Treatment of Multiple Attacks of Acute Migraine (0462-025)

Migraine Headache Clinical Trial

Official title:

A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899379
• Other study ID #: 0462-025
• Secondary ID: MK0462-0252009_5
• Status: Completed
• Phase: Phase 3
• Start date: April 1995
• Est. completion date: April 1996

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: April 1996
• Est. primary completion date: January 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient had at least a 6-month history of migraine, with or without aura

• Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.

• Patient was judged to be in good health, apart from migraine

Exclusion Criteria:

• Patient was pregnant or a nursing mother.

• Patient had abused drugs or alcohol within 12 months prior to entering the study

• Patient had a history of cardiovascular disease

• Patient had clinically significant ECG abnormality

• Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening

• Patient received treatment with an investigational device or compound within 30 days of the study start

• Patient typically suffered from less then 1 or more than 8 attacks of migraine per month

• Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches

• Patient had prior exposure to rizatriptan

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• rizatriptan benzoate
Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache
• Comparator: Placebo
Placebo to Rizatriptan, Oral Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (4)

Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. — View Citation

Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3. — View Citation

Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12. — View Citation

Kramer MS, Matzura-Wolfe D, Polis A, Getson A, Amaraneni PG, Solbach MP, McHugh W, Feighner J, Silberstein S, Reines SA. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Rizatriptan Multiple Attack Study G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief at 2 Hours During the First Migraine Attack Period	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack	2 hours
Secondary	Pain Relief at 2 Hours During the Second Migraine Attack Period	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack	2 hours
Secondary	Pain Relief at 2 Hours During the Third Migraine Attack Period	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack	2 hours
Secondary	Pain Relief at 2 Hours During the Fourth Migraine Attack Period	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack	2 hours