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

NCT00846495 | Completed Phase 4 Results

• 1 other identifier: Frova vs. Topiramate
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Migraine

Keywords

Migraine; Migraine prevention; Prodrome; Premonitory phase; Preemptive therapy

Outcome Measures

Primary Outcomes (2)

• 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

  Treatment Month 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

  Treatment Month 2

Secondary Outcomes (6)

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

  2 Months

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

  2 Months

• Quality of Life in Subjects Utilizing Each Treatment Paradigm

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

• Participant Satisfaction With Study Medications

  Treatment Month 2

• Adverse Events Associated With Study Medications

  Treatment Months 1 and 2

Study Arms (2)

topiramate

ACTIVE COMPARATOR

Subjects 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.

Drug: topiramate

frovatriptan

ACTIVE COMPARATOR

Subjects 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).

Drug: frovatriptan

Interventions

topiramate DRUG

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

Also known as: Topamax

topiramate

frovatriptan DRUG

frovatriptan 5mg tab during premonitory phase of migraine

Also known as: Frova

frovatriptan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• History of ergotamine, "triptan", or analgesic abuse within past 3 months

Sponsors & Collaborators

• Clinvest: lead
• Endo Pharmaceuticals: collaborator

Study Sites (2)

Physician Associates LLC

Oviedo, Florida, 32765, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Related Publications (1)

• 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.

  PMID: 10961768 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Topiramate; frovatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Results Point of Contact

• Title: Rebecca Browning
• Organization: Clinvest

rbrowning@clinvest.com

417-841-3664

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 13, 2012
• Results First Posted: August 9, 2011

Record last verified: 2012-01

Locations

US (2)