CompletedPhase 2/3

Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)

United States262 participantsStarted 2008-01

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Completed the preceding double-blind study End of Treatment (EOT) Visit no more than 12 weeks prior to Baseline (Visit 1) for the open-label study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor.
. Males and females ≥18 years of age. Female patients 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 (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \[IUD\]) for at least 1 month before the Baseline Visit (Visit 1) and for 1 month after the end of the study (Visit 16). They must also have a negative pregnancy test at Baseline (Visit 1). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) throughout the study.
. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.
. Is reliable, willing, and able to cooperate with the study procedures.
. Patients who discontinued early for any reason from the preceding double-blind study.
. Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.

Timeframe: Baseline and Week 48

Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.

Timeframe: Baseline and Week 48

Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48

Timeframe: Baseline and Week 48

Trial details

NCT IDNCT00592904

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-11

Results submitted2012-10-23

View on ClinicalTrials.gov More Neuralgia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Completed the preceding double-blind study End of Treatment (EOT) Visit no more than 12 weeks prior to Baseline (Visit 1) for the open-label study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor.
. Males and females ≥18 years of age. Female patients 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 (e.g., abstinence, a barrier method plus spermicide, or intrauterine device \[IUD\]) for at least 1 month before the Baseline Visit (Visit 1) and for 1 month after the end of the study (Visit 16). They must also have a negative pregnancy test at Baseline (Visit 1). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) throughout the study.
. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.
. Is reliable, willing, and able to cooperate with the study procedures.
. Patients who discontinued early for any reason from the preceding double-blind study.
. Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.

What they're measuring

Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.

Timeframe: Baseline and Week 48

Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.

Timeframe: Baseline and Week 48

Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48

Timeframe: Baseline and Week 48