Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Migraine Headache Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898677
• Other study ID #: 0462-030
• Secondary ID: 2009_591
• Status: Completed
• Phase: Phase 3
• Start date: September 1995
• Est. completion date: September 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 compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: September 1996
• Est. primary completion date: May 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 Electrocardiography (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 hypersensitivity to sumatriptan

• Patient had participated in any previous study involving rizatriptan

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
• rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
• Comparator: sumatriptan
single dose administration of sumatriptan 100 p.o.
• Comparator: Placebo
placebo to rizatriptan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (2)

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

Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Rizatriptan 030 Study Group. Headache. 1998 Nov- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief at 2 Hours After Dose	Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment	2 hours after dose
Primary	Time to Relief Within 2 Hours After Dose	Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose	within 2 hours after dose
Secondary	Pain Free at 2 Hours After Dose	Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).	2 hours after dose
Secondary	Functional Status at 2 Hours After Dose	Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).	2 hours after dose
Secondary	Nausea at 2 Hours After Dose	Patients who recorded the presence or absence of nausea 2 hours after dose	2 hours after dose