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MigrainePhase 4NCT00846495

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

A Phase 4 study testing topiramate and frovatriptan in people with Migraine, run by Clinvest at 2 sites in United States.

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

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraine
What is being tested?
topiramate and frovatriptan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesUnited States
Study dates
Aug 2009to Jan 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)
  • Subject has a 3-month history of averaging 3-6 migraines per month
  • Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches
  • Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.
  • Male or female at least 18 years of age
  • Subject of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of frovatriptan and topiramate.
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  • Subject is aware of prodrome symptoms that may include physiological, psychological or cognitive changes. These may include, but are not limited to such symptoms as Pre-Menstrual Syndrome (PMS), change in mood, energy level, appetite, food craving, nausea, sense of hearing, sense of smell or swelling/fluid retention, excessive yawning, head pain, muscle pain/tenderness, irritability, confusion, extreme sleepiness, impaired speech or impaired memory. (The subject should be able to differentiate these symptoms from other similar symptoms that do not precede migraine). The symptoms should precede migraine by 4-24 hours signaling an impending migraine attack.
  • Subject is able to understand instructions for the study and complete the diary
  • Subject is willing to give informed consent to participate in the study
  • Any migraine prophylactic medication must have a stabilized dosage for one month

Who cannot join

  • History of any medical condition that would confound the results of the study including but not limited to the following:
  • Hepatic disease or significant hepatic dysfunction
  • History of pancreatitis
  • History of thrombocytopenia
  • History of glaucoma
  • History of osteoporosis or osteopenia
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  • Cardiovascular Disease - Coronary artery disease, Ischemic heart disease or Significant Arrhythmia
  • History of active Cerebrovascular Disease
  • Hypertension - Uncontrolled hypertension in a non-migrainous state (> 160 mmHg systolic or >95 mmHg. diastolic). Hypertension must be controlled effectively with medication for a period of 3 months.
  • Basilar or Hemiplegic Migraine
  • Significant peripheral vascular disease or Raynaud's Syndrome
  • Significant Active Renal, Hepatic, Gastrointestinal, Endocrine or
  • Neurological Disease
  • History of depression, mood problems or suicidal thoughts or behavior that in the opinion of the Investigator would interfere with participation in the study.
  • History of ergotamine, "triptan", or analgesic abuse within past 3 months
  • History of current or recent drug or alcohol abuse that would interfere with participation in the study.
  • More than 15 headache days per month within past 3 months.
  • Women who are pregnant or breast feeding
  • Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication
  • Subject is scheduled for surgical procedure to occur while enrolled in study.that in opinion of the Investigator would interfere with participation in the study.
  • Subject is on a ketogenic diet
  • Participation in another investigative drug study within the previous 30 days
  • Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Physician Associates LLC

    Oviedo, Florida, 32765

  • Clinvest

    Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Conditions
Migraine
Being tested
topiramate, frovatriptan
Keywords
Migraine, Migraine prevention, Prodrome, Premonitory phase, Preemptive therapy
Medical subject headings
Migraine Disorders

What participants receive

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

  • topiramateDrug

    Also called Topamax

    topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks

  • frovatriptanDrug

    Also called Frova

    frovatriptan 5mg tab during premonitory phase of migraine

Study groups in NCT00846495
Study groupRoleWhat they receive
topiramateActive comparatorSubjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily.
Receives: Drug: topiramate
frovatriptanActive comparatorSubjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).
Receives: Drug: frovatriptan

What is being measured

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

  1. Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate

    Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2

    Measured: Treatment Month 2

  2. Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine

    Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine

    Measured: Treatment Month 2

Secondary outcomes (6)

  1. Number of Headache Days Each Month Following Initiation of Treatment With Study Medication

    Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication

    Measured: 2 Months

  2. Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm

    Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2

    Measured: 2 Months

  3. Quality of Life in Subjects Utilizing Each Treatment Paradigm

    Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.

    Measured: Randomization, End of Treatment Month 1, End of Treatment Month 2

  4. Participant Satisfaction With Study Medications

    Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.

    Participants completed the PPMQ 24 hours following each first dose of frovatriptan.

    Measured: Treatment Month 2

  5. Adverse Events Associated With Study Medications

    Includes Adverse Events at or above 5% frequency per group.

    Measured: Treatment Months 1 and 2

  6. Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine

    Average cost of study medication taken by each subject. Measured in dollars.

    Measured: Treatment Months 1 and 2

Timeline

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

  1. First posted18 Feb 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJan 2011
  4. Study completionJan 2011

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00846495
Sponsor's protocol ID
Frova vs. Topiramate
Status last verified
Jan 2012
First submitted
17 Feb 2009
Last updated
13 Jan 2012
Data monitoring committee
No

Publications

  • Luciani R, Carter D, Mannix L, Hemphill M, Diamond M, Cady R. Prevention of migraine during prodrome with naratriptan. Cephalalgia. 2000 Mar;20(2):122-6. doi: 10.1046/j.1468-2982.2000.00030.x.

    PubMed 10961768

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing topiramate and frovatriptan in people with Migraine, run by Clinvest at 2 sites in United States.

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 10 inclusion and 23 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 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate (time frame: Treatment Month 2). The study lists 2 primary outcomes in all. 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 NCT00846495, which also lists 1 linked publication.

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 13 Jan 2012.

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