An Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01146509
First received: April 28, 2009
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of this extension study was to evaluate the safety and efficacy of donepezil hydrochloride after extended use in migraine prophylaxis. Efficacy will continue to be evaluated.


Condition Intervention Phase
Migraine Headache
Drug: Aricept (donepezil hydrochloride)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, One-Year Extension Of The Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety: physical examination, vital signs measurement, clinical laboratory evaluation, 12-lead ECG measurement, adverse event (AE) evaluation. [ Time Frame: Every visit up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients experiencing ≥ 50% reduction in migraine frequency per month ("responders"). [ Time Frame: Weeks 4, 16, 28, 40 and 52. ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: January 2003
Study Completion Date: March 2007
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Aricept (donepezil hydrochloride)
Donepezil hydrochloride tablet: initial 5 mg/day dose was taken orally, once a day. At Week 4 visit, the dose was increased to 10 mg/day at the discretion of the investigator.
Other Name: donepezil hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have completed study E2020-A001-211 according to the protocol.
  2. Male and female patients between 18-65 years of age. Women of childbearing potential practiced effective contraception (e.g., abstinence, intra-uterine device (IUD) or barrier method plus hormonal method), had a negative urine -hCG at Week 0, and be willing to remain on their current form of contraception for the duration of the study. Pregnant and/or lactating females were to be excluded.
  3. Patients of any race who were in generally good health.
  4. Patient was willing to participate, and has provided written informed consent prior to being exposed to any study-related procedures.

Exclusion Criteria:

  1. Evidence of any clinically significant disorder which was being evaluated medically, and which had not been shown to be stable on medications or other treatment(s) for a period of at least 3 months, including active or uncontrolled tumors, non-trauma related cerebrovascular accidents, gastrointestinal, renal, hepatic, endocrine or pulmonary disease, cardiovascular system disease or known collagen vascular disease (e.g., systemic lupus erythematosus). Hypertension was medication controlled (supine diastolic BP < 95 mmHg). Cardiac disease (angina pectoris, congestive heart failure or arrhythmias) was stable on appropriate medication for 6 months. No elective surgical procedures were allowed during the course of the study.
  2. Patients with a recent history (</= 2 years) of or on active treatment for any hematologic/oncologic disorders (other than basal or squamous cell carcinoma of the skin).
  3. Patients with a serious central nervous system (CNS) disorder (e.g., neoplasm, infection, demyelinating disease, degenerative neurological disease such as Alzheimer's disease, Parkinson's disease, vascular dementia, or any other progressive CNS disease) or who either evidence focal neurological signs or symptoms by examination or history (e.g., papilledema) or who evidence transient neurological symptoms without an ensuing headache.
  4. Any medical or psychiatric (e.g., severe depression, psychosis, bipolar disorder) condition which, in the opinion of the Investigator, made the patient unsuitable for the study.
  5. History of chronic alcoholism or drug abuse as defined by DSM-IV criteria or patients who had previously been hospitalized and/or treated for substance abuse within the past one year.
  6. History of overuse (> 12 days per four week period on average) of acute headache medications including analgesics, opioids, Non-steroidal anti-inflammatory drugs (NSAIDs), butalbital containing compounds, ergots and triptans within the past one (1) year.
  7. Patients who were taking any prior or concomitant medications, as defined in the Protocol (Appendix 16.1.1), during the study.
  8. Patients who were unwilling or unable to fulfill the requirements of the study.
  9. Patients with known hypersensitivity to piperidine derivatives.
  10. Patients who had taken a cholinesterase inhibitor (e.g., donepezil, tacrine, rivastigmine, galantamine, metrifonate) for the acute or prophylactic treatment of migraines in the past (excluding E2020-A001-211) or who were currently taking a cholinesterase inhibitor for any other indication.
  11. Patients who had taken any unapproved prior or concomitant medications. In particular, patients were not allowed to take beta-blockers, tricyclic antidepressants, calcium channel blockers, monoamine oxidase inhibitors, valproate, methysergide, cyproheptadine or any other ongoing prophylactic treatment for migraines while participating in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146509

Locations
United States, Illinois
Diamond Headache Clinical
Chicago, Illinois, United States, 60614
United States, Missouri
Clinvest/Headache Care Center
Springfield, Missouri, United States, 65804
United States, New York
Elkind Headache Center
Mount Vernon, New York, United States, 10550
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Margaret Moline Eisai Inc.
  More Information

No publications provided

Responsible Party: Margaret Moline, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT01146509     History of Changes
Other Study ID Numbers: E2020-A001-213
Study First Received: April 28, 2009
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
migraine
headache

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014