A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)
Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00246337
Collaborator
(none)
420
9
5.9
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
Study Start Date
:
Nov 1, 2005
Actual Primary Completion Date
:
May 1, 2006
Actual Study Completion Date
:
May 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. |
Drug: Comparator: Placebo
Placebo to match assigned treatment arm; one orally-administered dose
|
| Experimental: MK0974 25 mg MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 25 mg; one orally-administered dose
|
| Experimental: MK0974 50 mg MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 50 mg; one orally-administered dose
|
| Experimental: MK0974 100 mg MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 100 mg; one orally-administered dose
|
| Experimental: MK0974 200 mg MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 200 mg; one orally-administered dose
|
| Experimental: MK0974 300 mg MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 300 mg; one orally-administered dose
|
| Experimental: MK0974 400 mg MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 400 mg; one orally-administered dose
|
| Experimental: MK0974 600 mg MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: MK0974
MK0974 600 mg; one orally-administered dose
|
| Active Comparator: Rizatriptan 10 mg Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
Drug: Rizatriptan
Rizatriptan 10 mg; one orally-administered dose
|
Outcome Measures
Primary Outcome Measures
- Pain Relief at 2 Hours [2 hours post dose]
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Secondary Outcome Measures
- Pain Freedom at 2 Hours [2 hours post dose]
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose.
- Sustained Pain Relief [2-24 hours post dose]
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
- Sustained Pain Freedom [2-24 hours post dose]
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patient has at least 1 year history of migraine (with or without aura)
-
Females of childbearing years must use acceptable contraception throughout trial
-
Patient is in general good health based on screening assessment
Exclusion Criteria:
-
Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
-
Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes or other significant disease
-
Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other then migraine)
-
Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
-
Patient has a history of cancer within the last 5 years
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00246337
Other Study ID Numbers:
- 0974-004
- 2005_082
First Posted:
Oct 30, 2005
Last Update Posted:
Nov 1, 2015
Last Verified:
Oct 1, 2015
Study Results
Participant Flow
| Recruitment Details | 20 centers from the United States participated. First Patient treated on 01 December 2005; Last Patient Last Treatment was on 01 May 2006. |
|---|---|
| Pre-assignment Detail | Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit. |
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Period Title: Overall Study | |||||||||
| STARTED | 147 | 16 | 18 | 17 | 16 | 54 | 54 | 53 | 45 |
| Completed Period (Initial Dose) | 46 | 4 | 9 | 5 | 8 | 29 | 29 | 27 | 19 |
| Completed Period (Both Doses) | 69 | 10 | 6 | 11 | 4 | 10 | 16 | 13 | 15 |
| COMPLETED | 115 | 14 | 15 | 16 | 12 | 39 | 45 | 40 | 34 |
| NOT COMPLETED | 32 | 2 | 3 | 1 | 4 | 15 | 9 | 13 | 11 |
Baseline Characteristics
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. The reported number of participants are all patients randomized who received study drug and completed the study. | Total of all reporting groups |
| Overall Participants | 115 | 14 | 15 | 16 | 12 | 39 | 45 | 40 | 34 | 330 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
42.2
(10.6)
|
43.0
(10.1)
|
41.5
(10.9)
|
40.9
(7.5)
|
34.3
(11.7)
|
40.5
(10.4)
|
40.1
(11.9)
|
44.5
(12.0)
|
40.2
(10.8)
|
41.5
(10.9)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
104
90.4%
|
11
78.6%
|
14
93.3%
|
14
87.5%
|
9
75%
|
34
87.2%
|
42
93.3%
|
36
90%
|
28
82.4%
|
292
88.5%
|
| Male |
11
9.6%
|
3
21.4%
|
1
6.7%
|
2
12.5%
|
3
25%
|
5
12.8%
|
3
6.7%
|
4
10%
|
6
17.6%
|
38
11.5%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||||||||
| White |
92
80%
|
10
71.4%
|
11
73.3%
|
11
68.8%
|
6
50%
|
29
74.4%
|
34
75.6%
|
38
95%
|
28
82.4%
|
259
78.5%
|
| Black |
18
