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

NCT00894556 | Completed Phase 3 Results

• 2 other identifiers: 0462-0872009_587
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acute Migraine

Keywords

Treatment of acute migraine with or without aura in adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Freedom (PF)

  2 hours post dose

Study Arms (4)

Treatment Sequence A

EXPERIMENTAL

Rizatriptan - Rizatriptan - Placebo

Drug: rizatriptan; Drug: Comparator: Placebo

Treatment Sequence B

EXPERIMENTAL

Rizatriptan - Placebo - Rizatriptan

Drug: rizatriptan; Drug: Comparator: Placebo

Treatment Sequence C

EXPERIMENTAL

Placebo - Rizatriptan - Rizatriptan

Drug: rizatriptan; Drug: Comparator: Placebo

Baseline Phase

OTHER

Sumatriptan

Drug: Comparator: Sumatriptan

Interventions

rizatriptan DRUG

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

Treatment Sequence A; Treatment Sequence B; Treatment Sequence C

Comparator: Placebo DRUG

Placebo to Rizatriptan

Treatment Sequence A; Treatment Sequence B; Treatment Sequence C

Comparator: Sumatriptan DRUG

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

Baseline Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related 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):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.

  PMID: 21078681 RESULT

MeSH Terms

Interventions

rizatriptan

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: June 10, 2009
• Primary Completion: January 12, 2010
• Study Completion: January 12, 2010
• Last Updated: May 10, 2024
• Results First Posted: January 20, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share