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Frovatriptan as a Transitional Therapy in Medication Overuse Headache

Primary Purpose

Medication Overuse Headache, Analgesic Overuse Headache

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Frovatriptan
Placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medication Overuse Headache focused on measuring Medication overuse headache, Rebound headache, Analgesic overuse headache, Transitional therapy, Frovatriptan, Migraine

Eligibility Criteria

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

Inclusion Criteria:

  • MOH diagnosed by IHS criteria
  • Diagnosis of migraine (with or without aura) in past by IHS criteria
  • If patients do not have a baseline diary, then a prospective diary for a 10-day period will be done to confirm medication overuse before study entry.
  • Patients aged 18 to 65 years.
  • Normal neurological examination.
  • Patient is willing and able (in terms of capacity) to sign informed consent.
  • Patient is able to understand and complete study protocol, including completion of headache diaries.
  • Patient has a stable medical condition.

Exclusion Criteria:

  • Headache not meeting IHS criteria for MOH.
  • Presence of hemiplegic, basilar, ophthalmoplegic migraine or migrainous infarction.
  • Findings on history, neurological exam, or neuroimaging suggestive of secondary causes of headache.
  • Post-whiplash or post-traumatic headaches.
  • Contraindications to triptans (such as heart disease, peripheral vascular disease or uncontrolled hypertension) or previous serious side effects/intolerance.
  • Major psychiatric conditions (such as major depression, bipolar disorder, schizophrenia, addiction), either diagnosed by a physician or positive on standard clinic assessment tools (e.g. BDI questionnaire).
  • Major medical conditions or treatments that may interfere with the patient's ability to participate in the study, such as dementia, advanced or terminal cancer, chemotherapy, etc.
  • Patient is pregnant, breastfeeding, or is expecting to conceive within the time period of the study. Pregnancy will be determined using a urine test.
  • Women of childbearing potential who are not using a reliable method of contraception.
  • Patient is a recent user of illicit/recreational drugs or plans to use illicit drugs during the study time period.
  • Patient has a recent history of alcohol abuse or dependence, or plans to abuse alcohol during the study duration.
  • Patient is unlikely to comply with the study protocol, keep diaries and appointments, or does not have a fixed telephone or address.
  • Patient is enrolled in another study or trial that may interfere with their participation or the results of this study.
  • Patients with greater than 30% of their data missing during the ten days of baseline diary data collection.
  • Patients with mean headache intensities of less than 3 (from a pain scale of 0 to 10, where 0=no pain and 10=pain as bad as possible) during the 10-day baseline period.
  • Patients with ongoing Botox treatments or those who have received Botox in the last 4 months.

Sites / Locations

  • South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Frovatriptan

Arm Description

10 days of treatment with placebo in a bid fashion that will look like the study medication.

Frovatriptan 2.5 mg po bid for 10 days

Outcomes

Primary Outcome Measures

The mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group.

Secondary Outcome Measures

The difference in mean headache intensity between the 10 day transitional period and the baseline period.
The number of day segments with headache of grade 6 or higher during the 10 day transitional period and during days 11-20 of the study.
Number of headache-free days (grade zero) for first two months of study.
Proportion of patients free of medication overuse for first two months of study (i.e. less than 15 days of simple analgesic use or less than 10 days of other analgesic use per month).

