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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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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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	4%

Reporting Groups

	Description
Panel A	5 mg Rizatriptan
Panel B	10 mg Rizatriptan
Placebo	Combined Placebo groups from panels A & B

Other Adverse Events

	Panel A	Panel B	Placebo
Total, other (not including serious) adverse events
# participants affected	3	5	3
Ear and labyrinth disorders
Earache ^† # participants affected / at risk # events	1/9 (11.11%) 1	0/10 (0.00%) 0	0/6 (0.00%) 0
Eye disorders
Visual disturbance ^† # participants affected / at risk # events	0/9 (0.00%) 0	1/10 (10.00%) 1	0/6 (0.00%) 0
General disorders
Injection site pain ^† # participants affected / at risk # events	0/9 (0.00%) 0	0/10 (0.00%) 0	1/6 (16.67%) 1
Tiredenss ^† # participants affected / at risk # events	0/9 (0.00%) 0	0/10 (0.00%) 0	1/6 (16.67%) 1
Infections and infestations
Cold ^† # participants affected / at risk # events	1/9 (11.11%) 1	0/10 (0.00%) 0	0/6 (0.00%) 0
Injury, poisoning and procedural complications
Bruising of arm ^† # participants affected / at risk # events	1/9 (11.11%) 1	1/10 (10.00%) 1	0/6 (0.00%) 0
Scratch ^† # participants affected / at risk # events	0/9 (0.00%) 0	0/10 (0.00%) 0	1/6 (16.67%) 1
Musculoskeletal and connective tissue disorders
Painful left arm ^† # participants affected / at risk # events	0/9 (0.00%) 0	0/10 (0.00%) 0	1/6 (16.67%) 1
Shoulder pain ^† # participants affected / at risk # events	0/9 (0.00%) 0	0/10 (0.00%) 0	1/6 (16.67%) 1
Nervous system disorders
Headache ^† # participants affected / at risk # events	1/9 (11.11%) 1	2/10 (20.00%) 2	0/6 (0.00%) 0
Syncope ^† # participants affected / at risk # events	0/9 (0.00%) 0	1/10 (10.00%) 1	0/6 (0.00%) 0
Hypersomnia ^† # participants affected / at risk # events	0/9 (0.00%) 0	1/10 (10.00%) 1	0/6 (0.00%) 0
Respiratory, thoracic and mediastinal disorders
Sore throat ^† # participants affected / at risk # events	0/9 (0.00%) 0	1/10 (10.00%) 1	0/6 (0.00%) 0

^†	Indicates events were collected by systematic assessment.

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