15.7%
|
4
28.6%
|
3
20%
|
3
18.8%
|
5
41.7%
|
7
17.9%
|
10
22.2%
|
2
5%
|
5
14.7%
|
57
17.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
1
6.3%
|
0
0%
|
0
0%
|
1
2.2%
|
0
0%
|
0
0%
|
2
0.6%
|
| American Indian or Alaska Native |
1
0.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| European |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.9%
|
1
0.3%
|
| Hispanic American |
4
3.5%
|
0
0%
|
0
0%
|
1
6.3%
|
1
8.3%
|
3
7.7%
|
0
0%
|
0
0%
|
0
0%
|
9
2.7%
|
| Multi-Racial |
0
0%
|
0
0%
|
1
6.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Baseline Severity (Number) [Number] | ||||||||||
| Moderate |
81
70.4%
|
11
78.6%
|
9
60%
|
15
93.8%
|
6
50%
|
26
66.7%
|
34
75.6%
|
30
75%
|
27
79.4%
|
239
72.4%
|
| Severe |
34
29.6%
|
3
21.4%
|
6
40%
|
1
6.3%
|
6
50%
|
12
30.8%
|
11
24.4%
|
10
25%
|
7
20.6%
|
90
27.3%
|
| Baseline Severity data missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
Outcome Measures
| Title | Pain Relief at 2 Hours |
|---|---|
| Description | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack. |
| Time Frame | 2 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. |
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Measure Participants | 115 | 14 | 15 | 16 | 12 | 38 | 45 | 40 | 34 |
| Number [Participants] |
52
45.2%
|
5
35.7%
|
9
60%
|
8
50%
|
5
41.7%
|
25
64.1%
|
22
48.9%
|
27
67.5%
|
24
70.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg |
|---|---|---|
| Comments | Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85% | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | 0.05 is the pre-specified significance level. | |
| Method | generalized linear model | |
| Comments | The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo. | |
| Title | Pain Freedom at 2 Hours |
|---|---|
| Description | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain freedom is defined as no pain (Grade 0) at 2 hours post dose. |
| Time Frame | 2 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. |
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Measure Participants | 115 | 14 | 15 | 16 | 12 | 38 | 45 | 40 | 34 |
| Number [Participants] |
16
13.9%
|
3
21.4%
|
7
46.7%
|
3
18.8%
|
2
16.7%
|
17
43.6%
|
11
24.4%
|
13
32.5%
|
11
32.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg |
|---|---|---|
| Comments | Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | 0.05 is the pre-specified significance level. | |
| Method | generalized linear model | |
| Comments | The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo. | |
| Title | Sustained Pain Relief |
|---|---|
| Description | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. |
| Time Frame | 2-24 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing |
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Measure Participants | 115 | 13 | 15 | 16 | 11 | 38 | 45 | 40 | 34 |
| Number [Participants] |
27
23.5%
|
1
7.1%
|
9
60%
|
3
18.8%
|
3
25%
|
20
51.3%
|
17
37.8%
|
21
52.5%
|
12
35.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg |
|---|---|---|
| Comments | Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | 0.05 is the pre-specified significance level. | |
| Method | generalized linear model | |
| Comments | ||
| Title | Sustained Pain Freedom |
|---|---|
| Description | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. |
| Time Frame | 2-24 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Patients Treated (APT): included all randomized participants who took study medication and reported the post-dose assessment of the primary efficacy measure. Patients were counted in the treatment group to which they were randomized. One patient in the MK974 300 mg group was excluded because baseline headache severity information was missing. |
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. |
| Measure Participants | 115 | 13 | 15 | 16 | 11 | 38 | 45 | 40 | 34 |
| Number [Participants] |
12
10.4%
|
1
7.1%
|
7
46.7%
|
3
18.8%
|
1
8.3%
|
15
38.5%
|
10
22.2%
|
13
32.5%
|
6
17.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MK0974 300 mg, MK0974 400 mg, MK0974 600 mg |
|---|---|---|
| Comments | Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | 0.05 is the pre-specified significance level. | |
| Method | generalized linear model | |
| Comments | The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo. | |
Adverse Events
