Efficacy and Safety Study of E2007 in Migraine Prophylaxis

NCT00154063 | Completed Phase 2 Results

• 1 other identifier: E2007-A001-210
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 9

Brief Summary

This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.

Conditions

Migraine Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Migraine Period Frequency Per 28 Days in Treatment Phase (LOCF)

  A migraine period was defined as a migraine headache that started, ended, or recurred within 24 hours. If the headache persisted for longer than 24 hours, it was considered a new migraine period. Participants recorded the frequency of migraine period in diary. Efficacy analyses were performed using both the 24-hour and 48-hour rule for defining migraine periods. Data is presented as mean number of migraine period per 28 days +/- standard error. A negative change indicates a decrease in the number of migraine periods from baseline. LOCF = last observation carried forward (ie, observation from last phase with active treatment)

  Baseline to Week 19

Secondary Outcomes (16)

• Change From Baseline in Average Duration Per Migraine Attack in Treatment Phase (LOCF)

  Baseline to Week 19

• Change From Baseline in Average Migraine Severity Per Migraine Attack in Treatment Phase (LOCF)

  Baseline to Week 19

• Change From Baseline in Migraine Attack Frequency Per 28 Days in Treatment Phase (LOCF)

  Baseline to Week 19

• Change From Baseline in Migraine Period Frequency Per 28 Days in Maintenance Phase

  Baseline, Week 11 to Week 19

• Change From Baseline in Number of Days Requiring Symptomatic Rescue Medication Per 28 Days in Treatment Phase (LOCF)

  Baseline to Week 19

Study Arms (2)

Placebo

PLACEBO COMPARATOR

During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).

Other: Placebo

E2007

EXPERIMENTAL

During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).

Drug: E2007

Interventions

E2007 DRUG

E2007

Placebo OTHER

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients of any race, 18 to 65 years of age inclusive.
• Patients with a history of migraine (with or without aura) according to the Headache Classification Committee of the IHS. Migraine attacks have to have had an onset before age 50 and have to have been present for at least 12 months.
• Patients with 4-12 qualified migraine attacks per month over the past three months prior to Screening, as well as during the four weeks of the Baseline Phase will be eligible for entry into this study. The interval between two qualified migraine attacks should be at least 24 hours to be counted as distinct migraine attacks. A qualified migraine attack without aura is defined as a headache that lasts 4-72 hours (if untreated or unsuccessfully treated) or if successfully treated (revised per Amendment 01). This attack has at least two of the following characteristics: unilateral location, pulsating quality, moderate or severe intensity that inhibits or prohibits daily activities or aggravation by routine physical activities such as walking up stairs. In addition, at least one of the following symptoms must be present during the headache: nausea, vomiting, or photophobia and phonophobia (revised per Amendments 01 and 02). A qualified migraine attack with aura must fulfill the same criteria as the headache attack, plus have an associated aura as defined by the Migraine Criteria of the Headache Classification Committee of the International Headache Society. An aura alone that requires acute migraine treatment will also be considered a migraine attack.
• Male and female patients will be eligible for enrollment. Females should be either of non-childbearing potential by reason of surgery, radiation, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or IUD) for at least one month before study randomization and for two months after the end of the study, and have a negative serum B-hCG at Screening. Pregnant and/or lactating females are excluded. Those women using hormonal contraceptives must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.
• Patients with a Body Mass Index (BMI) between 19 to 40 kg/m2 inclusive at Screening.
• Patients who are willing to participate and have provided written informed consent prior to being exposed to any study-related procedures.

You may not qualify if:

• Patients with chronic daily headaches as defined by more than 14 headache days per month on average during the three months prior to Screening,
• Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the IHS 2004),
• Patients with a history of being non-responsive to more than two classes of adequately conducted, prophylactic migraine treatments (e.g., beta blockers, calcium channel blockers, tricyclics, MAOIs, valproate (divalproex), topiramate, gabapentin),
• Patients who use the following medications as described:
• Use of marketed triptans for 10 days or greater per month on average,
• Use of ergot-containing medications for ten days or greater per month on average,
• Use of NSAIDs, acetaminophen, or isometheptene-containing agents for 15 days or greater per month on average,
• Use of opioids for 10 days or greater per month on average,
• Use of any two or more of the above medications for 15 days or greater per month on average,
• Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting,
• Patients with a history of or currently having major psychiatric disorders including schizophrenia, major depressive disorder, or bipolar disorder,
• Patients who are known to be positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV),
• Patients with elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \>= 1.5 times the upper limit of normal (ULN),
• Patients with evidence of significant active hematological disease; white blood cell count cannot be less than or equal to 2500/uL or an absolute neutrophil count less than or equal to 1000/uL,
• Patients with clinically significant ECG abnormality, including prolonged QTc (Fridericia correction) defined as \>= 450 msec for males and \>= 470 msec for females,

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (9)

Investigational Site

Oceanside, California, 92056, United States

Location

Investigational Site

Santa Monica, California, 90404, United States

Location

Investigational Site

Tampa, Florida, 33606, United States

Location

Investigational Site

West Palm Beach, Florida, 33407, United States

Location

Investigational Site

Chicago, Illinois, 60614, United States

Location

Investigational Site

Springfield, Missouri, 65807, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10550, United States

Location

Investigational Site

Greensboro, North Carolina, 27401, United States

Location

Investigational Site

Houston, Texas, 77004, United States

Location

MeSH Terms

Interventions

perampanel

Results Point of Contact

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

888-422-4743

Study Officials

• Julia Young, M.D., Ph.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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2009-08

Locations

US (9)