Trial Outcomes & Findings for Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1) (NCT NCT00604812)

Last Updated: 2024-04-19

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

24 Hours

Results posted on

2024-04-19

Participant Flow

Panel C was added to the study by amendment after enrollment of Panels A and B were completed.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	9	3	10	3	5	1
Overall Study COMPLETED	9	3	10	3	5	1
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panel A n=12 Participants Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)	Panel B n=13 Participants Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)	Panel C n=6 Participants Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)	Total n=31 Participants Total of all reporting groups
Age, Customized Ages 6 to <12	11 years 1.44 • n=93 Participants	2 years 2.14 • n=4 Participants	0 years n=27 Participants	13 years n=483 Participants
Age, Customized Ages 12 to 17	1 years n=93 Participants	11 years n=4 Participants	6 years n=27 Participants	18 years n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	8 Participants n=4 Participants	0 Participants n=27 Participants	13 Participants n=483 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants	18 Participants n=483 Participants
Weight 20-39 kg	12 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants	13 participants n=483 Participants
Weight ≥ 40 kg	0 participants n=93 Participants	13 participants n=4 Participants	5 participants n=27 Participants	18 participants n=483 Participants

PRIMARY outcome

Timeframe: 24 Hours

Population: All Subjects as Treated- All subjects who received at least one dose of the investigational drug was used for assessments of safety and tolerability.

Outcome measures

Outcome measures
Measure	Rizatriptan 5 mg n=10 Participants Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=14 Participants Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=7 Participants Combined Placebo groups from panels A, B, and C.
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs Serious Adverse Events	0 Participants	0 Participants	0 Participants
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs Non-Serious Adverse Events	3 Participants	7 Participants	3 Participants
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs No Adverse Events Reported	7 Participants	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 Hours

Population: 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.

Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot

Outcome measures

Outcome measures
Measure	Rizatriptan 5 mg n=9 Participants Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=10 Participants Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=5 Participants Combined Placebo groups from panels A, B, and C.
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))	59.4 ng hr/mL Standard Deviation 11.5	84.0 ng hr/mL Standard Deviation 19.8	67.93 ng hr/mL Standard Deviation 25.17

SECONDARY outcome

Timeframe: 24 Hours

Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved

Outcome measures

Outcome measures
Measure	Rizatriptan 5 mg n=9 Participants Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=10 Participants Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=5 Participants Combined Placebo groups from panels A, B, and C.
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)	24.6 ng/mL Standard Deviation 7.2	25.0 ng/mL Standard Deviation 8.1	18.4 ng/mL Standard Deviation 5.5

SECONDARY outcome

Timeframe: 24 Hours

Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration

Outcome measures

Outcome measures
Measure	Rizatriptan 5 mg n=9 Participants Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=10 Participants Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=5 Participants Combined Placebo groups from panels A, B, and C.
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)	1.0 Hours Interval 0.3 to 2.0	1.5 Hours Interval 0.3 to 3.0	1.3 Hours Interval 0.7 to 1.7

SECONDARY outcome

Timeframe: 24 Hours

Preliminary pharmacokinetics data; Apparent half-life (t½)

Outcome measures

Outcome measures
Measure	Rizatriptan 5 mg n=9 Participants Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=10 Participants Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=5 Participants Combined Placebo groups from panels A, B, and C.
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)	1.3 Hours Standard Deviation 0.1	1.6 Hours Standard Deviation 0.2	1.6 Hours Standard Deviation 0.4

Adverse Events

Rizatriptan 5 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rizatriptan 10 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rizatriptan 5 mg n=10 participants at risk Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.	Rizatriptan 10 mg n=14 participants at risk Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.	Placebo n=7 participants at risk Combined Placebo groups from panels A, B, and C.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1	14.3% 2/14 • Number of events 2	0.00% 0/7
Injury, poisoning and procedural complications Bruising of arm	10.0% 1/10 • Number of events 1	7.1% 1/14 • Number of events 1	0.00% 0/7
Nervous system disorders Syncope	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7
Nervous system disorders Hypersomnia	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7
Ear and labyrinth disorders Earache	10.0% 1/10 • Number of events 1	0.00% 0/14	0.00% 0/7
Eye disorders Visual disturbance	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7
General disorders Injection site pain	0.00% 0/10	0.00% 0/14	14.3% 1/7 • Number of events 1
General disorders Tiredenss	0.00% 0/10	0.00% 0/14	14.3% 1/7 • Number of events 1
Infections and infestations Cold	10.0% 1/10 • Number of events 1	0.00% 0/14	0.00% 0/7
Injury, poisoning and procedural complications Scratch	0.00% 0/10	0.00% 0/14	14.3% 1/7 • Number of events 1
Musculoskeletal and connective tissue disorders Painful left arm	0.00% 0/10	0.00% 0/14	14.3% 1/7 • Number of events 1
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/10	0.00% 0/14	14.3% 1/7 • Number of events 1
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7
Vascular disorders Elevation in blood pressure	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7
Nervous system disorders Somnolence	0.00% 0/10	7.1% 1/14 • Number of events 1	0.00% 0/7

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER