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

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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592904

Enrollment

262

Registered

2008-01-14

Start date

2008-01-31

Completion date

2011-07-31

Last updated

2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia

Keywords

Neuralgia, neuropathy

Brief 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).

Interventions

DRUGE2007

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Each patient must meet all of the following criteria to be enrolled in this study: 1. 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. 2. 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. 3. 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. 4. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures. 5. Is reliable, willing, and able to cooperate with the study procedures.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)	Baseline and Week 48	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). \[Please note high withdrawl rate during study\].
Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT	Baseline and Week 48	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.	57
PDN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.	148
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.	27
PHN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.	30
Total	262

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	15	25	13	5
Overall Study	Lack of Efficacy	2	7	2	3
Overall Study	Other	3	3	0	0
Overall Study	Physician Decision	0	3	1	0
Overall Study	Protocol Violation	1	1	0	1
Overall Study	Withdrawal by Subject	4	16	1	2

Baseline characteristics

Characteristic	Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo	PDN: Prior Treatment of Perampanel	Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo	PHN: Prior Treatment of Perampanel	Total
Age, Customized <65	40 Participants	97 Participants	9 Participants	9 Participants	155 Participants
Age, Customized ≥65	17 Participants	51 Participants	18 Participants	21 Participants	107 Participants
Race/Ethnicity, Customized Asian	2 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Race/Ethnicity, Customized Black	4 Participants	11 Participants	0 Participants	3 Participants	18 Participants
Race/Ethnicity, Customized Other	3 Participants	9 Participants	1 Participants	3 Participants	16 Participants
Race/Ethnicity, Customized White	48 Participants	127 Participants	26 Participants	24 Participants	225 Participants
Sex: Female, Male Female	28 Participants	52 Participants	11 Participants	22 Participants	113 Participants
Sex: Female, Male Male	29 Participants	96 Participants	16 Participants	8 Participants	149 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	72 / 84	132 / 178	160 / 205	44 / 57
serious Total, serious adverse events	11 / 84	25 / 178	31 / 205	5 / 57

Outcome results

Primary

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).