A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)

NCT ID: NCT00894556

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-10
• Study Completion Date: 2010-01-12

Brief Summary

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

Conditions

Acute Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Sequence A

Rizatriptan - Rizatriptan - Placebo

Group Type: EXPERIMENTAL

rizatriptan

Intervention Type: DRUG

Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Comparator: Placebo

Intervention Type: DRUG

Placebo to Rizatriptan

Treatment Sequence B

Rizatriptan - Placebo - Rizatriptan

Group Type: EXPERIMENTAL

rizatriptan

Intervention Type: DRUG

Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Comparator: Placebo

Intervention Type: DRUG

Placebo to Rizatriptan

Treatment Sequence C

Placebo - Rizatriptan - Rizatriptan

Group Type: EXPERIMENTAL

rizatriptan

Intervention Type: DRUG

Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Comparator: Placebo

Intervention Type: DRUG

Placebo to Rizatriptan

Baseline Phase

Sumatriptan

Group Type: OTHER

Comparator: Sumatriptan

Intervention Type: DRUG

single dose of generic sumatriptan 100 mg at onset of migraine attack

Interventions

rizatriptan

Single dose of 10 mg orally disintegrating tablet at onset of migraine attack

Intervention Type: DRUG

Comparator: Placebo

Placebo to Rizatriptan

Intervention Type: DRUG

Comparator: Sumatriptan

single dose of generic sumatriptan 100 mg at onset of migraine attack

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
• Patient generally does not respond to treatment with sumatriptan
• Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
• Patient is able to complete paper diary

Exclusion Criteria

• Patient is pregnant or breast feeding or excepts to become pregnant during the study
• Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
• Patient has basilar or hemiplegic migraines
• Patient is unable to distinguish between migraine attacks from other types of headaches
• Patient has more than 15 headache-days per month
• Patient was greater than 50 years old at age of migraine onset
• Patient has failed to respond to 3 or more triptans
• Patient has a repeated history of failing to respond to or tolerate rizatriptan
• Patient uses opioids as primary migraine therapy
• Patient uses daily opioids
• Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
• Patient has uncontrolled hypertension
• Patient has a history of neoplastic disease
• Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
• Patient has a history of drug or alcohol abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.

Reference Type: RESULT

PMID: 21078681 (View on PubMed)

Other Identifiers

2009_587

Identifier Type: -

Identifier Source: secondary_id

0462-087

Identifier Type: -

Identifier Source: org_study_id