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

Migraine Headache Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897104
• Other study ID #: 0462-029
• Secondary ID: 2009_593
• Status: Completed
• Phase: Phase 3
• Start date: August 1995
• Est. completion date: September 1996

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: September 1996
• Est. primary completion date: May 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• rizatriptan benzoate (MK0462)
single dose 5 mg rizatriptan p.o.
• Comparator: sumatriptan
single dose 50 mg sumatriptan p.o.
• Comparator: Placebo
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain Free at 2 Hours After Treatment	Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).	2 hours after treatment
Secondary	Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities	Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).	2 hours after treatment
Secondary	Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment	Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.	2 hours after treatment
Secondary	Participants Who Used Escape Medication 2 Hours After the Treatment Dose	Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.	2 hours after treatment
Secondary	Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])	Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence	24 hours