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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Condition: |
Migraine Disorders |
| Interventions: |
Drug: rizatriptan benzoate (5 mg) Drug: rizatriptan benzoate (10 mg) 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 |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Panel A - 5 mg Rizatriptan | Rizatriptan 5 mg once orally |
| Panel A - Placebo | Placebo closely matching 5 mg rizatriptan once orally |
| Panel B - 10 mg Rizatriptan | Rizatriptan 10 mg once orally |
| Panel B - Placebo | Placebo exactly matching 10 mg rizatriptan once orally |
| Panel A - 5 mg Rizatriptan | Panel A - Placebo | Panel B - 10 mg Rizatriptan | Panel B - Placebo | |
|---|---|---|---|---|
| STARTED | 9 | 3 | 10 | 3 |
| COMPLETED | 9 | 3 | 10 | 3 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Panel A | Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3) |
| Panel B | Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3) |
| Panel A | Panel B | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
12 | 13 | 25 |
|
Age [units: years] Mean ± Standard Deviation |
8.50 ± 1.44 | 14.54 ± 2.14 | 11.64 ± 3.56 |
|
Gender [units: participants] |
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| Female | 5 | 8 | 13 |
| Male | 7 | 5 | 12 |
|
Weight [units: participants] |
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| 20-39 kg | 7 | 5 | 12 |
| ≥ 40 kg | 5 | 8 | 13 |
Outcome Measures
| 1. Primary: | Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs [ 24 Hours ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs |
| Measure Description | All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis) |
| Time Frame | 24 Hours |
| Safety Issue | Yes |
| 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. |
|---|
| All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability. |
| Description | |
|---|---|
| Panel A | 5 mg Rizatriptan |
| Panel B | 10 mg Rizatriptan |
| Placebo | Combined Placebo groups from panels A & B |
| Panel A | Panel B | Placebo | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
9 | 10 | 6 |
|
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
[units: Participants] |
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| Serious Adverse Events | 0 | 0 | 0 |
| Non-Serious Adverse Events | 3 | 5 | 3 |
| No Adverse Events Reported | 6 | 5 | 3 |
| 2. Secondary: | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) [ 24 Hours ] |
| 3. Secondary: | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax) [ 24 Hours ] |
| 4. Secondary: | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax) [ 24 Hours ] |
| 5. Secondary: | Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent Half-life (Apparent t½) [ 24 Hours ] |
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 |
|---|
| Pharmacokinetic data presented are preliminary data. |
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_601, MK0462-083 |
| Study First Received: | October 17, 2007 |
| Results First Received: | June 3, 2009 |
| Last Updated: | September 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00604812 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
