Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00963937 | Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents | PHASE3 | COMPLETED | 178 | — | — | Sep 28, 2009 | Dec 3, 2010 | Aug 6, 2018 | 16 | Japan |
| NCT00843024 | Migraine Study in Adolescent Patients | PHASE3 | COMPLETED | 589 | — | — | Dec 1, 2008 | Jun 1, 2010 | Jan 18, 2017 | 79 | United States |
| NCT00356603 | Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan | PHASE3 | COMPLETED | 75 | — | — | Jun 20, 2006 | Aug 7, 2006 | Sep 4, 2018 | 4 | Japan |
| NCT00329459 | Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea | PHASE3 | COMPLETED | 320 | — | — | May 1, 2006 | Nov 1, 2006 | Oct 24, 2016 | 34 | United States |
| NCT00240617 | Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks | PHASE3 | COMPLETED | 623 | — | — | Oct 1, 2005 | Jun 1, 2006 | Oct 26, 2016 | 52 | United States |
| NCT00240630 | Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks | PHASE3 | COMPLETED | 646 | — | — | Oct 1, 2005 | Jun 1, 2006 | Apr 16, 2015 | 50 | United States |
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.
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
| Arm | Type | Description |
|---|---|---|
| Sumatriptan 25 mg | ACTIVE_COMPARATOR | - |
| Sumatriptan 50 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Sumatriptan and Naproxen 1 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 10mg/60mg |
| Sumatriptan and Naproxen 2 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 30mg/180mg |
| Sumatriptan and Naproxen 3 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 85mg/500mg |
| Sumatriptan | EXPERIMENTAL | Sumatriptan |
| arm 1 | EXPERIMENTAL | Treximet (sumatriptan/naproxen sodium) |
| arm 2 | PLACEBO_COMPARATOR | placebo to match |
| Name | Type | Description |
|---|---|---|
| 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 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. |
| 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. |
| Sumatriptan and Naproxen Sodium | DRUG | Sumatriptan succinate and naproxen sodium |
| Sumatriptan Succinate | DRUG | Sumatriptan Succinate |
| sumatriptan succinate/naproxen sodium | DRUG | - |
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. * Subje...