Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

This study has been completed.

Study NCT00604812 Information provided by Merck

First Received on October 17, 2007. Last Updated on September 16, 2011 History of Changes

Results First Received: June 3, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Migraine Disorders
Interventions:	Drug: rizatriptan benzoate (5 mg) Drug: rizatriptan benzoate (10 mg) Drug: Rizatriptan 5 mg Placebo Drug: Rizatriptan 10 mg Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Panel C was added to the study by amendment after enrollment of Panels A and B were completed.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Panel A Rizatriptan	Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.
Panel A Placebo	Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 20-39 kg were allocated to Panel A.
Panel B Rizatriptan	Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.
Panel B Placebo	Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1. Subjects weighing 40 kg and above were allocated to Panel B.
Panel C Rizatriptan	Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.
Panel C Placebo	Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose. Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group.

Participant Flow: Overall Study

	Panel A Rizatriptan	Panel A Placebo	Panel B Rizatriptan	Panel B Placebo	Panel C Rizatriptan	Panel C Placebo
STARTED	9	3	10	3	5	1
COMPLETED	9	3	10	3	5	1
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Hide 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)
Panel C	Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)

Baseline Measures

	Panel A	Panel B	Panel C	Total
Number of Participants [units: participants]	12	13	6	31
Age, Customized [units: years]
Ages 6 to <12	11	2	0	13
Ages 12 to 17	1	11	6	18
Gender [units: participants]
Female	5	8	0	13
Male	7	5	6	18
Weight [units: participants]
20-39 kg	12	0	1	13
≥ 40 kg	0	13	5	18

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00604812 History of Changes
Other Study ID Numbers:	MK-0462-083, 2007_601
Study First Received:	October 17, 2007
Results First Received:	June 3, 2009
Last Updated:	September 16, 2011
Health Authority:	United States: Food and Drug Administration