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A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
This study is currently recruiting participants.
Verified by GlaxoSmithKline, February 2010
First Received: August 20, 2009   Last Updated: February 4, 2010   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00963937
  Purpose

The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.


Condition Intervention Phase
Migraine
Drug: Sumatriptan 50 mg
Drug: Sumatriptan 25 mg
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of subjects who report pain-relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects who report pain-relief at 30, 60, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects who are pain-free at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects who are free of photophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects who are free of phonophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects who are free of nausea at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects who are free of vomiting at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]
  • Proportion of subjects who used rescue medication between the time of dosing to 240 minutes [ Time Frame: Within 240min post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 166
Study Start Date: September 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sumatriptan 25 mg: Active Comparator Drug: Sumatriptan 25 mg
One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
Sumatriptan 50 mg: Active Comparator Drug: Sumatriptan 50 mg
Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.
Placebo: Placebo Comparator Drug: Placebo
Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is >10 years of age and <17 years of age at the informed consent and the Randomization Visit.
  • Subject has migraine with or without aura (ICHD-II criteria, 1.1 or 1.2.1). A minimum of a six month history of migraine prior to entry into the study is required.
  • Subject has a history of at least two, but no more than eight, attacks per month for the two months prior to entry into the study.
  • All migraine attacks associated with 3 or more pain on a 5-grade scale should last a minimum of three hours for the two months prior to entry into the study.
  • Subject has shown nonresponse to at least one NSAIDs or acetaminophen for the two months prior to entry into the study.
  • Subject is able to distinguish migraine from other headaches (e.g., tension-type headache).
  • Subject is able to read, comprehend, and complete subject diaries.
  • Males or female subjects. Female subjects are eligible for participation in the study if they are one of the following
  • Females of non-childbearing potential (i.e., physiologically incapable of becoming pregnant or have undergone female sterilization)
  • Females of childbearing potential, and who have a negative pregnancy test at the Screening Visit, and agree to use one of the following GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy:
  • Abstinence
  • Oral Contraceptive, either combined or progestogen alone
  • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject)
  • Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
  • Subject's parent or legal guardian is willing and able to provide informed consent prior to subject entry into the study.
  • Subject is willing and able to provide informed assent prior to entry into the study.
  • Subjects considered for enrolment must have a QTc (either QTc B (Bazett's correction) or QTc F (Fridericia's correction)) <450msec at the Screening Visit, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec).

Note: For the purposes of these criteria, QTc B is defined as (QT interval msec) / (square root of RR interval seconds); and QTc F is defined as (QT interval msec) / (cube root of RR interval seconds).)

  • Liver function test at the Screening Visit: AST and ALT <2xULN; alkaline phosphatase and total bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

Exclusion Criteria:

  • Subject is < 30 kg.
  • Subject has 15 or more headache days per month in total (migraine, probable migraine, or tension-type). Subject has retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), hemiplegic (ICHD-II 1.2.4 or 1.2.5), or Ophthalmoplegic migraine (ICHD-II 13.17). Subject has secondary headaches.
  • Subject has a history of cerebrovascular disease or ischemic cerebrovascular disease.
  • Subject has a history of myocardial infarction.
  • Subject has uncontrolled hypertension.
  • Subject has symptoms or signs of ischemic cardiac syndromes.
  • Subject has variant angina.
  • Subject has evidence of a peripheral vascular syndrome.
  • Subject has evidence or history of epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control.
  • Subject has a history of impaired hepatic or renal function that, in the investigator (or subinvestigator)'s opinion, contraindicates participation in this study. Subject has unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice). Subject has cirrhosis. Subject has known biliary abnormalities (with the exception of Gilberts's syndrome or asymptomatic gallstones).
  • Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan (including all sumatriptan preparations) or sulfonamide compounds.
  • Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis.
  • Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI) anytime within the two weeks prior to entry into the study.
  • Subject has evidence of psychotropic, alcohol, or substance abuse within the last year.
  • Subject has participated in any investigational drug trial within the previous 3 months or plans to participate in another study at any time during this study.
  • Subject has any concurrent medical or psychiatric condition which, in the investigator (or subinvestigator)'s judgment, contraindicates participation in this clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963937

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Japan
GSK Investigational Site Not yet recruiting
Hokkaido, Japan, 060-8570
Principal Investigator: Atsuko Nihira            
GSK Investigational Site Recruiting
Hyogo, Japan, 658-0064
Principal Investigator: Shigekazu Kitamura            
GSK Investigational Site Recruiting
Tokyo, Japan, 105-7103
Principal Investigator: Yoshitaka Watanabe            
GSK Investigational Site Recruiting
Kyoto, Japan, 600-8811
Principal Investigator: Yoshihisa Tatsuoka            
GSK Investigational Site Recruiting
Tokyo, Japan, 132-0024
Principal Investigator: Shigeyuki Murakami            
GSK Investigational Site Recruiting
Aichi, Japan, 450-0002
Principal Investigator: Jun Teramoto            
GSK Investigational Site Not yet recruiting
Kanagawa, Japan, 221-0835
Principal Investigator: Hisaka Igarashi            
GSK Investigational Site Not yet recruiting
Aichi, Japan, 467-8602
Principal Investigator: Naoki Ando            
GSK Investigational Site Recruiting
Hyogo, Japan, 663-8204
Principal Investigator: Michio Yamaguchi            
GSK Investigational Site Recruiting
Hokkaido, Japan, 060-0004
Principal Investigator: Kouichi Kitami            
GSK Investigational Site Recruiting
Kagoshima, Japan, 892-0844
Principal Investigator: Shigeya Tanaka            
GSK Investigational Site Not yet recruiting
Kanagawa, Japan, 215-0021
Principal Investigator: Fumihiko Sakai            
GSK Investigational Site Not yet recruiting
Saitama, Japan, 336-8522
Principal Investigator: Kiyoshi Araki            
GSK Investigational Site Not yet recruiting
Tokyo, Japan, 101-0021
Principal Investigator: Kiyoshi Owada            
GSK Investigational Site Recruiting
Osaka, Japan, 560-0012
Principal Investigator: Yasushi Takase            
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111035
Study First Received: August 20, 2009
Last Updated: February 4, 2010
ClinicalTrials.gov Identifier: NCT00963937     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
sumatriptan
children
adolescent
migraine

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions
Headache Disorders
Sumatriptan
Serotonin Agents
Migraine Disorders
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on February 08, 2010