Full Information

First Posted
January 5, 2010
Last Updated
April 17, 2019
Sponsor
University of Calgary
Collaborators
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT01044251
Brief Title
Frovatriptan as a Transitional Therapy in Medication Overuse Headache
Official Title
Frovatriptan as a Transitional Therapy in Medication Overuse Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Alberta Health services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will analyze the effectiveness of a medication called Frovatriptan, in the context of medication overuse headache (MOH). MOH is a headache that develops when pain-killers are taken frequently. The treatment is to stop the overuse of these pain-killers, but that can sometimes worsen the headache first before it gets better. We are testing Frovatriptan against placebo to see if it can help patients with this transition and avoid the worsening of the headache that can occur. We will also see if Frovatriptan can help in other ways, such as maintain patients free of medication overuse.
Detailed Description
A single-centre, randomized, placebo-controlled trial is proposed to assess Frovatriptan as a transitional therapy in patients diagnosed with medication overuse headache. Currently, there are no proven transitional therapies to help patients get through the detoxification process. Frovatriptan has not been tested as a transitional therapy in the past. This study will compare Frovatriptan, taken over a 10 day transitional period, to placebo. The primary outcome of the study will be the mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group. A number of secondary and exploratory outcomes will also be determined and further data collection will occur at 1, 2, and 3 month periods. The duration of the study for the participants will be 3 months, and they will be asked to keep detailed headache diaries during this time. Ten days of baseline headache diaries will also be performed before patients can enter the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache, Analgesic Overuse Headache
Keywords
Medication overuse headache, Rebound headache, Analgesic overuse headache, Transitional therapy, Frovatriptan, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 days of treatment with placebo in a bid fashion that will look like the study medication.
Arm Title
Frovatriptan
Arm Type
Experimental
Arm Description
Frovatriptan 2.5 mg po bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Frovatriptan
Intervention Description
2.5 mg po bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tab po bid for 10 days
Primary Outcome Measure Information:
Title
The mean headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group.
Time Frame
After 10 days of therapy
Secondary Outcome Measure Information:
Title
The difference in mean headache intensity between the 10 day transitional period and the baseline period.
Time Frame
After 10 days of therapy
Title
The number of day segments with headache of grade 6 or higher during the 10 day transitional period and during days 11-20 of the study.
Time Frame
After 10 days and after 20 days
Title
Number of headache-free days (grade zero) for first two months of study.
Time Frame
After 2 months
Title
Proportion of patients free of medication overuse for first two months of study (i.e. less than 15 days of simple analgesic use or less than 10 days of other analgesic use per month).
Time Frame
After 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MOH diagnosed by IHS criteria Diagnosis of migraine (with or without aura) in past by IHS criteria If patients do not have a baseline diary, then a prospective diary for a 10-day period will be done to confirm medication overuse before study entry. Patients aged 18 to 65 years. Normal neurological examination. Patient is willing and able (in terms of capacity) to sign informed consent. Patient is able to understand and complete study protocol, including completion of headache diaries. Patient has a stable medical condition. Exclusion Criteria: Headache not meeting IHS criteria for MOH. Presence of hemiplegic, basilar, ophthalmoplegic migraine or migrainous infarction. Findings on history, neurological exam, or neuroimaging suggestive of secondary causes of headache. Post-whiplash or post-traumatic headaches. Contraindications to triptans (such as heart disease, peripheral vascular disease or uncontrolled hypertension) or previous serious side effects/intolerance. Major psychiatric conditions (such as major depression, bipolar disorder, schizophrenia, addiction), either diagnosed by a physician or positive on standard clinic assessment tools (e.g. BDI questionnaire). Major medical conditions or treatments that may interfere with the patient's ability to participate in the study, such as dementia, advanced or terminal cancer, chemotherapy, etc. Patient is pregnant, breastfeeding, or is expecting to conceive within the time period of the study. Pregnancy will be determined using a urine test. Women of childbearing potential who are not using a reliable method of contraception. Patient is a recent user of illicit/recreational drugs or plans to use illicit drugs during the study time period. Patient has a recent history of alcohol abuse or dependence, or plans to abuse alcohol during the study duration. Patient is unlikely to comply with the study protocol, keep diaries and appointments, or does not have a fixed telephone or address. Patient is enrolled in another study or trial that may interfere with their participation or the results of this study. Patients with greater than 30% of their data missing during the ten days of baseline diary data collection. Patients with mean headache intensities of less than 3 (from a pain scale of 0 to 10, where 0=no pain and 10=pain as bad as possible) during the 10-day baseline period. Patients with ongoing Botox treatments or those who have received Botox in the last 4 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner J Becker, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Farnaz Amoozegar, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18483706
Citation
Grazzi L, Andrasik F, Usai S, Bussone G. Headache with medication overuse: treatment strategies and proposals of relapse prevention. Neurol Sci. 2008 Apr;29(2):93-8. doi: 10.1007/s10072-008-0867-8. Epub 2008 May 16.
Results Reference
background
PubMed Identifier
18823363
Citation
Hagen K, Albretsen C, Vilming ST, Salvesen R, Gronning M, Helde G, Gravdahl G, Zwart JA, Stovner LJ. Management of medication overuse headache: 1-year randomized multicentre open-label trial. Cephalalgia. 2009 Feb;29(2):221-32. doi: 10.1111/j.1468-2982.2008.01711.x. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
18728819
Citation
Kelman L. Review of frovatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2008 Feb;4(1):49-54. doi: 10.2147/ndt.s1871.
Results Reference
background
PubMed Identifier
18001261
Citation
Markus F, Mikko K. Frovatriptan review. Expert Opin Pharmacother. 2007 Dec;8(17):3029-33. doi: 10.1517/14656566.8.17.3029.
Results Reference
background

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Frovatriptan as a Transitional Therapy in Medication Overuse Headache

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