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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Condition: |
Migraine |
| Interventions: |
Drug: Comparator: rizatriptan benzoate Drug: Comparator: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany) |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit. |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
| STARTED | 103 | 104 |
| COMPLETED | 92 | 96 |
| NOT COMPLETED | 11 | 8 |
| Lost to Follow-up | 2 | 0 |
| Physician Decision | 0 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Lack of Qualifying Event | 9 | 6 |
Baseline Characteristics
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
103 | 104 | 207 |
|
Age [units: years] Mean ( Full Range ) |
41 ( 19 to 69 ) |
44 ( 18 to 66 ) |
42.5 ( 18 to 69 ) |
|
Gender [units: participants] |
|||
| Female | 90 | 96 | 186 |
| Male | 13 | 8 | 21 |
|
Race/Ethnicity, Customized [units: participants] |
|||
| Black or African American | 4 | 3 | 7 |
| White | 95 | 100 | 195 |
| Asian | 2 | 1 | 3 |
| Multi-Racial | 2 | 0 | 2 |
Outcome Measures
| 1. Primary: | Number of Participants Who Are Pain Free at 2 Hours Post-Dose [ 2 hours post-dose ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Participants Who Are Pain Free at 2 Hours Post-Dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| 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). |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants Who Are Pain Free at 2 Hours Post-Dose
[units: Participants] |
61 | 27 |
| 2. Secondary: | Number of Participants With 24-Hour Sustained Pain Freedom [ 24 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With 24-Hour Sustained Pain Freedom |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| 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. |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With 24-Hour Sustained Pain Freedom
[units: Participants] |
48 | 17 |
| 3. Secondary: | Number of Participants With no Rescue Use up to 24 Hours Post-Dose [ 24 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With no Rescue Use up to 24 Hours Post-Dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The FAS population included all randomized and treated participants. |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With no Rescue Use up to 24 Hours Post-Dose
[units: Participants] |
61 | 32 |
| 4. Secondary: | Number of Participants With Absence of Photophobia at 2 Hours Post-dose [ 2 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Absence of Photophobia at 2 Hours Post-dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With Absence of Photophobia at 2 Hours Post-dose
[units: Participants] |
69 | 43 |
| 5. Secondary: | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose [ 2 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With Absence of Phonophobia at 2 Hours Post-dose
[units: Participants] |
72 | 55 |
| 6. Secondary: | Number of Participants With Absence of Nausea at 2 Hours Post-dose [ 2 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Absence of Nausea at 2 Hours Post-dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With Absence of Nausea at 2 Hours Post-dose
[units: Participants] |
82 | 73 |
| 7. Secondary: | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose [ 2 hours post-dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose |
| Measure 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 |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The FAS population included all randomized participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment). |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
92 | 96 |
|
Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose
[units: Participants] |
66 | 42 |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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. |
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_547, MK0462-081 |
| Study First Received: | August 13, 2007 |
| Results First Received: | March 12, 2009 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00516737 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
