Back to resultsA Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Primary Purpose
Acute Migraine
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
LAT8881
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Migraine
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
Sites / Locations
- Paratus Clinical Research, Central Coast
- Paratus Clinical Research, Blacktown
- Emeritus Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
The Percentage of Subjects Achieving "no Headache Pain"
Defined as having no migraine headache pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04153409
Brief Title
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Official Title
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lateral Pharma Pty Ltd
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomised assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LAT8881
Intervention Description
Two 30 mg capsules of LAT8881
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two capsules of placebo
Primary Outcome Measure Information:
Title
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
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.
Time Frame
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Secondary Outcome Measure Information:
Title
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
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
Time Frame
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Title
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
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.
Time Frame
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Title
The Percentage of Subjects Achieving "no Headache Pain"
Description
Defined as having no migraine headache pain
Time Frame
30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Paratus Clinical Research, Central Coast
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Paratus Clinical Research, Blacktown
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
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