MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

NCT00897104 | Completed Phase 3 Results

• 2 other identifiers: 0462-0292009_593
• Study Type: interventional
• Target: 933
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (2)

• Pain Relief at 2 Hours After Treatment

  Participants 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 treatment

• Time to Relief Within 2 Hours After Treatment

  Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).

  within 2 hours after treatment

Secondary Outcomes (5)

• Pain Free at 2 Hours After Treatment

  2 hours after treatment

• Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities

  2 hours after treatment

• Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment

  2 hours after treatment

• Participants Who Used Escape Medication 2 Hours After the Treatment Dose

  2 hours after treatment

• Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])

  24 hours

Study Arms (3)

1

EXPERIMENTAL

Rizatriptan

Drug: rizatriptan benzoate (MK0462)

2

EXPERIMENTAL

Sumatriptan

Drug: Comparator: sumatriptan

3

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

rizatriptan benzoate (MK0462) DRUG

single dose 5 mg rizatriptan p.o.

Also known as: MK0462

1

Comparator: sumatriptan DRUG

single dose 50 mg sumatriptan p.o.

2

Comparator: Placebo DRUG

Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

3

Eligibility Criteria

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

You may qualify if:

• Participant had at least a 6-month history of migraine, with or without aura
• Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions
• Participant was judged to be in good health, apart from migraine

You may not qualify if:

• Participant was Pregnant or a nursing mother
• Participant had a history or current evidence of drug or alcohol abuse
• Participant had a history or clinical evidence of cardiovascular disease
• Participant had a clinically significant Electrocardiography (ECG) abnormality
• Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
• Participant had received treatment with an investigational device or compound within 30 days of the study
• Participant typically suffered from less then 1 or more than 8 attacks of migraine per month
• Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
• Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (3)

• Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia. 2009 Jul;29(7):711-8. doi: 10.1111/j.1468-2982.2008.01788.x. Epub 2009 Feb 3.

  PMID: 19210513 BACKGROUND

• Ferrari MD, Loder E, McCarroll KA, Lines CR. Meta-analysis of rizatriptan efficacy in randomized controlled clinical trials. Cephalalgia. 2001 Mar;21(2):129-36. doi: 10.1046/j.1468-2982.2001.00169.x.

  PMID: 11422095 RESULT

• Block GA, Goldstein J, Polis A, Reines SA, Smith ME. Efficacy and safety of rizatriptan versus standard care during long-term treatment for migraine. Rizatriptan Multicenter Study Groups. Headache. 1998 Nov-Dec;38(10):764-71. doi: 10.1046/j.1526-4610.1998.3810764.x.

  PMID: 11284464 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

rizatriptan

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No limitations were encountered in this study.

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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: August 1, 1995
• Primary Completion: May 1, 1996
• Study Completion: September 1, 1996
• Last Updated: February 3, 2022
• Results First Posted: July 23, 2010

Record last verified: 2022-02