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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04153409




Registration number
NCT04153409
Ethics application status
Date submitted
4/11/2019
Date registered
6/11/2019

Titles & IDs
Public title
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Scientific title
A Proof of Concept Study of the Efficacy and Safety of Oral LAT8881 in Acute Migraine
Secondary ID [1] 0 0
LAT-MIG-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LAT8881
Treatment: Drugs - Placebo

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.


Treatment: Drugs: LAT8881
Two 30 mg capsules of LAT8881

Treatment: Drugs: Placebo
Two capsules of placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Migraine Headache Pain Score From Time of Dosing (0 Minutes)
Timepoint [1] 0 0
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Secondary outcome [1] 0 0
Change in Migraine-associated Symptoms of Nausea, Photophobia and Phonophobia From Time of Dosing (0 Minutes)
Timepoint [1] 0 0
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Secondary outcome [2] 0 0
Change in Each Subject's Most Troublesome Symptom From Time of Dosing (0 Minutes)
Timepoint [2] 0 0
0 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours and 24 hours post dose
Secondary outcome [3] 0 0
The Percentage of Subjects Achieving "no Headache Pain"
Timepoint [3] 0 0
30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 8 hours post-dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/04/2020
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research, Central Coast - Kanwal
Recruitment hospital [2] 0 0
Paratus Clinical Research, Blacktown - Sydney
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2148 - Sydney
Recruitment postcode(s) [3] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lateral Pharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04153409