A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine

NCT04153409 | Completed Phase 2 Results FDA Drug

• 1 other identifier: LAT-MIG-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)

  Change in migraine headache pain score, using an 11-point numeric rating scale (NRS), (0 = none, 10 = worst imaginable), Pain is recorded in a subject diary and should reflect the subject's pain at the time of recording. A reduction in NRS score indicates a reduction in pain intensity.

  0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose

Secondary Outcomes (3)

• Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)

  0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose

• Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)

  0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose

• The Percentage of Subjects Achieving "no Headache Pain"

  30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose

Study Arms (2)

Active

EXPERIMENTAL

Subjects will be given two 30 mg capsules of the investigational medicinal product (LAT8881), and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.

Drug: LAT8881

Placebo

PLACEBO COMPARATOR

Subjects will be given two capsules of placebo, and instructed to take both capsules within the first hour of the onset of a migraine of moderate to severe intensity.

Drug: Placebo

Interventions

LAT8881 DRUG

Two 30 mg capsules of LAT8881

Active

Placebo DRUG

Two capsules of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lateral Pharma Pty Ltd: lead

Study Sites (3)

Paratus Clinical Research, Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Paratus Clinical Research, Blacktown

Sydney, New South Wales, 2148, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Results Point of Contact

• Title: Mr David Kenley
• Organization: Lateral Pharma Pty Ltd

dk@lateral-pharma.com

+61400151490

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised assignment

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: September 24, 2019
• Primary Completion: February 15, 2020
• Study Completion: April 10, 2020
• Last Updated: April 28, 2021
• Results First Posted: March 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)