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Medication Overuse HeadachePhase 2NCT01044251

Frovatriptan as a Transitional Therapy in Medication Overuse Headache

A Phase 2 study testing Frovatriptan in people with Medication Overuse Headache and Analgesic Overuse Headache, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Frovatriptan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteCanada
Study dates
Jan 2010to 17 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • South Health Campus

    Calgary, Alberta, T3M 1M4

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Frovatriptan, Placebo
Keywords
Medication overuse headache, Rebound headache, Analgesic overuse headache, Transitional therapy, Frovatriptan, Migraine
Medical subject headings
Headache Disorders, Secondary, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FrovatriptanDrug

    2.5 mg po bid for 10 days

  • PlaceboDrug

    1 tab po bid for 10 days

Study groups in NCT01044251
Study groupRoleWhat they receive
PlaceboPlacebo comparator10 days of treatment with placebo in a bid fashion that will look like the study medication.
Receives: Drug: Placebo
FrovatriptanExperimentalFrovatriptan 2.5 mg po bid for 10 days
Receives: Drug: Frovatriptan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: After 10 days of therapy

Secondary outcomes (4)

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

    Measured: After 10 days of therapy

  2. 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.

    Measured: After 10 days and after 20 days

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

    Measured: After 2 months

  4. 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).

    Measured: After 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completion17 Apr 2019
  4. Study completion17 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01044251
Sponsor's protocol ID
22522
Status last verified
Apr 2019
First submitted
5 Jan 2010
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18483706

  • 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.

    PubMed 18823363

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

    PubMed 18728819

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

    PubMed 18001261

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Frovatriptan in people with Medication Overuse Headache and Analgesic Overuse Headache, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01044251, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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