · Percentage of Participants
Responder Rate: Subjects With at Least 50 Percent Reduction in Pain
Percentage of ParticipantsPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Responders (Yes)11.520.813.69.113.0
Non-Responders (No)88.579.286.490.987.0
PrimaryChange 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.

Time frame:
Week 1 through Week 16
Reported as:
Mean · Scores on a scale
Change From Baseline in Average Pain Scores by Week
Scores on a scalePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Week 1-0.25 ± 0.66-0.35 ± 1.03-0.43 ± 0.88-0.44 ± 0.75-0.55 ± 0.71
Week 2-0.39 ± 1.11-0.60 ± 1.29-0.64 ± 1.19-0.86 ± 1.19-0.74 ± 1.23
Week 3-0.68 ± 1.20-1.01 ± 1.61-0.74 ± 1.31-1.22 ± 1.53-1.19 ± 1.32
Week 4-0.82 ± 1.70-1.29 ± 1.88-0.89 ± 1.48-1.64 ± 1.68-1.68 ± 1.49
Week 5-1.13 ± 1.93-1.46 ± 1.93-0.74 ± 1.58-1.68 ± 1.93-1.23 ± 1.43
Week 6-0.81 ± 1.37-1.39 ± 1.96-0.92 ± 1.66-1.53 ± 2.23-1.31 ± 1.43
Week 7-0.80 ± 1.57-1.74 ± 2.12-1.21 ± 1.74-1.52 ± 2.32-1.50 ± 1.67
Week 8-0.68 ± 1.43-1.92 ± 2.32-1.03 ± 1.66-1.46 ± 2.21-1.68 ± 2.01
Week 9-0.53 ± 1.43-1.99 ± 2.34-1.08 ± 1.79-1.24 ± 1.88-1.73 ± 2.24
Week 10-0.88 ± 1.60-2.17 ± 2.30-1.14 ± 1.92-1.48 ± 1.71-1.36 ± 2.38
Week 11-0.96 ± 1.67-2.33 ± 2.28-1.01 ± 1.64-1.98 ± 1.63-1.46 ± 2.51
Week 12-0.99 ± 1.78-2.52 ± 2.36-1.01 ± 1.67-1.82 ± 1.43-1.40 ± 2.55
Week 13-0.80 ± 1.72-2.13 ± 2.31-1.05 ± 1.78-1.77 ± 1.88-1.96 ± 1.92
Week 14-1.00 ± 1.85-2.38 ± 2.27-1.17 ± 1.83-1.46 ± 1.72-2.19 ± 1.91
Week 15-0.88 ± 1.96-2.42 ± 2.40-1.17 ± 1.91-1.32 ± 2.00-2.09 ± 1.77
Week 16-1.79 ± 1.11-3.17 ± 2.18-0.65 ± 1.93-0.88 ± 1.97-0.95 ± 1.39
SecondaryChange 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
Reported as:
Mean · Scores on a scale
Change From Baseline to Week 15/EOT in Average Sleep Interference Scores
Scores on a scalePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Change From Baseline to Week 15/EOT in Average Sleep Interference Scores-0.58 ± 1.30-0.46 ± 1.92-1.16 ± 1.60-0.48 ± 1.29-0.75 ± 1.41
SecondaryPatient Global Impression of Change (PGIC) at Week 15/EOT

Changes were calculated using the modified BOCF method

Time frame:
Week 15
Reported as:
Number · Participants
Patient Global Impression of Change (PGIC) at Week 15/EOT
ParticipantsPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Very much improved04111
Much improved38421
Minimally improved12324
No change1327111315
Minimally worse20101
Much worse11010
Very much worse00000
SecondaryClinician Global Impression of Change (CGIC) at Week 15/EOT

Changes were calculated using the modified BOCF method

Time frame:
Week 15
Reported as:
Number · Participants
Clinician Global Impression of Change (CGIC) at Week 15/EOT
ParticipantsPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Very much improved13202
Much improved18222
Minimally improved26233
No change1628141615
Minimally worse10000
Much worse00000
Very much worse00000
SecondaryChange 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
Reported as:
Mean · Scores on a scale
Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)
Scores on a scalePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)-0.2 ± 1.310.0 ± 3.250.1 ± 2.900.0 ± 1.28-0.1 ± 2.35
SecondaryChange 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
Reported as:
Mean · Scores on a scale
Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)
Scores on a scalePlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)-0.1 ± 1.510.1 ± 2.11-0.6 ± 2.280.2 ± 2.66-0.3 ± 1.49
SecondaryAnalysis 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
Reported as:
Number · Participants
Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)
ParticipantsPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Yes2247171719
No46554

