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

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT01004263

Purpose

To provide long term safety data for Rizatriptan in children and adolescents.

Condition	Intervention	Phase
Acute Migraine With or Without Aura in Adolescents	Drug: rizatriptan benzoate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate Potassium benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Percentage of patients with adverse events [ Time Frame: Up to 1 year exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of rizatriptan, measured by proportion of patients experiencing pain freedom, defined as a reduction of a mild, moderate or severe headache to no pain, at 2 hours [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]

Enrollment:	674
Study Start Date:	December 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Rizatriptan benzoate	Drug: rizatriptan benzoate Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 migraine 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

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, 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004263

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01004263 History of Changes
Other Study ID Numbers:	MK-0462-086, 2009_680
Study First Received:	October 28, 2009
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

acute migraine with or without aura in adolescents

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Benzoates
Rizatriptan
Antifungal Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012