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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

duloxetine

About this trial

This is an interventional prevention trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Jefferson Headache Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

Duloxetine 120mg daily for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Secondary Outcome Measures

Full Information

NCT ID

NCT00443352

First Posted

March 5, 2007

Last Updated

April 25, 2014

Sponsor

Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT00443352

Brief Title

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

Official Title

A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Experimental

Arm Description

Duloxetine 120mg daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Primary Outcome Measure Information:

Title

Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.

Description

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Time Frame

Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William B. Young, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jefferson Headache Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

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

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