A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
Information source: Thomas Jefferson University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: duloxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Thomas Jefferson University Official(s) and/or principal investigator(s): William B. Young, MD, Principal Investigator, Affiliation: Thomas Jefferson University
Summary
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety
and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic
migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered
into an 84-day treatment period. Subjects will be titrated over the first four weeks to a
dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on
individual subject response and/or subject's tolerability. Subjects will maintain a daily
diary capturing detailed information on migraine headache days.
Clinical Details
Official title: A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.
Detailed description:
Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment
and prophylactic treatment. Acute headache medication is intended to relieve the pain and
disability of an acute attack and stop its progression. Prophylactic (preventive) headache
therapy is generally given daily, even in the absence of headache, to reduce the frequency
and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine
attacks which significantly interfere with the subject's daily routine despite acute
treatment, may warrant chronic prophylactic treatment.
Duloxetine may be an important treatment option for millions of unsuccessfully treated
migraine patients and therefore warrants further study. Considering this, we propose a
single-center, open-label pilot trial to collect and evaluate data on the safety and
efficacy of duloxetine in the preventive treatment of subjects with episodic migraine
headaches. The results of this pilot trial will provide preliminary insight into the
clinical role duloxetine may play in the treatment of headache, as well as provide a basis
for future well-controlled trials of this medication.
This is a single-center, open-label, pilot trial to collect and evaluate data on the safety
and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic
migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered
into an 84-day treatment period. Subjects will be titrated over the first four weeks to a
dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on
individual subject response and/or subject's tolerability. Subjects will maintain a daily
diary capturing detailed information on migraine headache days.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is male or female between the ages of 18 and 65, inclusive
- Subject has an IHS diagnosis of migraine with or without aura for at least one-year
prior to screening
- Subject has experienced between 4 and 10 migraine headaches per month (inclusive)
over the past six months, with at least 24 hours separating attacks
- Subject has less than 15 total headache days per month
- Subject is able to differentiate migraine attacks from other headache types, if
applicable
- Subjects daily medications (for any indication) have remained at a stable dose for
the 60 days preceding screening
- Subject is using or agrees to use for the duration of participation a medically
acceptable form of contraception (as determined by investigator and mutually agreed
upon with patient), if female of child-bearing potential
- Subjects currently taking a single agent for the prevention of migraine must be on a
stable dose (unchanged for 2 months) prior to study entry
- Subject has negative urine pregnancy test prior to study entry, if female of
child-bearing potential
- Subject is able to understand and comply with all study requirements
- Subject provides written informed consent prior to any screening procedures being
conducted
EXCLUSION CRITERIA:
- Subjects with onset of migraine after 50 years of age
- Subjects who have been previously treated or are currently being treated with
duloxetine
- Subjects who have failed greater than 3 adequate trials of other medications the
prevention of migraine, as determined by investigator
- Subjects who have a known hypersensitivity to duloxetine or any of the inactive
ingredients
- Subject has taken any medication which has been shown to be effective for migraine
prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time
during participation in the study, for any indication.
- Subjects with a history of significant drug or alcohol abuse within the past year
- Subjects with major depressive disorder or who have had a suicidal ideation in the 3
months prior to screening or have a history of attempted suicide
- Subjects who have a Beck Depression Inventory score of > 18 at screening
- Subjects who have > 0 on question number 9 of Beck Depression Inventory (Suicidal
Thoughts or Wishes question)
- Subjects who have participated in an investigational drug trial in the 30 days prior
to the screening visit
- Subjects with a current or history of a hepatic or renal disorder
- Subjects with uncontrolled narrow angle glaucoma
- Subjects who have experienced significant side effects from two different SSRI and/or
SNRI therapies, as determined by investigator
- Subjects with uncontrolled restless legs syndrome, as determined by investigator
Locations and Contacts
Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States
Additional Information
Starting date: August 2007
Last updated: April 25, 2014
|