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

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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

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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

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1. Primary:

Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs [ 24 Hours ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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Measure Type	Secondary
Measure Title	Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)
Measure Description	Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
Time Frame	24 Hours
Safety Issue	No

Population Description

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.
Per Protocol-The set of data generated by the subset of subjects who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers exposure to treatment, availability of measurements and absence of major protocol violations.

Reporting Groups

	Description
Panel A	5 mg Rizatriptan
Panel B	10 mg Rizatriptan

Measured Values

	Panel A	Panel B
Number of Participants Analyzed [units: participants]	9	10
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax) [units: Hours] Median ( Full Range )	1.0 ( 0.3 to 2.0 )	1.5 ( 0.3 to 3.0 )

No statistical analysis provided for Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan – Time to Maximum Concentration (Tmax)

5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

No publications provided

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