CompletedNCT01001234Updated May 7, 2024Results posted

A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)

A Phase 3 interventional study of rizatriptan and placebo in Migraine, Acute, sponsored by Organon and Co. Completed. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,382
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study summary

This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.

Conditions studied

Migraine, Acute

Browse trials for

Migraine Disorders 1,528

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 1,382 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient weighs at least 20 kg (44 pounds)
Patient has had a history of migraine with or without aura > 6 months with >= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
Patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication
Patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (NSAIDs) or N-acetyl-p-aminophenol (APAP) treatment
The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and

patient assent

For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.

Exclusion criteria

Exclusion Criteria:

Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
Patient has basilar or hemiplegic migraine headaches
Patient has >15 headache-days per month OR has taken medication for acute

headache on more than 10 days per month in any of the 3 months prior to screening

Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any

cancer, or any other significant disease

Patient has a history or clinical evidence of cardiovascular problems or stroke
Patient has either demonstrated hypersensitivity to or experienced a serious

adverse event in response to rizatriptan

Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
Patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
Patient is currently participating or has participated in a study with an

investigational compound or device within 30 days of screening

Patient is legally or mentally incapacitated.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,382 participants (actual)

Study arms

Experimental
Stage 1: rizatriptan
Drug: rizatriptan
Placebo comparator
Stage 1: placebo
Drug: placebo
Experimental
Stage 2: rizatriptan
Drug: rizatriptan
Placebo comparator
Stage 2: placebo
Drug: placebo

Interventions

Drugrizatriptan
For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity). Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.
Also known as: Maxalt, MK-0462
Drugplacebo
For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.
Drugrizatriptan
For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder \[moderate or severe pain 15 minutes after dose\] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.
Also known as: Maxalt, MK-0462
Drugplacebo
For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.

What researchers measure

Primary outcomes

Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.
Time frame: 2 hours post Stage 2 dose

Secondary outcomes

Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.
Time frame: 2 hours post Stage 2 dose
Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.
Time frame: 2 hours post Stage 2 dose
Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.
Time frame: 2 hours post Stage 2 dose

Results

Posted May 8, 2012

Participant flow

Participant flow — Overall Study
Milestone	Placebo/NA	Rizatriptan/NA	Placebo/Rizatriptan	Placebo/Placebo	Rizatriptan/Placebo
Started	492	31	409	410	40
Particpants treated	124	8	400	405	40
Participants not treated	368	23	9	5	0
Completed	87	5	377	385	40
Not completed	405	26	32	25	0
Withdrew: Withdrawal by subject	2	0	3	0	0
Withdrew: Protocol violation	34	3	19	18	0
Withdrew: Lost to follow-up	0	0	1	2	0
Withdrew: Physician decision	1	0	0	0	0
Withdrew: Not treated: adverse event	1	0	0	0	0
Withdrew: Not treated: withdrawal by subject	23	2	2	0	0
Withdrew: Not treated: protocol violation	3	0	0	0	0
Withdrew: Not treated: lost to follow-up	53	4	7	5	0
Withdrew: Not treated: pregnancy	3	0	0	0	0
Withdrew: Not treated: physician decision	37	4	0	0	0
Withdrew: Not treated: lack of qualifying event	248	13	0	0	0

Outcome measures

PrimaryPain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age

Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.

Time frame:: 2 hours post Stage 2 dose
Reported as:: Number · participants

Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
participants	Rizatriptan	Placebo
2-hour pain freedom	87 (25.3 to 36.4)	63 (17.4 to 27.3)
No 2-hour pain freedom	197	223

Statistical analysis

Rizatriptan vs Placebo · Regression, Logistic · p = 0.025 (The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.) · Odds ratio (or): 1.55 · 95% CI 1.06 to 2.26Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.

SecondaryPain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age

Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.

Time frame:: 2 hours post Stage 2 dose
Reported as:: Number · participants

Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age
participants	Rizatriptan	Placebo
2-hour pain relief	167 (52.8 to 64.6)	147 (45.4 to 57.3)
No 2-hour pain relief	117	139

Statistical analysis

Rizatriptan vs Placebo · Regression, Logistic · p = 0.080 (Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.) · Odds ratio (or): 1.35 · 95% CI 0.96 to 1.90This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.

SecondaryPain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age

Time frame:: 2 hours post Stage 2 dose
Reported as:: Number · participants

Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
participants	Rizatriptan	Placebo
2-hour pain freedom	126 (28.3 to 37.9)	94 (20.0 to 28.8)
No 2-hour pain freedom	256	294

Statistical analysis

Rizatriptan vs Placebo · Regression, Logistic · p = 0.010 (This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.) · Odds ratio (or): 1.52 · 95% CI 1.10 to 2.10

SecondaryPain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age

Time frame:: 2 hours post Stage 2 dose
Reported as:: Number · participants

Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age
participants	Rizatriptan	Placebo
2-hour pain relief	220 (52.5 to 62.6)	204 (47.5 to 57.6)
No 2-hour pain relief	162	184

Statistical analysis

Rizatriptan vs Placebo · Regression, Logistic · p = 0.178 (This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.) · Odds ratio (or): 1.22 · 95% CI 0.91 to 1.63

Adverse events

Collected over Up to 14 days post dose. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Rizatriptan	—	0/462 (0%)	0/462 (0%)
Placebo	—	2/515 (0.4%)	0/515 (0%)

Most frequent serious events

Most frequent serious events
Event	Rizatriptan	Placebo
Enterobacter bacteremiaInfections and infestations	0/462	1/515
MigraineNervous system disorders	0/462	1/515

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo/NA	Rizatriptan/NA	Placebo/Rizatriptan	Placebo/Placebo	Rizatriptan/Placebo	Total
Mean	12.7 ± 2.9	13.4 ± 2.1	13.0 ± 2.9	13.1 ± 2.9	13.1 ± 3.4	13.0 ± 2.9

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo/NA	Rizatriptan/NA	Placebo/Rizatriptan	Placebo/Placebo	Rizatriptan/Placebo	Total
Female	61	4	227	238	20	550
Male	63	4	173	167	20	427

Study locations

No study locations are listed for this record.

References and documents

Publications

Ho TW, Pearlman E, Lewis D, Hamalainen M, Connor K, Michelson D, Zhang Y, Assaid C, Mozley LH, Strickler N, Bachman R, Mahoney E, Lines C, Hewitt DJ; Rizatriptan Protocol 082 Pediatric Migraine Study Group. Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012 Jul;32(10):750-65. doi: 10.1177/0333102412451358. Epub 2012 Jun 18. PubMed 22711898 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01001234
Lead sponsor: Organon and Co
Responsible party: Sponsor
First posted: Oct 26, 2009
Start date: Nov 30, 2009
Primary completion: Apr 21, 2011
Completion: Apr 21, 2011
Results posted: May 8, 2012
Last update: May 7, 2024

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)

Study summary

Conditions studied

Browse trials for

In context

Migraine Disorders

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria