Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents

NCT00963937 | Completed Phase 3 Results

• 1 other identifier: 111035
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Migraine Disorders

Keywords

adolescent; sumatriptan; children; migraine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment

  Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.

  120 minutes post-treatment (Randomization through Final Visit [Week 6])

Secondary Outcomes (7)

• Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment

  30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

• Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment

  30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

• Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment

  30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

• Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment

  30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

• Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment

  30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])

Study Arms (3)

Sumatriptan 25 mg

ACTIVE COMPARATOR

Drug: Sumatriptan 25 mg

Sumatriptan 50 mg

ACTIVE COMPARATOR

Drug: Sumatriptan 50 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sumatriptan 25 mg DRUG

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 25 mg

Sumatriptan 50 mg DRUG

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.

Sumatriptan 50 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Aichi, 450-0002, Japan

Location

GSK Investigational Site

Aichi, 467-8602, Japan

Location

GSK Investigational Site

Hokkaido, 060-0004, Japan

Location

GSK Investigational Site

Hokkaido, 060-8570, Japan

Location

GSK Investigational Site

Hyōgo, 658-0064, Japan

Location

GSK Investigational Site

Hyōgo, 663-8204, Japan

Location

GSK Investigational Site

Kagoshima, 892-0844, Japan

Location

GSK Investigational Site

Kanagawa, 215-0021, Japan

Location

GSK Investigational Site

Kanagawa, 221-0835, Japan

Location

GSK Investigational Site

Kanagawa, 252-0375, Japan

Location

GSK Investigational Site

Kyoto, 600-8811, Japan

Location

GSK Investigational Site

Osaka, 560-0012, Japan

Location

GSK Investigational Site

Saitama, 336-8522, Japan

Location

GSK Investigational Site

Tokyo, 101-0021, Japan

Location

GSK Investigational Site

Tokyo, 105-7103, Japan

Location

GSK Investigational Site

Tokyo, 132-0024, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 24, 2009
• Study Start: September 28, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 3, 2010
• Last Updated: August 6, 2018
• Results First Posted: August 26, 2011

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (16)