NeuralgiaPhase 2/3NCT00592904

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

A Phase 2/3 study testing E2007 in people with Neuralgia, run by Eisai Inc. at 1 site in United States.

Completed

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

Trial 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). 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 262 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Jul 2011
Phase: Phase 2/3
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

Each patient must meet all of the following criteria to be enrolled in this study:
Met and continues to meet all inclusion and none of the exclusion criteria for the preceding PDN or PHN study and received study drug or placebo under double-blind conditions.
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.

Who cannot join

Patients who meet the following criterion will be excluded from this study:
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Chicago, Illinois, 60610

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)

Conditions: Neuralgia
Being tested: E2007
Keywords: Neuralgia, neuropathy
Medical subject headings: Neuralgia

What participants receive

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

E2007Drug
Also called Perampanel
Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).

Study groups in NCT00592904
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: E2007

What is being measured

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

Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.
Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
Measured: Baseline and Week 48
Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.
SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
Measured: Baseline and Week 48
Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48
Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).
Measured: Baseline and Week 48

Secondary outcomes (2)

Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].
Measured: Baseline and Week 48
Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT
Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.
Measured: Baseline and Week 48

Timeline

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

Jan 2008Jul 2011

First posted14 Jan 2008 (estimated)
Study startJan 2008
Primary completionNov 2009
Study completionJul 2011

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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 262 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00592904
Sponsor's protocol ID: E2007-G000-228
Other IDs: 2007-005495-13
Status last verified: Nov 2015
First submitted: 3 Jan 2008
Last updated: 21 Jan 2016
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 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
ClinicalTrials.gov ID: NCT00592904
Acronym / sponsor ID: E2007-G000-228
Conditions: Neuralgia
Keywords: Neuralgia, neuropathy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 262 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Nov 2009 (actual)
Study completion: Jul 2011 (actual)
First posted: 14 Jan 2008 (estimated)
Results: Posted 8 Feb 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: E2007

Who may qualify

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

Key inclusion criteria (6 listed)

Met and continues to meet all inclusion and none of the exclusion criteria for the preceding PDN or PHN study and received study drug or placebo under double-blind conditions.
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.

Key exclusion criteria (3 listed)

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.

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
E2007Also: PerampanelPerampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).	Drug	1

Primary outcome

Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.
Time frame: Baseline and Week 48
Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.
Time frame: Baseline and Week 48
SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48
Time frame: Baseline and Week 48
Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).

2 secondary outcomes

Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
Time frame: Baseline and Week 48
Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT
Time frame: Baseline and Week 48

Results and safety

Results posted to the registry on 8 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
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo	57	32
PDN: Prior Treatment of Perampanel	148	93
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo	27	10
PHN: Prior Treatment of Perampanel	30	19

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

Time frame: Baseline and Week 48. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo n = 57	PDN: Prior Treatment of Perampanel n = 147	Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo n = 27	PHN: Prior Treatment of Perampanel n = 30
Value	-10.5 (8.41)	-8.1 (9.65)	-9.0 (6.72)	-9.8 (10.19)

Population analysed: Intent-to-Treat (ITT) Population: All enrolled subjects (starting at Visit 1) who took at least 1 dose of study drug and had at least 1 efficacy assessment in this trial comprised the ITT Population. All efficacy analyses were performed on the ITT Population. One subject had a protocol violation after consenting and was withdrawn from treatment.

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

Time frame: Baseline and Week 48. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo n = 57	PDN: Prior Treatment of Perampanel n = 147	Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo n = 27	PHN: Prior Treatment of Perampanel n = 30
Value	-43.1 (23.17)	-33.7 (24.49)	-35.9 (24.55)	-35.4 (27.66)

Population analysed: ITT Population

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

Time frame: Baseline and Week 48. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo n = 57	PDN: Prior Treatment of Perampanel n = 147	Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo n = 27	PHN: Prior Treatment of Perampanel n = 30
Value	-0.9 (0.71)	-1.0 (1.24)	-1.1 (0.57)	-1.3 (1.29)

Population analysed: ITT Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent Adverse Events (TEAEs) are those that started on or after first dose of open-label study drug up to and including 30 days after the last dose of open-label study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	11 of 84 (13.1%)	72 of 84 (85.7%)	Not reported
Perampanel	25 of 178 (14%)	132 of 178 (74.2%)	Not reported
Painful Diabetic Neuropathy	31 of 205 (15.1%)	160 of 205 (78%)	Not reported
Post Herpetic Neuralgia	5 of 57 (8.8%)	44 of 57 (77.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neuralgia

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia

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.

Antonio Laurenza, M. D. study director

Eisai Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing E2007 in people with Neuralgia, run by Eisai Inc. at 1 site in United States.

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 6 inclusion and 3 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 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?

Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. (time frame: Baseline and Week 48). The study lists 3 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 NCT00592904.

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 21 Jan 2016.