An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy

NCT00505284 | Completed Phase 2 Results

• 2 other identifiers: E2007-G000-2272006-006488-22
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy and safety of Perampanel in patients with painful diabetic neuropathy.

Conditions

Diabetic Neuropathy

Keywords

Diabetic neuropathy

Outcome Measures

Primary Outcomes (4)

• Change in Average Pain Scores From Baseline to Week 15/End of Treatment (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).

  Baseline to Week 15/EOT

• 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

  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.

  Baseline to Week 15/EOT

• 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

  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.

  Baseline to Week 15/EOT

• Mean Change in Average Pain Scores From Baseline at Each Study Week

  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.

  Baseline, Week 1 to Week 17

Secondary Outcomes (8)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Perampanel 2mg

ACTIVE COMPARATOR

Drug: E2007 (2 mg)

Perampanel 4mg

ACTIVE COMPARATOR

Drug: E2007 (4 mg)

Perampanel 6mg

ACTIVE COMPARATOR

Drug: E2007 (6 mg)

Perampanel 8mg

ACTIVE COMPARATOR

Drug: E2007 (8 mg)

Interventions

Placebo DRUG

Placebo tablets, once daily, for 15 weeks (taken orally).

Placebo

E2007 (2 mg) DRUG

Perampanel, 2 mg once daily, for 15 weeks (taken orally).

Also known as: Perampanel

Perampanel 2mg

E2007 (4 mg) DRUG

Perampanel, 2 mg once daily for three weeks, followed by 4 mg, once daily, for 12 weeks (taken orally).

Also known as: Perampanel

Perampanel 4mg

E2007 (6 mg) DRUG

Perampanel, 2 mg once daily for three weeks, followed by 4 mg once daily, for three weeks and 6 mg, once daily, for nine weeks (taken orally).

Also known as: Perampanel

Perampanel 6mg

E2007 (8 mg) DRUG

Perampanel, 2 mg once daily, for three weeks, followed by 4 mg, once daily for three weeks, 6 mg once daily for three weeks and 8 mg, once daily, for six weeks (taken orally).

Also known as: Perampanel

Perampanel 8mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included, patients must meet all of the following:
• Provide written informed consent, prior to entering the study or undergoing any study procedures
• Male and female patients ≥18 years of age will be eligible for enrollment. Females should be either not of childbearing 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 Screening (Visit 1) and for 1 month after the end of the study (Visit 8). They must also have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening (Visit 1). Those females using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) starting with the Baseline Phase and continuing throughout the study period.
• Have Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 12 months duration
• Have pain that has been stable over the past 6 months and, in the opinion of the investigator, not in an identifiably improving or worsening trend
• Have hemoglobin A1c ≤ 11%
• Score of ≥ 40 mm on the visual analog scale (VAS) of the short form McGill Pain Questionnaire (SF-MPQ) at both Screening (Visit 1) and Baseline (Visit 2 prior to randomization)
• Have completed the patient diary for at least 6 of the 7 days prior to Baseline (Visit 2)
• Have average daily pain score of ≥ 4, on 11-point Likert-type numeric rating scale during the 7 days prior to Baseline (to be obtained from the patient diary)
• Be reliable, willing, and able to cooperate with all study procedures including the following:
• accurately fill out the diary on a daily basis
• return for study visits on the required dates
• accurately and reliably report symptoms (including treatment-emergent signs and symptoms)
• take study drug as required by protocol
• Be on stable antidiabetic treatment (insulin, oral agents, or lifestyle) that is not anticipated to change during the course of the study, except if medically required

You may not qualify if:

• Patients with any one of the following will be excluded.
• Patients with any condition that could interfere with the conduct of the study or confound efficacy evaluations including the following:
• Pain or neuropathy from another cause (including central pain, radiculopathy, painful arthritis, etc.)
• Skin or soft-tissue lesions in the area affected by neuropathy that are painful or could alter sensation
• Amputation, other than toes
• Patients motivated by secondary gain, or where there is a negative-incentive to achieving pain and functional pain relief (eg, litigation). This will be determined by the patient's medical history.
• Patients with clinically significant, progressive, or potentially unstable disease of any body system including cardiovascular, gastrointestinal, CNS, psychiatric, endocrine (other than diabetes), or immunologic, including patients with any of the following broad disease categories:
• Systemic infections (e.g., human immunodeficiency virus \[HIV\], hepatitis, tuberculosis \[TB\], syphilis)
• 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
• 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
• Patients with any of the following laboratory abnormalities at Screening (Visit 1) or Baseline (Visit 2):
• Clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc (defined as QTc ≥ 450 msec)

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Limited: collaborator

Study Sites (1)

Dr. Richard Blonsky

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

perampanel

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Antonio Laurenza, M.D.

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 23, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 11, 2014
• Results First Posted: February 8, 2013

Record last verified: 2013-02

Locations

US (1)