NCT01044251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

9.3 years

First QC Date

January 5, 2010

Last Update Submit

April 17, 2019

Conditions

Medication Overuse HeadacheAnalgesic Overuse Headache

Keywords

Medication overuse headacheRebound headacheAnalgesic overuse headacheTransitional therapyFrovatriptanMigraine

Outcome Measures

Primary Outcomes (1)

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

    After 10 days of therapy

Secondary Outcomes (4)

  • The difference in mean headache intensity between the 10 day transitional period and the baseline period.

    After 10 days of therapy

  • 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.

    After 10 days and after 20 days

  • Number of headache-free days (grade zero) for first two months of study.

    After 2 months

  • 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).

    After 2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Frovatriptan

EXPERIMENTAL

Frovatriptan 2.5 mg po bid for 10 days

Drug: Frovatriptan

Interventions

FrovatriptanDRUG

2.5 mg po bid for 10 days

Frovatriptan
PlaceboDRUG

1 tab po bid for 10 days

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 18483706BACKGROUND

  • 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.

    PMID: 18823363BACKGROUND

  • Kelman L. Review of frovatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2008 Feb;4(1):49-54. doi: 10.2147/ndt.s1871.

    PMID: 18728819BACKGROUND

  • Markus F, Mikko K. Frovatriptan review. Expert Opin Pharmacother. 2007 Dec;8(17):3029-33. doi: 10.1517/14656566.8.17.3029.

    PMID: 18001261BACKGROUND

MeSH Terms

Conditions

Headache Disorders, SecondaryMigraine Disorders

Interventions

frovatriptan

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, Primary

Study Officials

  • Werner J Becker, MD, FRCPC

    University of Calgary

    STUDY DIRECTOR

  • Farnaz Amoozegar, MD, FRCPC

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 7, 2010

Study Start

January 1, 2010

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

CA(1)