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

NCT00898677 | Completed Phase 3 Results

• 2 other identifiers: 0462-0302009_591
• Study Type: interventional
• Target: 1,268
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Pain Free at 2 Hours After Dose

  2 hours after dose

• Functional Status at 2 Hours After Dose

  2 hours after dose

• Nausea at 2 Hours After Dose

  2 hours after dose

Study Arms (4)

1

EXPERIMENTAL

rizatriptan 5 mg

Drug: rizatriptan benzoate

2

EXPERIMENTAL

rizatriptan 10 mg

Drug: rizatriptan benzoate

3

ACTIVE COMPARATOR

sumatriptan 100 mg

Drug: Comparator: sumatriptan

4

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Interventions

rizatriptan benzoate DRUG

single dose administration of 5mg rizatriptan (by Mouth) p.o.

Also known as: rizatriptan, MK0462

1

Comparator: sumatriptan DRUG

single dose administration of sumatriptan 100 p.o.

Also known as: sumatriptan

3

Comparator: Placebo DRUG

placebo to rizatriptan

4

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related 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.

  PMID: 19222588 BACKGROUND

• 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-Dec;38(10):748-55. doi: 10.1046/j.1526-4610.1998.3810748.x.

  PMID: 11284463 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: September 1, 1995
• Primary Completion: May 1, 1996
• Study Completion: September 1, 1996
• Last Updated: February 3, 2022
• Results First Posted: July 14, 2009

Record last verified: 2022-02