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Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00516737
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : April 14, 2009
Last Update Posted : June 9, 2017
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
Interventions Drug: Comparator: rizatriptan benzoate
Drug: Comparator: Placebo
Enrollment 207
Recruitment Details Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)
Pre-assignment Details 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 Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack Matching placebo; one dose, treatment of a single migraine attack
Period Title: Overall Study
Started 103 104
Completed 92 96
Not Completed 11 8
Reason Not Completed
Lost to Follow-up             2             0
Physician Decision             0             1
Withdrawal by Subject             0             1
Lack of Qualifying Event             9             6
Arm/Group Title Rizatriptan 10 mg ODT Placebo Total
Hide Arm/Group Description Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack Matching placebo; one dose, treatment of a single migraine attack Total of all reporting groups
Overall Number of Baseline Participants 103 104 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 103 participants 104 participants 207 participants
41
(19 to 69)
44
(18 to 66)
42.5
(18 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 104 participants 207 participants
Female
90
  87.4%
96
  92.3%
186
  89.9%
Male
13
  12.6%
8
   7.7%
21
  10.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 103 participants 104 participants 207 participants
Black or African American 4 3 7
White 95 100 195
Asian 2 1 3
Multi-Racial 2 0 2
1.Primary Outcome
Title Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Hide Description Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
61 27
2.Secondary Outcome
Title Number of Participants With 24-Hour Sustained Pain Freedom
Hide Description 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population was used for this secondary variable of 24-hour sustained pain freedom, unless participants were otherwise identified as non-responders for this endpoint (i.e., took rescue up to 24 hours post-dose or were not pain free at 2 hours post-dose). To be included, participants must have also had a non-missing 24-hour assessment.
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
48 17
3.Secondary Outcome
Title Number of Participants With no Rescue Use up to 24 Hours Post-Dose
Hide Description Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all randomized and treated participants.
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
61 32
4.Secondary Outcome
Title Number of Participants With Absence of Photophobia at 2 Hours Post-dose
Hide Description Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
69 43
5.Secondary Outcome
Title Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
Hide Description Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
72 55
6.Secondary Outcome
Title Number of Participants With Absence of Nausea at 2 Hours Post-dose
Hide Description Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose.
Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
82 73
7.Secondary Outcome
Title Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
Hide Description

Level of functional disability was assessed on a paper diary by the participants.

Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose.

Time Frame 2 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description:
Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Matching placebo; one dose, treatment of a single migraine attack
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: Participants
66 42
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rizatriptan 10 mg ODT Placebo
Hide Arm/Group Description Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack Matching placebo; one dose, treatment of a single migraine attack
All-Cause Mortality
Rizatriptan 10 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rizatriptan 10 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/96 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rizatriptan 10 mg ODT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/92 (6.52%)   3/96 (3.13%) 
Gastrointestinal disorders     
Hyperchlorhydria * 1  2/92 (2.17%)  0/96 (0.00%) 
Nausea * 1  1/92 (1.09%)  0/96 (0.00%) 
General disorders     
Fatigue * 1  0/92 (0.00%)  1/96 (1.04%) 
Feeling cold * 1  0/92 (0.00%)  1/96 (1.04%) 
Feeling jittery * 1  1/92 (1.09%)  0/96 (0.00%) 
Pain * 1  1/92 (1.09%)  0/96 (0.00%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  1/92 (1.09%)  0/96 (0.00%) 
Nervous system disorders     
Balance disorder * 1  1/92 (1.09%)  0/96 (0.00%) 
Dizziness * 1  2/92 (2.17%)  1/96 (1.04%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/92 (0.00%)  1/96 (1.04%) 
Throat tightness * 1  1/92 (1.09%)  0/96 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.
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.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00516737     History of Changes
Other Study ID Numbers: 0462-081
2007_547
First Submitted: August 13, 2007
First Posted: August 15, 2007
Results First Submitted: March 12, 2009
Results First Posted: April 14, 2009
Last Update Posted: June 9, 2017