Adverse events

Collected over Adverse events (AEs) were collected from the time the patient signed the informed consent form until 30 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Cohort 1—1/26 (3.8%)11/26 (42.3%)
Perampanel Cohort 1, 3-week Titration—7/53 (13.2%)36/53 (67.9%)
Placebo Cohort 2—2/22 (9.1%)14/22 (63.6%)
Perampanel Cohort 2, 1-week Titration—1/22 (4.5%)18/22 (81.8%)
Perampanel Cohort 2, 2- Week Titration—1/23 (4.3%)16/23 (69.6%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
Coronary artery diseaseCardiac disorders0/260/531/220/220/23
Gastric ulcer perforationGastrointestinal disorders0/260/531/220/220/23
PeritonitisGastrointestinal disorders0/260/531/220/220/23
Ankle fractureInjury, poisoning and procedural complications0/260/530/221/220/23
Carotid artery stenosisNervous system disorders0/260/530/220/221/23
Carotid artery occlusionNervous system disorders1/260/530/220/220/23
Urinary tract infectionInfections and infestations0/262/530/220/220/23
Angina pectorisCardiac disorders0/261/530/220/220/23
Non-cardiac chest painGeneral disorders0/261/530/220/220/23
VestibulitisGeneral disorders0/261/530/220/220/23
Most frequent other events
Showing 10 of 23
Most frequent other events
EventPlacebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week Titration
DizzinessNervous system disorders8/2622/531/2212/228/23
Gait disturbanceGeneral disorders0/262/530/227/222/23
SomnolenceNervous system disorders1/269/534/222/225/23
DysarthriaNervous system disorders0/262/530/224/221/23
Gastrooesophageal reflux diseaseGastrointestinal disorders1/262/533/220/221/23
FatigueGeneral disorders1/261/531/223/222/23
HeadacheNervous system disorders2/264/531/223/221/23
Confusional statePsychiatric disorders0/260/530/223/220/23
Vision blurredEye disorders0/260/530/222/221/23
ConstipationGastrointestinal disorders1/261/532/221/220/23

Baseline characteristics

Age, Customized
Age, Customized(Participants)Placebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week TitrationTotal
<65 years101562942
≥65 to <75 years81554335
≥75 years82311161169
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week TitrationTotal
Female11318111475
Male15221411971
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo Cohort 1Perampanel Cohort 1, 3-week TitrationPlacebo Cohort 2Perampanel Cohort 2, 1-week TitrationPerampanel Cohort 2, 2- Week TitrationTotal
White2543202118127
Black170019
Asian000033
Other032117
08

Study locations

47 sites
  • Peoria, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Boulder, Colorado, United States
  • Denver, Colorado, United States
  • Milford, Connecticut, United States
  • Boca Raton, Florida, United States
  • Bradenton, Florida, United States
  • Daytona Beach, Florida, United States
  • Delray Beach, Florida, United States
  • Fort Myers, Florida, United States
  • Ft. Lauderdale, Florida, United States
  • Kissimmee, Florida, United States
  • Largo, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Palm Beach Gardens, Florida, United States
  • Sarasota, Florida, United States
  • St. Petersburg, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Pain and Rehabilitation Clinic of Chicago
    Chicago, Illinois 60610, United States
  • Chicago, Illinois, United States
  • Towson, Maryland, United States
  • Boston, Massachusetts, United States
  • West Yarmouth, Massachusetts, United States
  • Southfield, Michigan, United States
  • Missoula, Montana, United States
  • Las Vegas, Nevada, United States
  • Brooklyn, New York, United States
  • High Point, North Carolina, United States
  • Winston Salem, North Carolina, United States
  • Kettering, Ohio, United States
  • Bensalem, Pennsylvania, United States
  • Norristown, Pennsylvania, United States
  • Warwick, Rhode Island, United States
  • Dallas, Texas, United States
  • Kelowna, British Columbia, Canada
  • Sarnia, Ontario, Canada
  • Toronto, Ontario, Canada
  • Pointe Claire, Quebec, Canada
  • Saskatoon, Saskatchewan, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00592774
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Jan 14, 2008
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Mar 2009
Results posted
Feb 15, 2013
Last update
Feb 15, 2013

Study contacts

Allison Mann, MD
study director · Eisai Inc.
View the source record on ClinicalTrials.gov ↗

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

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Discussion

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