A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
Overview
- Phase
- Phase 3
- Intervention
- Combination Product (sumatriptan succinate / naproxen sodium)
- Conditions
- Migraine Disorders
- Sponsor
- GlaxoSmithKline
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 1 of 2]
Detailed Description
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks. Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit. The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is male or female between 18 and 65 years old.
- •Subject has migraine with or without aura (2004 ICHD-II criteria).
- •Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month.
- •Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response.
- •A female is eligible to enter and participate in this study if she is of:
- •non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- •child-bearing potential, has a negative urine pregnancy test at screen, and agrees to one of the following acceptable measures of contraception:
- •Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 days); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit; or,
- •Female sterilization; or,
- •Sterilization of male partner; or,
Exclusion Criteria
- •Subjects with any of the following criteria may not enroll in the study:
- •Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias.
- •Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
- •Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
- •Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- •Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
- •Subject has a history of congenital heart disease.
- •Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
- •Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
- •Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
Arms & Interventions
Combination Product - Placebo
Combination product (sumatriptan and naproxen sodium) \[Attack 1\] followed by placebo \[Attack 2\]
Intervention: Combination Product (sumatriptan succinate / naproxen sodium)
Combination Product - Placebo
Combination product (sumatriptan and naproxen sodium) \[Attack 1\] followed by placebo \[Attack 2\]
Intervention: Placebo
Placebo - Combination Product
Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\]
Intervention: Combination Product (sumatriptan succinate / naproxen sodium)
Placebo - Combination Product
Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\]
Intervention: Placebo
Outcomes
Primary Outcomes
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
Time Frame: 2 - 24 hours post-dose
Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.
Secondary Outcomes
- Pain-Free Assessment at 2 Hours Post-dose(2 hours post-dose)
- Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose(1/2, 1, 4, and 8 hours post-dose)
- Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose(2, 4 , and 8 hours post-dose)
- Sustained Freedom From Migraine-Associated Sinus Pain(2 - 24 hours post-dose)
- Sustained Freedom From Migraine-Associated Photophobia(2 - 24 hours post-dose)
- Recurrence of Any Migraine Headache Pain(24 hours and 48 hours)
- Sustained Freedom From Migraine-Associated Neck Pain(2 - 24 hours post-dose)
- Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours post-dose)
- Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours)
- Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours post-dose)
- Rescue Medication Used up to 24 Hours Post-dose(Dosing to 24 hours post-dose)
- Sustained Freedom From Migraine(2 - 24 hours post-dose)
- Sustained Freedom From Migraine-Associated Phonophobia(2 - 24 hours post-dose)
- Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours post-dose)
- Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours post-dose)
- Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose(Baseline, 2, 4, and 8 hours post-dose)
- Sustained Freedom From Migraine-Associated Nausea(2 - 24 hours post-dose)
- Sustained Complete Pain/Symptom-Free(2 - 24 hours post-dose)