A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group study. This is a 5-arm, 21-week study comprised of up to a 2-week Screening period, a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 (2 mg, 4 mg, 6 mg, and 8 mg) or placebo, and a 4-week, single-blind placebo Follow-Up Phase. Patients will be randomly assigned to one of the five treatment groups. Those patients assigned to receive either 4 mg, 6 mg, or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule. All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Intervention: Placebo (Drug)
Perampanel 2mg
Intervention: E2007 (2 mg) (Drug)
Perampanel 4mg
Intervention: E2007 (4 mg) (Drug)
Perampanel 6mg
Intervention: E2007 (6 mg) (Drug)
Perampanel 8mg
Intervention: E2007 (8 mg) (Drug)
Outcomes
Primary Outcomes
Change in Average Pain Scores From Baseline to Week 15/End of Treatment (EOT)
Time Frame: Baseline to Week 15/EOT
Average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified baseline observation carried forward (BOCF).
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 30% Reduction in Pain Score
Time Frame: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Responder Rate: Analysis of the Change in Pain Score From Baseline to Week 15/EOT in Subjects Who Had at Least a 50% Reduction in Pain Score
Time Frame: Baseline to Week 15/EOT
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). This is based on a modified BOCF.
Mean Change in Average Pain Scores From Baseline at Each Study Week
Time Frame: Baseline, Week 1 to Week 17
Average pain scores were calculated as the average of last 7 available scores prior to the visit, based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Last on-treatment value refers to last 7 days of available diary data while subject was on double-blind study drug.
Secondary Outcomes
- Change in Average Sleep Interference Scores From Baseline to Week 15/EOT(Baseline to Week 15/EOT)
- Change in Short Form - McGill Pain Questionnaire (SF-MPQ) From Baseline to Week 15/EOT(Baseline and Week 15/EOT)
- Analysis of Patient Global Impression of Change (PGIC) at Week 15/EOT(Week 15/EOT)
- Change From Baseline to Week 15/EOT in SF-36 Physical and Mental Component Scores(Baseline and Week 15/EOT)
- Change From Baseline to Week 15/EOT in Hospital Anxiety and Depression Scale (HADS) Anxiety and Depression Subscale Scores(Baseline and Week 15/EOT)
- Withdrawal Due to Treatment Failure During Double-Blind Dosing Period(Baseline and Week 15)
- Presence or Absence of Allodynia at Week 15/EOT(Week 15/EOT)
- Analysis of Rescue Analgesic Medication Use (Acetaminophen) During Double-Blind Dosing Period(Baseline to Week 15)