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

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ClinicalTrials.gov Identifier: NCT04153409
Recruitment Status : Completed
First Posted : November 6, 2019
Results First Posted : March 30, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Lateral Pharma Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Acute Migraine Drug: LAT8881 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Actual Study Start Date : September 24, 2019
Actual Primary Completion Date : February 15, 2020
Actual Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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.
Drug: LAT8881
Two 30 mg capsules of LAT8881

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.
Drug: Placebo
Two capsules of placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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.

  3. The Percentage of Subjects Achieving "no Headache Pain" [ Time Frame: 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose ]
    Defined as having no migraine headache pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153409


Locations
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Australia, New South Wales
Paratus Clinical Research, Central Coast
Kanwal, New South Wales, Australia, 2259
Paratus Clinical Research, Blacktown
Sydney, New South Wales, Australia, 2148
Australia, Victoria
Emeritus Research
Camberwell, Victoria, Australia, 3124
Sponsors and Collaborators
Lateral Pharma Pty Ltd
  Study Documents (Full-Text)

Documents provided by Lateral Pharma Pty Ltd:
Study Protocol  [PDF] July 25, 2019
Statistical Analysis Plan  [PDF] February 27, 2020

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Responsible Party: Lateral Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT04153409    
Other Study ID Numbers: LAT-MIG-001
First Posted: November 6, 2019    Key Record Dates
Results First Posted: March 30, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases