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

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ClinicalTrials.gov Identifier: NCT00963937
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : August 26, 2011
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE August 24, 2009
Results First Submitted Date  ICMJE July 28, 2011
Results First Posted Date  ICMJE August 26, 2011
Last Update Posted Date August 6, 2018
Study Start Date  ICMJE September 28, 2009
Actual Primary Completion Date December 1, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment [ Time Frame: 120 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
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 ]
Change History Complete list of historical versions of study NCT00963937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    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.
  • Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Pain free was defined as a post-treatment pain intensity score of 1 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 a rescue medication. 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.
  • Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Photophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication.
  • Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as "absent" at each time point in his or her patient diary. Phonophobia was recorded as "present" for all subsequent assessments if a participant took rescue medication.
  • Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as "absent" at each time point in his or her patient diary. Nausea was recorded as "present" for all subsequent assessments if a participant took rescue medication.
  • Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment [ Time Frame: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as "absent" at each time point in his or her patient diary. Vomiting was recorded as "present" for all subsequent assessments if a participant took a rescue medication.
  • Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment [ Time Frame: within 240 minutes post-treatment (Randomization through Final Visit [Week 6]) ]
    Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
  • Proportion of subjects who used rescue medication between the time of dosing to 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of vomiting at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who report pain-relief at 30, 60, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are pain-free at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of photophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of phonophobia at 30, 60, 120, and 240 minutes [ Time Frame: Within 240min post-treatment ]
  • Percentage of subjects who are free of nausea at 30, 60, 120, and 240 minutes post-treatment [ Time Frame: Within 240min post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Sumatriptan 25 mg
    Intervention: Drug: Sumatriptan 25 mg
  • Active Comparator: Sumatriptan 50 mg
    Intervention: Drug: Sumatriptan 50 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
178
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2009)
166
Actual Study Completion Date  ICMJE December 3, 2010
Actual Primary Completion Date December 1, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00963937
Other Study ID Numbers  ICMJE 111035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP