ACTRN12619001369112
Completed
Phase 2
A proof of concept study of the efficacy and safety of oral LAT8881 in acute migraine
ateral Pharma Pty Ltd0 sites21 target enrollmentOctober 8, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ateral Pharma Pty Ltd
- Enrollment
- 21
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet the following criteria to be entered into the study:
- •1\.Males or females aged 18 to 75 years at the time of consent
- •2\.Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in ICHD\-3\-beta2
- •3\.Onset of migraine headache before age 50
- •4\.Medical history of 2 – 8 migraine headache attacks per month for the previous 12 months; with at least 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly\-escalating)
- •5\.Minimum 48 hours on average between migraine headache attacks
- •6\.Acute headache medication on less than 14 days/month in the 3 months prior to screening
- •7\.Willing and able to comply with all study procedures including completion of a headache diary and a migraine diary on the day of a migraine headache
- •8\. Female subjects must be:
- •a)of non\-child\-bearing potential \[surgically sterilised or postmenopausal (12 months with no menses without alternative medical cause)] OR
Exclusion Criteria
- •Subjects who meet any of the following criteria will be excluded from the study:
- •1\.Unable to distinguish migraine from other primary headache conditions
- •2\.Average of 15 or more headache (migraine or nonmigraine) days per month or history of more than 25% of headaches occurring at time of wakening (wake up headaches)
- •3\.History of aura lasting more than 60 minutes
- •4\.History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
- •5\.Medication overuse headache, defined as:
- •a.use of opioids, triptans or ergot alkaloids or any combination of these medications for treatment of headaches 10 or more days per month during the 90 days prior to screening OR
- •b.Non\-steroidal anti\-inflammatory drugs (NSAIDs) or simple analgesics for treatment of headaches on more than 14 days per month during the 90 days prior to screening
- •6\.Recent (3 years) history of frequent or chronic hemiplegic/ basilar migraine, tension headache, retinal migraine, ophthalmoplegic migraine as per ICHD classification, or treatment resistant atypical migraine
- •7\.Hospital admission for status migrainosis or medication overuse headache within 6 months of screening
Outcomes
Primary Outcomes
Not specified
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