Phase 2
N=21
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Acute Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04153409 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) — 0; 0.2; -0.8; -0.2 score on a scale — p=0.9733
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LAT8881 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lateral Pharma Pty Ltd
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes) |
0; 0.2; -0.8; -0.2; -0.9; -0.5 | 0.9733 |
| SECONDARY Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes) |
-0.3; -0.1; -0.9; -0.6; -1.0; -1.0 | — |
| SECONDARY Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes) |
-0.5; -0.1; -1.1; -0.6; -1.2; -1.2 | — |
| SECONDARY The Percentage of Subjects Achieving "no Headache Pain" |
0; 0; 0; 0; 0; 0 | — |
Summary
This is a randomised, placebo controlled, double blind, crossover proof of concept study to investigate the efficacy and safety of oral LAT8881 in acute migraine, with or without aura.
Eligibility Criteria
Inclusion Criteria
- Males or females aged 18 to 75 years at the time of consent
- Diagnosis of episodic migraine headache at least 12 months ago with or without aura as defined in International Classification of Headache-3
- Onset of migraine headache before age 50
- Medical history of 2 - 8 migraine headache attacks per month for the previous 12 months; ≥ 75% of attacks progress to moderate or severe pain within 2 hours (ie, rapidly-escalating)
- Minimum 48 hours on average between migraine headache attacks
- Acute headache medication on ≤ 14 days/month in the 3 months prior to screening
- 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
Exclusion Criteria
- Unable to distinguish migraine from other primary headache conditions
- 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)
- History of aura lasting more than 60 minutes
- History of vomiting within 2 hours of onset of a migraine headache in more than 25% of migraine headaches
- Medication overuse headache, defined as:
- 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
- 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
- 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
- Hospital admission for status intractable migraine or medication overuse headache within 6 months of screening
Data sourced from ClinicalTrials.gov (NCT04153409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.