Clinical trial NCT00846495: Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
Official title: A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Migraine prevention
Prodrome
Premonitory phase
Preemptive therapy
Lead sponsor: Cady, Roger, M.D.
Sponsor class: INDIV
Collaborators: name: Endo Pharmaceuticals
First posted: 2009-02-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: INCLUSION CRITERIA

1. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)
2. Subject has a 3-month history of averaging 3-6 migraines per month
3. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches
4. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.
5. Male or female at least 18 years of age
6. 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.
7. 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.
8. Subject is able to understand instructions for the study and complete the diary
9. Subject is willing to give informed consent to participate in the study
10. Any migraine prophylactic medication must have a stabilized dosage for one month

EXCLUSION CRITERIA

1. 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
   * 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.
2. History of ergotamine, "triptan", or analgesic abuse within past 3 months
3. History of current or recent drug or alcohol abuse that would interfere with participation in the study.
4. More than 15 headache days per month within past 3 months.
5. Women who are pregnant or breast feeding
6. Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication
7. 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.
8. Subject is on a ketogenic diet
9. Participation in another investigative drug study within the previous 30 days
10. Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.

Primary outcomes:
measure: Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
timeFrame: Treatment Month 2
measure: Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
timeFrame: Treatment Month 2
Secondary outcomes:
measure: Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
timeFrame: 2 Months
measure: Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
timeFrame: 2 Months
measure: Quality of Life in Subjects Utilizing Each Treatment Paradigm
timeFrame: Randomization, End of Treatment Month 1, End of Treatment Month 2
measure: Participant Satisfaction With Study Medications
timeFrame: Treatment Month 2
measure: Adverse Events Associated With Study Medications
timeFrame: Treatment Months 1 and 2
measure: Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
timeFrame: Treatment Months 1 and 2
Other outcomes:
Locations:
city: Oviedo
country: United States
facility: Physician Associates LLC
state: Florida
city: Springfield
country: United States
facility: Clinvest
state: Missouri
Study officials:
affiliation: Clinvest
name: Roger K Cady, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.