A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)

NCT01004263 | Completed Phase 3 Results

• 2 other identifiers: 0462-0862009_680
• Study Type: interventional
• Target: 674
• Locations: 0 countries
• Sites: N/A

Brief Summary

To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.

Conditions

Acute Migraine With or Without Aura in Adolescents

Keywords

acute migraine with or without aura in adolescents

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.

  Up to 24 hours post dose

• Number of Participants With AEs Within 14 Days Post Any Dose

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.

  Up to 14 days post dose

• Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.

  Up to 24 hours post dose

• Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose

  An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.

  Up to 14 days post dose

Secondary Outcomes (1)

• Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose

  2 hours post dose

Study Arms (1)

Rizatriptan

EXPERIMENTAL

Rizatriptan benzoate

Drug: rizatriptan benzoate

Interventions

rizatriptan benzoate DRUG

Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack

Also known as: MK-0462, Maxalt

Rizatriptan

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient is between 12 and 17 years of age inclusive at screening Visit 1
• Patient weighs at least 20 kg (44 pounds)
• Patient has had a history of unilateral or bilateral migraine headache with or without aura \>6 months with ≥1 to ≤8 mild, 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
• 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

You may not qualify if:

• 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 cardiovascular problems or stroke
• Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
• Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription)
• 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, 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Hewitt DJ, Pearlman E, Hamalainen M, Lewis D, Connor KM, Michelson D, Ceesay P, Assaid C, Bachman R, Harper Mozley L, Dupre N, Strickler N, Mahoney E, Lines C, Ho TW. Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. Headache. 2013 Jan;53(1):104-117. doi: 10.1111/j.1526-4610.2012.02285.x. Epub 2012 Oct 18.

  PMID: 23078588 DERIVED

MeSH Terms

Interventions

rizatriptan

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: December 1, 2009
• Primary Completion: April 18, 2011
• Study Completion: April 18, 2011
• Last Updated: April 22, 2024
• Results First Posted: May 4, 2012

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share