Migraine DisordersPhase 3NCT00963937
Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
A Phase 3 study testing Sumatriptan 25 mg and Sumatriptan 50 mg in people with Migraine Disorders, run by GlaxoSmithKline at 16 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Sumatriptan 25 mg and Sumatriptan 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 16 sitesJapan
- Study dates
- 28 Sep 2009to 3 Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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%)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
GSK Investigational Site
Aichi, 450-0002
GSK Investigational Site
Aichi, 467-8602
GSK Investigational Site
Hokkaido, 060-0004
GSK Investigational Site
Hokkaido, 060-8570
GSK Investigational Site
Hyōgo, 658-0064
GSK Investigational Site
Hyōgo, 663-8204
GSK Investigational Site
Kagoshima, 892-0844
GSK Investigational Site
Kanagawa, 215-0021
GSK Investigational Site
Kanagawa, 221-0835
GSK Investigational Site
Kanagawa, 252-0375
GSK Investigational Site
Kyoto, 600-8811
GSK Investigational Site
Osaka, 560-0012
GSK Investigational Site
Saitama, 336-8522
GSK Investigational Site
Tokyo, 101-0021
GSK Investigational Site
Tokyo, 105-7103
GSK Investigational Site
Tokyo, 132-0024
About this 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
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
- Being tested
- Sumatriptan 25 mg, Sumatriptan 50 mg, Placebo
- Keywords
- adolescent, sumatriptan, children, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan 25 mgDrug
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 mgDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Sumatriptan 25 mg | Active comparator | Not described Receives: Drug: Sumatriptan 25 mg |
| Sumatriptan 50 mg | Active comparator | Not described Receives: Drug: Sumatriptan 50 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment
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.
Measured: 30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment
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).
Measured: within 240 minutes post-treatment (Randomization through Final Visit [Week 6])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study start28 Sep 2009
- Primary completion1 Dec 2010
- Study completion3 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963937
- Sponsor's protocol ID
- 111035
- Status last verified
- Jun 2018
- First submitted
- 20 Aug 2009
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00963937
- Acronym / sponsor ID
- 111035
- Conditions
- Migraine Disorders
- Keywords
- adolescent, sumatriptan, children, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2009
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 3 Dec 2010 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Posted 26 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan 25 mg | Active comparator | Drug: Sumatriptan 25 mg |
| Sumatriptan 50 mg | Active comparator | Drug: Sumatriptan 50 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumatriptan 25 mgOne 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 25 mg |
| Sumatriptan 50 mgTwo 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 | Sumatriptan 50 mg |
| PlaceboTwo 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. | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
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])
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])
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])
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])
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])
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])
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])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sumatriptan 25 mg and Sumatriptan 50 mg in people with Migraine Disorders, run by GlaxoSmithKline at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment (time frame: 120 minutes post-treatment (Randomization through Final Visit [Week 6])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.