Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT04153409Other idLAT-MIG-001

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 21 participants (actual)
Sponsor: Lateral Pharma Pty Ltd · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Australia
Start: 24 Sept 2019
Primary completion: 15 Feb 2020
Completion: 10 Apr 2020
First posted: 6 Nov 2019
Last update posted: 28 Apr 2021
Conditions: Acute Migraine

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph 2
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
NCT04153409
24 Sept 2019 to 10 Apr 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LAT8881Drug
PlaceboDrug

Arms2

Experimental
Active
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.
Placebo comparator
Placebo
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Time frame · 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Registry description
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.

Secondary outcomes(3)

Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Time frame · 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Registry description
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Time frame · 0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Registry description
Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms). A larger negative number represents a greater reduction in symptom intensity.
The Percentage of Subjects Achieving "no Headache Pain"
Time frame · 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose
Registry description
Defined as having no migraine headache pain

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (score on a scale)	Spread
Active	0	1.10
Placebo	0.2	1.33

Secondary and other outcome results(3)

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

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

Group	Value (score on a scale)	Spread
Active	-0.3	2.24
Placebo	-0.1	1.05

Secondary outcomeMean· 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)

Group	Value (score on a scale)	Spread
Active	-0.5	2.03
Placebo	-0.1	1.60

Secondary outcomeCount of participants· 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose

The Percentage of Subjects Achieving "no Headache Pain"

Group	Value (Participants)
Active	0
Placebo	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
ActiveSubjects 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. LAT8881: Two 30 mg capsules of LAT8881	0 / 17	0 / 17	3 / 17
PlaceboSubjects 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. Placebo: Two capsules of placebo	0 / 17	0 / 17	3 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 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 International Classification of Headache-3 3. Onset of migraine headache before age 50 4. 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) 5. Minimum 48 hours on average between migraine headache attacks 6. Acute headache medication on ≤ 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 Exclusion Criteria: 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: 1. 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 2. 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 intractable migraine or medication overuse headache within 6 months of screening

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