NeuralgiaPhase 2NCT00592774

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

A Phase 2 study testing E2007 (perampanel) in people with Neuralgia, run by Eisai Inc. at 47 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuralgia
What is being tested?: E2007 (perampanel)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 146 participants
Where: 47 sitesin 2 countries
Study dates: Jan 2008to Mar 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To be included, patients must meet the following:
Provide written informed consent, prior to entering the study or undergoing any study procedures.
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.
PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
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).

Show all 22Show fewer

Have completed the patient diary for at least 6 of the 7 days prior to Visit 2 (Baseline).
Average daily pain score of ≥ 4, on 11-point Likert scale during the 7 days prior to randomization [from the diaries].
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
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.

Who cannot join

Patients with any of the following are to be excluded:
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.
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.
Inability to cooperate with protocol, for any reason.
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:
Systemic infections (eg, human immunodeficiency virus [HIV], hepatitis, tuberculosis [TB], syphilis); lack of appropriate medical history of these conditions is acceptable,

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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,
History of acute coronary syndrome within the past 12 months,
Active cancer within the previous 5 years (the exception is fully treated, non-melanoma skin cancer such as basal cell carcinoma),
Systemic chemotherapy or immunotherapy within the past 5 years,
History of major depression, bipolar disease, psychosis or suicidal ideation or attempts within the past 5 years,
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).
Any of the following laboratory abnormalities at Visit 1:
Clinically significant ECG abnormality, including prolonged QTc (defined as QTcB > 450 msec),
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN),
Clinically significant abnormal white blood cell (WBC), absolute neutrophil, or platelet count values,
Any other clinically significant laboratory value.
Exposure to an investigational drug within the 30 days prior to Visit 1 or exposure ever to perampanel.
Females who are pregnant, lactating, or planning to become pregnant during the study.
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.

Trial locations and contacts

47 sites in 2 countries.

Country

City, postcode or hospital

47 sites in 2 countries

United States42 sites

Study site
Bensalem, Pennsylvania
Study site
Boca Raton, Florida
Study site
Boston, Massachusetts
Study site
Boulder, Colorado
Study site
Bradenton, Florida
Study site
Brooklyn, New York
Pain and Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Daytona Beach, Florida
Study site
Delray Beach, Florida
Study site
Denver, Colorado
Study site
Fort Lauderdale, Florida
Study site
Fort Myers, Florida
Study site
High Point, North Carolina
Study site
Kettering, Ohio
Study site
Kissimmee, Florida
Study site
Largo, Florida
Study site
Las Vegas, Nevada
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Milford, Connecticut
Study site
Missoula, Montana
Study site
Naples, Florida
Study site
Norristown, Pennsylvania
Study site
Orlando, Florida
Study site
Palm Beach Gardens, Florida
Study site
Peoria, Arizona
Study site
Sacramento, California
Study site
San Diego, California
Study site
San Francisco, California
Study site
Sarasota, Florida
Study site
Southfield, Michigan
Study site
St. Petersburg, Florida
Study site
Sunrise, Florida
Study site
Tampa, Florida
Study site
Towson, Maryland
Study site
Tucson, Arizona
Study site
Warwick, Rhode Island
Study site
West Yarmouth, Massachusetts
Study site
Winston-Salem, North Carolina

Other trials in United States

Canada5 sites

Study site
Kelowna, British Columbia
Study site
Pointe-Claire, Quebec
Study site
Sarnia, Ontario
Study site
Saskatoon, Saskatchewan
Study site
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Tolerability Titration Study To Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)

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

Conditions: Neuralgia
Being tested: E2007 (perampanel), Placebo
Keywords: Post-Herpetic Neuralgia, PHN)
Medical subject headings: Neuralgia, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E2007 (perampanel)Drug
Also called perampanel
2 mg titrated up to 8 mg maximum; taken once daily.
PlaceboDrug
2 mg titrated up to 8 mg maximum; taken once daily.

