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

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ClinicalTrials.gov Identifier: NCT00897104
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 23, 2010
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Drug: rizatriptan benzoate (MK0462)
Drug: Comparator: sumatriptan
Drug: Comparator: Placebo
Enrollment 933
Recruitment Details

Participants were recruited at 31 sites: 6 in UK, 9 in Norway, 2 in Switzerland, and 14 in Sweden

First Participant Treated: August 1995

Last Participant Treated: May 1996.

Pre-assignment Details Participants screened at a pretreatment visit were given allocated drug supply with instructions. If participants had not treated an attack within 2 months of being enrolled, they were required to return for a rescreen visit. If by 4 months after being enrolled participants still had not treated an attack, they were discontinued from the study.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description Rizatriptan 5 mg orally once for treatment of single migraine attack Sumatriptan 5 mg orally once for treatment of single migraine attack Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Period Title: Overall Study
Started 418 [1] 428 [1] 87 [1]
Participants Treated 355 [2] 357 [2] 80 [2]
Participants Not Treated 63 [3] 71 [3] 7 [3]
Completed 354 [4] 357 [4] 79 [4]
Not Completed 64 71 8
Reason Not Completed
Lost to Follow-up             12             17             2
Pregnancy             0             1             0
Protocol Violation             0             1             0
Withdrawal by Subject             23             27             3
Abnormal Prestudy Labs             2             0             0
Abnormal Baseline ECG             2             2             0
Need for Concom. Med.             0             1             1
Lack of Migraine Attack             20             22             1
No Longer Met Inc/Exc Criteria             1             0             0
Not Specified             3             0             0
Protocol Violation             1             0             0
Withdrawal by Subject             0             0             1
[1]
Participants who were allocated study drug
[2]
Participants who took study drug
[3]
Participants who did not take study drug
[4]
Participants who took study drug and completed the study
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo Total
Hide Arm/Group Description Rizatriptan 5 mg orally once for treatment of single migraine attack Sumatriptan 5 mg orally once for treatment of single migraine attack Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack Total of all reporting groups
Overall Number of Baseline Participants 355 357 80 792
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 355 participants 357 participants 80 participants 792 participants
39.9  (10.3) 41.8  (10.1) 44.3  (10.5) 41.2  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 355 participants 357 participants 80 participants 792 participants
Female
291
  82.0%
291
  81.5%
70
  87.5%
652
  82.3%
Male
64
  18.0%
66
  18.5%
10
  12.5%
140
  17.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 357 participants 80 participants 792 participants
Caucasian 352 356 80 788
Asian 3 1 0 4
Baseline Headache Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 355 participants 357 participants 80 participants 792 participants
Grades 0,1: no pain, Mild, or missing 6 8 0 14
Grade 2: Moderate 216 221 51 488
Grade 3: Severe 133 128 29 290
[1]
Measure Description: Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
1.Primary Outcome
Title Pain Relief at 2 Hours After Treatment
Hide Description 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
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 352 356 80
Measure Type: Number
Unit of Measure: Participants
2-hour pain relief 223 238 18
No 2-hour pain relief 129 118 62
2.Primary Outcome
Title Time to Relief Within 2 Hours After Treatment
Hide Description 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).
Time Frame within 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 352 356 80
Measure Type: Number
Unit of Measure: Participants
First pain relief within 2 hrs 231 247 24
Pain relief did not occur within 2 hrs 121 109 56
3.Secondary Outcome
Title Pain Free at 2 Hours After Treatment
Hide Description 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).
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-participants-treated” approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 352 356 80
Measure Type: Number
Unit of Measure: Participants
2-hour pain freedom 95 113 2
No 2-hour pain freedom 257 243 78
4.Secondary Outcome
Title Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities
Hide Description 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).
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 350 355 80
Measure Type: Number
Unit of Measure: Participants
Normal 108 116 4
Mildly Impaired 152 148 28
Severely Impaired 38 42 18
Required Bed Rest 52 49 30
5.Secondary Outcome
Title Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment
Hide Description Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
“All-participants-treated” approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 350 354 80
Measure Type: Number
Unit of Measure: Participants
2-hour Photophobia 161 153 66
No 2-hour Photophobia 189 201 14
2-hour Phonophobia 126 125 47
No 2-hour Phonophobia 224 229 33
2-hour Nausea 105 131 48
No 2-hour Nausea 243 221 30
Not Analyzed for Nausea 2 2 2
2-hour Vomiting 12 12 6
No 2-hour Vomiting 330 330 67
Not Analyzed for Vomiting 8 12 7
6.Secondary Outcome
Title Participants Who Used Escape Medication 2 Hours After the Treatment Dose
Hide Description Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
Time Frame 2 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 355 357 80
Measure Type: Number
Unit of Measure: Participants
Used Escape Medication 73 55 33
Did not Use Escape Medication 282 302 47
7.Secondary Outcome
Title Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])
Hide Description 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
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The 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.
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description:
Rizatriptan 5 mg orally once for treatment of single migraine attack
Sumatriptan 5 mg orally once for treatment of single migraine attack
Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
Overall Number of Participants Analyzed 84 80 6
Mean (Standard Deviation)
Unit of Measure: Hours
11.07  (6.56) 11.58  (5.86) 14.38  (5.00)
Time Frame During the 24 hours treatment period, and up to and including 7 days after the last dose of study therapy.
Adverse Event Reporting Description

Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.

The At Risk population are the participants that received study treatment.

 
Arm/Group Title Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Hide Arm/Group Description Rizatriptan 5 mg orally once for treatment of single migraine attack Sumatriptan 5 mg orally once for treatment of single migraine attack Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
All-Cause Mortality
Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/355 (0.00%)   0/357 (0.00%)   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rizatriptan 5 mg Sumatriptan 5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/355 (25.92%)   108/357 (30.25%)   16/80 (20.00%) 
Cardiac disorders       
Palpitation * 1  2/355 (0.56%)  6/357 (1.68%)  0/80 (0.00%) 
Tachycardia * 1  2/355 (0.56%)  2/357 (0.56%)  1/80 (1.25%) 
Gastrointestinal disorders       
Dry Mouth * 1  10/355 (2.82%)  9/357 (2.52%)  0/80 (0.00%) 
Dyspepsia * 1  1/355 (0.28%)  1/357 (0.28%)  2/80 (2.50%) 
Nausea * 1  13/355 (3.66%)  21/357 (5.88%)  2/80 (2.50%) 
Pain, Mouth * 1  0/355 (0.00%)  0/357 (0.00%)  1/80 (1.25%) 
Vomiting * 1  2/355 (0.56%)  5/357 (1.40%)  0/80 (0.00%) 
General disorders       
Asthenia/Fatigue * 1  25/355 (7.04%)  18/357 (5.04%)  1/80 (1.25%) 
Fever * 1  1/355 (0.28%)  1/357 (0.28%)  1/80 (1.25%) 
Pain, Abdominal * 1  4/355 (1.13%)  5/357 (1.40%)  0/80 (0.00%) 
Pain, Chest * 1  8/355 (2.25%)  16/357 (4.48%)  0/80 (0.00%) 
Warm Sensation * 1  4/355 (1.13%)  3/357 (0.84%)  1/80 (1.25%) 
Musculoskeletal and connective tissue disorders       
Heaviness, Regional * 1  3/355 (0.85%)  4/357 (1.12%)  0/80 (0.00%) 
Pain, Back * 1  0/355 (0.00%)  4/357 (1.12%)  0/80 (0.00%) 
Pain, Neck * 1  2/355 (0.56%)  7/357 (1.96%)  2/80 (2.50%) 
Stiffness * 1  1/355 (0.28%)  5/357 (1.40%)  0/80 (0.00%) 
Strain * 1  0/355 (0.00%)  0/357 (0.00%)  1/80 (1.25%) 
Nervous system disorders       
Dizziness * 1  13/355 (3.66%)  17/357 (4.76%)  4/80 (5.00%) 
Headache * 1  7/355 (1.97%)  6/357 (1.68%)  0/80 (0.00%) 
Hypesthesia * 1  4/355 (1.13%)  6/357 (1.68%)  3/80 (3.75%) 
Mental Acuity Decreased * 1  3/355 (0.85%)  5/357 (1.40%)  1/80 (1.25%) 
Paresthesia * 1  11/355 (3.10%)  12/357 (3.36%)  2/80 (2.50%) 
Vertigo * 1  6/355 (1.69%)  3/357 (0.84%)  1/80 (1.25%) 
Psychiatric disorders       
Apathy * 1  1/355 (0.28%)  1/357 (0.28%)  1/80 (1.25%) 
Dream Abnormality * 1  0/355 (0.00%)  2/357 (0.56%)  1/80 (1.25%) 
Somnolence * 1  13/355 (3.66%)  17/357 (4.76%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Discomfort, Pharyngeal * 1  5/355 (1.41%)  5/357 (1.40%)  0/80 (0.00%) 
Dyspnea * 1  0/355 (0.00%)  2/357 (0.56%)  1/80 (1.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CRISP Dictionary
No limitations were encountered in this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00897104     History of Changes
Other Study ID Numbers: 0462-029
2009_593
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: September 26, 2009
Results First Posted: July 23, 2010
Last Update Posted: March 4, 2015