Acute MigrainePhase 2NCT04153409

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

A Phase 2 study testing LAT8881 in people with Acute Migraine, run by Lateral Pharma Pty Ltd at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Migraine
What is being tested?: LAT8881
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 3 sitesAustralia
Study dates: 24 Sep 2019to 10 Apr 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

Emeritus Research
Camberwell, Victoria, 3124
Paratus Clinical Research, Central Coast
Kanwal, New South Wales, 2259
Paratus Clinical Research, Blacktown
Sydney, New South Wales, 2148

Other trials in Australia

About this study

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.

Read the detailed description

Subjects enrolled in the study will be randomised to receive investigational medicinal product (LAT8881 60 mg or placebo), to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity [Numeric rating scale greater than 4]. Rescue medication should not be taken until at least 2 hours post dose. Subjects will be given a single dose of either active or placebo, to treat one migraine headache.

After treatment of one migraine headache (or a maximum 28 days) the subject will return to the clinic for re-evaluation and crossover to the second treatment. After treatment of one migraine headache in the second treatment period or a maximum of 28 days from commencement of the second treatment period, the subject will return to the clinic for re-evaluation. An End of study visit (telephone) will occur 7 days after the end of the second treatment period.

Conditions: Acute Migraine
Being tested: LAT8881, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAT8881Drug
Two 30 mg capsules of LAT8881
PlaceboDrug
Two capsules of placebo

Study groups in NCT04153409
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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
Measured: 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)
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.
Measured: 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"
Defined as having no migraine headache pain
Measured: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201910 Apr 2020

First posted6 Nov 2019
Study start24 Sep 2019
Primary completion15 Feb 2020
Study completion10 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomised assignment
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04153409
Sponsor's protocol ID: LAT-MIG-001
Status last verified: Apr 2021
First submitted: 4 Nov 2019
Last updated: 28 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Acute Migraine
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Consistency of Response With Rimegepant in Acute Treatment of Migraine
Migraine

All Acute Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
ClinicalTrials.gov ID: NCT04153409
Acronym / sponsor ID: LAT-MIG-001
Conditions: Acute Migraine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Lateral Pharma Pty LtdIndustry (pharma, biotech, devices)
Study start: 24 Sep 2019 (actual)
Primary completion: 15 Feb 2020 (actual)
Study completion: 10 Apr 2020 (actual)
First posted: 6 Nov 2019 (actual)
Results: Posted 30 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomised assignment

Arm	Type	Receives
Active	Experimental	Drug: LAT8881Subjects 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	Placebo comparator	Drug: 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LAT8881Two 30 mg capsules of LAT8881	Drug	Active
PlaceboTwo capsules of placebo	Drug	Placebo

Primary outcome

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
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.

3 secondary outcomes

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
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
The Percentage of Subjects Achieving "no Headache Pain"
Time frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose

Results and safety

Results posted to the registry on 30 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAT8881, Then Placebo	10	8
Placebo, Then LAT8881	11	9

Primary outcome: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Active n = 16	Placebo n = 17
Change from baseline at 0.5 hours	0 (1.10)	0.2 (1.33)
Change from baseline at 1 hour	-0.8 (1.83)	-0.2 (1.68)
Change from baseline at 1.5 hours	-0.9 (2.36)	-0.5 (1.84)
Change from baseline at 2 hours	-1.8 (3.12)	-0.8 (2.63)
Change from baseline at 4 hours	-2.7 (2.96)	-2.2 (3.56)
Change from baseline at 8 hours	-4.6 (2.31)	-3.7 (3.39)
Change from baseline at 24 hours	-5.8 (1.87)	-5.6 (2.8)

Active vs Placebo: Mean Difference (Net): -0.02 (95% CI -1.23 to 1.19), p = 0.9733, Mixed Models Analysis
Active vs Placebo: Mean Difference (Net): -0.42 (95% CI -1.64 to 0.79), p = 0.4942, Mixed Models Analysis
Active vs Placebo: Mean Difference (Net): -0.25 (95% CI -1.46 to 0.97), p = 0.6866, Mixed Models Analysis

Population analysed: Per protocol population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the first dose until the end of study visit, approximately 64 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17
Placebo	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Migraine

RecruitingPhase 3
A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine
Acute Migraine
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
Migraine
Active, not recruitingObservational study
Efficacy of Rimegepant 75 mg for the Acute Treatment of Migraine: a Bayesian Individual Participant Data Meta-analysis Standardized to Defined Target Populations
Migraine
Active, not recruitingObservational study
Consistency of Response With Rimegepant in Acute Treatment of Migraine
Migraine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LAT8881 in people with Acute Migraine, run by Lateral Pharma Pty Ltd at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.