Study groups in NCT00592774
Study group	Role	What they receive
Placebo Cohort 1	Placebo comparator	Not described Receives: Drug: Placebo
Perampanel Cohort 1, 3-week Titration	Experimental	Not described Receives: Drug: E2007 (perampanel)
Placebo Cohort 2	Experimental	Not described Receives: Drug: Placebo
Perampanel Cohort 2, 1-week Titration	Experimental	Not described Receives: Drug: E2007 (perampanel)
Perampanel Cohort 2, 2- Week Titration	Experimental	Not described Receives: Drug: E2007 (perampanel)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 15
Responder Rate: Subjects With at Least 30 Percent Reduction in Pain
A responder was a participant with at least 30 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Measured: Baseline and Week 15
Responder Rate: Subjects With at Least 50 Percent Reduction in Pain
A responder was a participant with at least 50 percent reduction in average pain scores, using modified BOCF, based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain score for baseline was calculated using the average of the last 7 scores prior to randomization, and the average pain score for Week 15 was computed using the average of the last 7 on-treatment scores prior to Week 15, and they were reported by treatment group.
Measured: Baseline and Week 15
Change From Baseline in Average Pain Scores by Week
Change from baseline in average pain scores by week based on pain intensity (11-point Likert-type numerical scale where 0=no pain and 10=worst possible pain), reported by the subjects in a daily diary. The average pain scores were calculated as the average of available scores in each week, and were reported by treatment group.
Measured: Week 1 through Week 16

Secondary outcomes (6)

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.
Measured: Baseline and Week 15
Patient Global Impression of Change (PGIC) at Week 15/EOT
Changes were calculated using the modified BOCF method
Measured: Week 15
Clinician Global Impression of Change (CGIC) at Week 15/EOT
Changes were calculated using the modified BOCF method
Measured: Week 15
Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)
The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-A consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse anxiety. Range of possible HADS anxiety subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).
Measured: Baseline and Week 15
Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)
The HADS (Hospital Anxiety and Depression Scale) is a widely used, self-reported, 14-item instrument that measures the presence and severity of anxiety and depression. It consists of 2 subscales; a 7-item anxiety subscale (HADS-A) and a 7-item depression subscale (HADS-D). HADS-D consists of a 7-item scale, each scored on a 4-pt scale (0, 1, 2, or 3), where a higher score indicates worse depression. Range of possible HADS depression subscale scores is 0 to 21, and normal=(0-7), mild=(8-10), moderate=(11-14), and severe=(15-21).
Measured: Baseline and Week 15
Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)
Allodynia is defined as a painful reaction to a non-painful stimulus.
Measured: Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2009

First posted14 Jan 2008 (estimated)
Study startJan 2008
Primary completionDec 2008
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeuralgiaStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00592774
Sponsor's protocol ID: E2007-A001-218
Status last verified: Feb 2013
First submitted: 3 Jan 2008
Last updated: 15 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuralgia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Tolerability Titration Study To Evaluate The Efficacy And Safety Of Perampanel (E2007) In Patients With Post-Herpetic Neuralgia (PHN)
ClinicalTrials.gov ID: NCT00592774
Acronym / sponsor ID: E2007-A001-218
Conditions: Neuralgia
Keywords: Post-Herpetic Neuralgia, PHN)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Dec 2008 (actual)
Study completion: Mar 2009 (actual)
First posted: 14 Jan 2008 (estimated)
Results: Posted 15 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo Cohort 1	Placebo comparator	Drug: Placebo
Perampanel Cohort 1, 3-week Titration	Experimental	Drug: E2007 (perampanel)
Placebo Cohort 2	Experimental	Drug: Placebo
Perampanel Cohort 2, 1-week Titration	Experimental	Drug: E2007 (perampanel)
Perampanel Cohort 2, 2- Week Titration	Experimental	Drug: E2007 (perampanel)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Provide written informed consent, prior to entering the study or undergoing any study procedures.
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.
PHN of at least 6 months duration; the onset of PHN is defined as the time from healing of herpes zoster skin lesions.
Pain over the past 6 months, and not in a clinically identifiable improving or worsening trend, based on medical history.
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).

Key exclusion criteria (20 listed)

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.
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.
Inability to cooperate with protocol, for any reason.
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:
Any of the following laboratory abnormalities at Visit 1:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E2007 (perampanel)Also: perampanel2 mg titrated up to 8 mg maximum; taken once daily.	Drug	Perampanel Cohort 1, 3-week Titration, Perampanel Cohort 2, 1-week Titration, Perampanel Cohort 2, 2- Week Titration
Placebo2 mg titrated up to 8 mg maximum; taken once daily.	Drug	Placebo Cohort 1, Placebo Cohort 2

Primary outcome

Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)
Time frame: Baseline and Week 15
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.
Responder Rate: Subjects With at Least 30 Percent Reduction in Pain
Time frame: Baseline and Week 15
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.
Responder Rate: Subjects With at Least 50 Percent Reduction in Pain
Time frame: Baseline and Week 15
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.
Change From Baseline in Average Pain Scores by Week
Time frame: Week 1 through Week 16
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.

6 secondary outcomes

Change From Baseline to Week 15/EOT in Average Sleep Interference Scores
Time frame: Baseline and Week 15
Patient Global Impression of Change (PGIC) at Week 15/EOT
Time frame: Week 15
Clinician Global Impression of Change (CGIC) at Week 15/EOT
Time frame: Week 15
Change From Baseline to Week 15/EOT in HADS Anxiety Subscale Scores (Modified BOCF)
Time frame: Baseline and Week 15
Change From Baseline to Week 15/EOT in HADS Depression Subscale Scores (Modified BOCF)
Time frame: Baseline and Week 15
Analysis of Allodynia (Present/Not Present) at Week 15/EOT- by Treatment Groups ITT Population (Modified BOCF)
Time frame: Week 15

Results and safety

Results posted to the registry on 15 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Cohort 1	26	15
Perampanel Cohort 1, 3-week Titration	53	21
Placebo Cohort 2	22	18
Perampanel Cohort 2, 1-week Titration	22	8
Perampanel Cohort 2, 2- Week Titration	23	9

Primary outcome: Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data)

Time frame: Baseline and Week 15. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Placebo Cohort 1 n = 26	Perampanel Cohort 1, 3-week Titration n = 53	Placebo Cohort 2 n = 22	Perampanel Cohort 2, 1-week Titration n = 22	Perampanel Cohort 2, 2- Week Titration n = 23
Value	-0.55 (1.56)	-1.30 (2.13)	-0.95 (1.77)	-0.50 (1.35)	-1.01 (1.52)

Population analysed: Intent-to-Treat (ITT) Population- group of subjects who were randomized, took study drug, and had at least 1 efficacy assessment at Baseline. The modified Baseline Observation Carried Forward (BOCF) method was used.

Primary outcome: Responder Rate: Subjects With at Least 30 Percent Reduction in Pain

Time frame: Baseline and Week 15. Number. Unit: Percentage of Participants

Measure	Placebo Cohort 1 n = 26	Perampanel Cohort 1, 3-week Titration n = 53	Placebo Cohort 2 n = 22	Perampanel Cohort 2, 1-week Titration n = 22	Perampanel Cohort 2, 2- Week Titration n = 23
Responders (Yes)	19.2	28.3	22.7	13.6	26.1
Non-Responders (No)	80.8	71.7	77.3	86.4	73.9

Population analysed: ITT Population (Modified BOCF)

Primary outcome: Responder Rate: Subjects With at Least 50 Percent Reduction in Pain

Time frame: Baseline and Week 15. Number. Unit: Percentage of Participants

Measure	Placebo Cohort 1 n = 26	Perampanel Cohort 1, 3-week Titration n = 53	Placebo Cohort 2 n = 22	Perampanel Cohort 2, 1-week Titration n = 22	Perampanel Cohort 2, 2- Week Titration n = 23
Responders (Yes)	11.5	20.8	13.6	9.1	13.0
Non-Responders (No)	88.5	79.2	86.4	90.9	87.0

Population analysed: ITT Population (Modified BOCF)

Primary outcome: Change From Baseline in Average Pain Scores by Week

Time frame: Week 1 through Week 16. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Placebo Cohort 1 n = 26	Perampanel Cohort 1, 3-week Titration n = 53	Placebo Cohort 2 n = 22	Perampanel Cohort 2, 1-week Titration n = 22	Perampanel Cohort 2, 2- Week Titration n = 23
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)

Population analysed: ITT Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Cohort 1	1 of 26 (3.8%)	11 of 26 (42.3%)	Not reported
Perampanel Cohort 1, 3-week Titration	7 of 53 (13.2%)	36 of 53 (67.9%)	Not reported
Placebo Cohort 2	2 of 22 (9.1%)	14 of 22 (63.6%)	Not reported
Perampanel Cohort 2, 1-week Titration	1 of 22 (4.5%)	18 of 22 (81.8%)	Not reported
Perampanel Cohort 2, 2- Week Titration	1 of 23 (4.3%)	16 of 23 (69.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Allison Mann, MD study director

Eisai Inc.

47 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2007 (perampanel) in people with Neuralgia, run by Eisai Inc. at 47 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Pain Scores to Week 15/ End of Treatment (EOT) (Including Modified BOCF Data) (time frame: Baseline and Week 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00592774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.