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

Acute Migraine Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894556
• Other study ID #: 0462-087
• Secondary ID: 2009_587
• Status: Completed
• Phase: Phase 3
• Start date: June 10, 2009
• Est. completion date: January 12, 2010

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 12, 2010
• Est. primary completion date: January 12, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Drug:
• rizatriptan
Single dose of 10 mg orally disintegrating tablet at onset of migraine attack
• Comparator: Placebo
Placebo to Rizatriptan
• Comparator: Sumatriptan
single dose of generic sumatriptan 100 mg at onset of migraine attack

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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):7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief (PR)	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.	2 hours post dose
Secondary	Pain Freedom (PF)	Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.	2 hours post dose