Frovatriptan as a Transitional Therapy in Medication Overuse Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Calgary
Sponsor:
Collaborator:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Farnaz Amoozegar, University of Calgary
ClinicalTrials.gov Identifier:
NCT01044251
First received: January 5, 2010
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Medication Overuse Headache
Analgesic Overuse Headache
Drug: Frovatriptan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Frovatriptan as a Transitional Therapy in Medication Overuse Headache

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in mean headache intensity between the 10 day transitional period and the baseline period. [ Time Frame: After 10 days of therapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of headache-free days (grade zero) for first two months of study. [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: January 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
10 days of treatment with placebo in a bid fashion that will look like the study medication.
Drug: Placebo
1 tab po bid for 10 days
Experimental: Frovatriptan
Frovatriptan 2.5 mg po bid for 10 days
Drug: Frovatriptan
2.5 mg po bid for 10 days
Other Name: Frova

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044251

Contacts
Contact: Farnaz Amoozegar, MD, FRCPC 403-944-4247 farnaz.amoozegar@albertahealthservices.ca
Contact: Werner Becker, MD, FRCPC 403-944-4240 wbecker@ucalgary.ca

Locations
Canada, Alberta
Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Farnaz Amoozegar, MD, FRCPC    403-944-4247    farnaz.amoozegar@albertahealthservices.ca   
Sub-Investigator: Farnaz Amoozegar, MD, FRCPC         
Principal Investigator: Werner J Becker, MD, FRCPC         
Sponsors and Collaborators
University of Calgary
AHS Cancer Control Alberta
Investigators
Principal Investigator: Werner J Becker, MD, FRCPC University of Calgary
Study Director: Farnaz Amoozegar, MD, FRCPC University of Calgary
  More Information

Publications:
Responsible Party: Farnaz Amoozegar, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01044251     History of Changes
Other Study ID Numbers: 22522
Study First Received: January 5, 2010
Last Updated: April 16, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Medication overuse headache
Rebound headache
Analgesic overuse headache
Transitional therapy
Frovatriptan
Migraine

Additional relevant MeSH terms:
Headache Disorders, Secondary
Headache Disorders
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014