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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00897104
Other study ID # 0462-029
Secondary ID 2009_593
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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