A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

Thomas Jefferson University

Status and phase

Completed

Phase 4

Conditions

Migraine

Treatments

Drug: duloxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00443352

Protocol #: F1J-MC-I

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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