Drug Study in Pediatric Subjects With Migraines

This study has been completed.

Study NCT00604812 Information provided by Merck

First Received: October 17, 2007 Last Updated: September 2, 2009 History of Changes

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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	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

Participant Flow: Overall Study

	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

Reporting Groups

	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)

Baseline Measures

	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]
Female	5	8	13
Male	7	5	12
Weight [units: participants]
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 ]

Show Outcome Measure 1

2. Secondary:

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞)) [ 24 Hours ]

Show Outcome Measure 2

3. Secondary:

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Maximum Concentration (Cmax) [ 24 Hours ]

Show Outcome Measure 3

4. Secondary:

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax) [ 24 Hours ]

Show Outcome Measure 4

5. Secondary:

Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Apparent Half-life (Apparent t½) [ 24 Hours ]

Show Outcome Measure 5