Migraine HeadachePhase 2NCT01146509
An Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis
A Phase 2 study testing Aricept (donepezil hydrochloride) in people with Migraine Headache, run by Eisai Inc. at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Aricept (donepezil hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2003to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have completed study E2020-A001-211 according to the protocol.
- 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.
- Patients of any race who were in generally good health.
- Patient was willing to participate, and has provided written informed consent prior to being exposed to any study-related procedures.
Who cannot join
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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- Patients who were taking any prior or concomitant medications, as defined in the Protocol (Appendix 16.1.1), during the study.
- Patients who were unwilling or unable to fulfill the requirements of the study.
- Patients with known hypersensitivity to piperidine derivatives.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Diamond Headache Clinical
Chicago, Illinois, 60614
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Elkind Headache Center
Mount Vernon, New York, 10550
Clinvest/Headache Care Center
Springfield, Missouri, 65804
About this study
Official title: An Open-Label, Multicenter, One-Year Extension Of The Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis
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.
- Conditions
- Migraine Headache
- Being tested
- Aricept (donepezil hydrochloride)
- Keywords
- migraine, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aricept (donepezil hydrochloride)Drug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Aricept (donepezil hydrochloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: physical examination, vital signs measurement, clinical laboratory evaluation, 12-lead ECG measurement, adverse event (AE) evaluation.
Measured: Every visit up to 52 weeks
Secondary outcomes (1)
Proportion of patients experiencing ≥ 50% reduction in migraine frequency per month ("responders").
Measured: Weeks 4, 16, 28, 40 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJan 2003
- Primary completionApr 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margaret Moline, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146509
- Sponsor's protocol ID
- E2020-A001-213
- Status last verified
- Dec 2012
- First submitted
- 28 Apr 2009
- Last updated
- 10 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, One-Year Extension Of The Evaluation Of The Efficacy And Safety Of Donepezil Hydrochloride (E2020) In Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT01146509
- Acronym / sponsor ID
- E2020-A001-213
- Conditions
- Migraine Headache
- Keywords
- migraine, headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aricept (donepezil hydrochloride) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must have completed study E2020-A001-211 according to the protocol.
- 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.
- Patients of any race who were in generally good health.
- Patient was willing to participate, and has provided written informed consent prior to being exposed to any study-related procedures.
Key exclusion criteria (11 listed)
- 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.
- 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).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aricept (donepezil hydrochloride)Also: donepezil hydrochlorideDonepezil 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. | Drug | 1 |
Primary outcome
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
1 secondary outcome
Proportion of patients experiencing ≥ 50% reduction in migraine frequency per month ("responders").
Time frame: Weeks 4, 16, 28, 40 and 52.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Moline study director
Eisai Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aricept (donepezil hydrochloride) in people with Migraine Headache, run by Eisai Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2012.