Two Rizatriptan Prescribing Portions for Treatment of Migraine

NCT00397254 | Completed Phase 4 Results

• 1 other identifier: 078-00
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.

Conditions

Migraine

Keywords

Migraine; rizatriptan

Outcome Measures

Primary Outcomes (1)

• Number of Days With Migraine

  6 months

Secondary Outcomes (7)

• Number of Migraine Attacks

  6 months

• Percentage of Responders

  6 months

• Average Attack Duration

  6 months

• Headache Severity of All Attacks

  6 months

• Percentage of Attacks With Symptom Elimination at 2 Hours

  6 months

Study Arms (2)

Clinical Limit

ACTIVE COMPARATOR

Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg ODT: 27 tablets per month.

Drug: rizatriptan

Formulary Limit

ACTIVE COMPARATOR

Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg ODT: 9 tablets per month.

Drug: rizatriptan

Interventions

rizatriptan DRUG

10mg ODT 27 tablets

Also known as: Maxalt

Clinical Limit

Eligibility Criteria

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

You may qualify if:

• Patient is at least 18 years of age
• Patient has at least a 1-year history of migraine with or without aura by International Headache Society (IHS) criteria 1.1 and 1.2
• Patient typically has 3-8 migraine attacks/month
• Patient has less than 10 headache days/month with no evidence of IHS 8.2 Medication Overuse Headache
• Patient receives their triptan medication under a pre-determined prescribing allocation ranging from 6-12 tablets per month for the last 3 months preceding Visit 1.
• Patient and investigator agree that multiple doses of rizatriptan described in the package circular are appropriate for non-responsive or recurring headache.
• Patient uses a triptan as mainstay of acute therapy at Visit 1.
• Patient 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 rizatriptan outside the study.
• Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.

You may not qualify if:

• Patient has headache disorders beyond migraine or episodic tension-type headache IHS 2.1
• Patient is receiving prophylactic therapy for migraine
• Patient is currently taking:
• Daily or nearly daily (typically \>3 days out of 7 days) use of non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or other analgesics. Aspirin less than or equal to 325mg daily is allowed for cardioprotection.
• Monoamine oxidase inhibitors (MAOIs) Propranolol Patient taking either an MAOI ro propranolol may be enrolled in the study, if in the clinical judgement of the investigator, either of these medications can be discontinued 2 weeks prior to study entry. Otherwise the use of MAOIs and propranolol are prohibited during the study.
• Patient has basilar or hemiplegic migraine headache.
• Patient has history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or finding consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease.
• Patient has uncontrolled hypertension.
• Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients.
• Patient is pregnant or a nursing mother.
• Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
• Patient has received treatment with an investigational device or compound within 30 days of the study (Visit 1).
• Patient had clinical evidence of significant pulmonary, renal, hepatic, endocrine, neurologic (apart from migraine), psychiatric or any other condition that, in the opinion of the investigator may confound the results of the study, pose an additional risk, or interfere with optimal participation in the study.

Sponsors & Collaborators

• Clinvest: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (10)

Brian Koffman, MD

Diamond Bar, California, 91765, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Physician Associates

Oviedo, Florida, 32765, United States

Location

Dr. B. Abraham, PC

Snellville, Georgia, 33039, United States

Location

Dhiren Shah, MD

Prince Frederick, Maryland, 20678, United States

Location

Westside Family Medical Center

Kalamazoo, Michigan, 49009, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Mercy Health Research / Ryan Headache Center

St Louis, Missouri, 63141, United States

Location

PharmQuest

Greensboro, North Carolina, 27401, United States

Location

Thomas Jefferson University Hospital Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Brandes JL, Visser WH, Farmer MV, Schuhl AL, Malbecq W, Vrijens F, Lines CR, Reines SA; Protocol 125 study group. Montelukast for migraine prophylaxis: a randomized, double-blind, placebo-controlled study. Headache. 2004 Jun;44(6):581-6. doi: 10.1111/j.1526-4610.2004.446006.x.

  PMID: 15186302 BACKGROUND

• Cady RK, Goldstein J, Silberstein S, Juhasz M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. doi: 10.1111/j.1526-4610.2009.01532.x. Epub 2009 Oct 8.

  PMID: 19817885 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: M.E. Beach
• Organization: Clinvest

mbeach@clinvest.com

417-841-3618

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 9, 2006
• Study Start: December 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 8, 2010
• Results First Posted: September 22, 2009

Record last verified: 2009-09

Locations

US (10)