| Time Frame | Within 14 Days Post-Dose. The numbers in the Participant Flow reflect all patients randomized. | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | For safety, the population was based on actual treatment with any dose (first dose, or the optional second dose which they could take after 4 hours). Patients were counted based on actual treatment (including the optional second dose). If the patient was treated with both placebo and active, they were counted under the active treatment group. | |||||||||||||||||
| Arm/Group Title | Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg | |||||||||
| Arm/Group Description | Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | |||||||||
All Cause Mortality |
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| Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
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| Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/47 (2.1%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Appendicitis | 1/47 (2.1%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
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| Placebo | MK0974 25 mg | MK0974 50 mg | MK0974 100 mg | MK0974 200 mg | MK0974 300 mg | MK0974 400 mg | MK0974 600 mg | Rizatriptan 10 mg | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/47 (21.3%) | 4/17 (23.5%) | 9/19 (47.4%) | 4/27 (14.8%) | 7/18 (38.9%) | 9/51 (17.6%) | 12/52 (23.1%) | 14/49 (28.6%) | 10/50 (20%) | |||||||||
| Cardiac disorders | ||||||||||||||||||
| Sinus tachycardia | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Ear and labyrinth disorders | ||||||||||||||||||
| Tinnitus | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Eye disorders | ||||||||||||||||||
| Eye pain | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 1/50 (2%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| Dry mouth | 1/47 (2.1%) | 1/17 (5.9%) | 0/19 (0%) | 1/27 (3.7%) | 0/18 (0%) | 2/51 (3.9%) | 2/52 (3.8%) | 1/49 (2%) | 1/50 (2%) | |||||||||
| Flatulence | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 1/27 (3.7%) | 0/18 (0%) | 0/51 (0%) | 1/52 (1.9%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Nausea | 6/47 (12.8%) | 0/17 (0%) | 0/19 (0%) | 1/27 (3.7%) | 0/18 (0%) | 3/51 (5.9%) | 5/52 (9.6%) | 5/49 (10.2%) | 1/50 (2%) | |||||||||
| Vomiting | 1/47 (2.1%) | 1/17 (5.9%) | 0/19 (0%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 2/52 (3.8%) | 1/49 (2%) | 0/50 (0%) | |||||||||
| General disorders | ||||||||||||||||||
| Fatigue | 0/47 (0%) | 1/17 (5.9%) | 3/19 (15.8%) | 2/27 (7.4%) | 0/18 (0%) | 0/51 (0%) | 1/52 (1.9%) | 1/49 (2%) | 2/50 (4%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Upper respiratory tract infection | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 1/52 (1.9%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Investigations | ||||||||||||||||||
| Platelet count increased | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| Food craving | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| Musculoskeletal stiffness | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| Dizziness | 2/47 (4.3%) | 0/17 (0%) | 2/19 (10.5%) | 0/27 (0%) | 2/18 (11.1%) | 3/51 (5.9%) | 1/52 (1.9%) | 4/49 (8.2%) | 1/50 (2%) | |||||||||
| Dysgeusia | 1/47 (2.1%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 1/49 (2%) | 1/50 (2%) | |||||||||
| Hyperaesthesia | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 1/50 (2%) | |||||||||
| Paraesthesia | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 1/49 (2%) | 2/50 (4%) | |||||||||
| Somnolence | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 1/27 (3.7%) | 2/18 (11.1%) | 2/51 (3.9%) | 1/52 (1.9%) | 4/49 (8.2%) | 2/50 (4%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| Bruxism | 0/47 (0%) | 0/17 (0%) | 1/19 (5.3%) | 0/27 (0%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Restlessness | 0/47 (0%) | 0/17 (0%) | 0/19 (0%) | 0/27 (0%) | 1/18 (5.6%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| Rhinorrhoea | 0/47 (0%) | 1/17 (5.9%) | 0/19 (0%) | 1/27 (3.7%) | 0/18 (0%) | 0/51 (0%) | 0/52 (0%) | 0/49 (0%) | 0/50 (0%) | |||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | Vice President of Late Stage Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@spcorp.com |
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT00246337
Other Study ID Numbers:
- 0974-004
- 2005_082
First Posted:
Oct 30, 2005
Last Update Posted:
Nov 1, 2015
Last Verified:
Oct 1, 2015