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Trial registered on ANZCTR


Registration number
ACTRN12619001369112
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
8/10/2019
Date last updated
6/05/2021
Date data sharing statement initially provided
8/10/2019
Date results provided
6/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the effect of oral LAT8881 on acute migraine headache
Scientific title
A proof of concept study of the efficacy and safety of oral LAT8881 in acute migraine
Secondary ID [1] 299350 0
None
Universal Trial Number (UTN)
U1111-1240-6816
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Migraine With or Without Aura 314500 0
Condition category
Condition code
Neurological 312845 312845 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a blinded, crossover study. There are two treatment arms: active and placebo, and two treatment periods. Patients are given paper diaries to record daily details of headaches and migraine headaches, and to capture details of other medications. Patients are only given a single dose of active IMP to treat one migraine, and a single dose of placebo to treat one migraine. Patients will only treat two migraines in total across the two treatment periods.
Patients will be randomly assigned to receive either receive active or placebo in their first treatment period, and after a 48 hour washout, will be crossed over to receive the alternative treatment for treatment period 2. The patients are not supervised during dosing, but are sent home from clinic at the start of each treatment period with the active or placebo, and instructions from the clinic staff about the timing of the dosing, and how to complete their diaries.
The active treatment is a single dose of two 30 mg capsules of LAT8881 which patients are to take at the onset (within one hour from the onset of pain) of one migraine headache of moderate to severe intensity.
Total single dose of IMP: 60 mg LAT8881
Intervention code [1] 315618 0
Treatment: Drugs
Comparator / control treatment
Two capsules of matching placebo to be taken at the onset (within one hour from the onset of pain) of a migraine headache of moderate to severe intensity. The placebo capsules match the active capsules, but instead of LAT8881, they contain additional mannitol.
Control group
Placebo

Outcomes
Primary outcome [1] 321453 0
To evaluate the effect of oral LAT8881 on migraine headache compared with placebo, when assessed by the headache severity on an 11-point Numeric Rating Scale (NRS).
Timepoint [1] 321453 0
Change in migraine headache pain score, using an 11-point NRS, (0 = none, 10 = worst imaginable), from the time of dosing (t = 0 min) to 0.5, 1.0, 1.5, 2, 4, 8 and 24-hours post dose.
Secondary outcome [1] 375003 0
To evaluate the effect of oral LAT8881 on migraine associated symptoms compared with placebo, when assessed by the change in symptoms based on a 11 point Likert scale.
Timepoint [1] 375003 0
Composite outcome of the change in migraine-associated symptoms of nausea, photophobia and phonophobia. Symptoms are assessed on an 11- point Likert scale (0 = no symptoms, 10 = severe symptoms), at time of dosing and at 0.5, 1.0, 1.5, 2, 4, 8 and 24 hours post dose.
Secondary outcome [2] 375004 0
To investigate the percentage of subjects achieving “no headache pain” following treatment with oral LAT8881 for a migraine headache compared with placebo at any timepoint to 8 hours post dose, with no use of rescue medication. Absence of pain will be defined as a pain NRS score of 0 or 1.
Timepoint [2] 375004 0
The percentage of subjects achieving “no headache pain” at 0.5, 1.0, 1.5, 2, 4
and 8 hours post dose.
Secondary outcome [3] 375005 0
To evaluate the safety and tolerability of single doses of oral LAT8881 in subjects with migraine headache as measured by physical examination and vital signs, clinical laboratory tests, adverse events, use of concomitant medication
Timepoint [3] 375005 0
1. Changes in physical examinations and vital signs
2. Changes in clinical laboratory tests
3. Percentage of treatment emergent adverse events (TEAEs), including serious
adverse events (SAEs), and suspected unexpected serious adverse reactions
(SUSARs)
4. Changes in concomitant medications

Eligibility
Key inclusion criteria
Subjects must meet the following criteria to be entered into the study:
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 ICHD-3-beta2
3. Onset of migraine headache before age 50
4. Medical history of 2 – 8 migraine headache attacks per month for the previous 12 months; with at least 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 less than 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
8. Female subjects must be:
a) of non-child-bearing potential [surgically sterilised or postmenopausal (12 months with no menses without alternative medical cause)] OR
b) not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from screening to at least 28 days after the last IMP administration.
9. Male subjects with female partners of childbearing potential must useadequate and highly effective methods of contraception, from screening until 28 days after their last IMP administration.
10. Subjects must be sufficiently competent in English to understand the purposes
and risks of the study and to provide written informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who meet any of the following criteria will be excluded from the study:
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:
a. 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
b. 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 migrainosis or medication overuse headache within 6 months of screening
8. Current clinically significant systemic disease or neurological or psychiatric condition which in the opinion of the investigator or sponsor could jeopardise the safety of the subject or the validity of the study results
9. Cerebrovascular disease, including but not limited to a history of stroke or recent (3 years) transient ischaemic attack (TIA)
10. Major surgery within 6 weeks of screening or planned during the study period
11. Clinically significant abnormality as assessed by the investigator or sponsor’s medical monitor on haematology, biochemistry, vital signs, physical examination or 12-lead electrocardiogram (ECG)
12. Malignancy within 5 years of screening, with the exception of carcinoma in situ, non-melanoma skin cancers and prostate cancer not requiring treatment or on stable (> 6 months) treatment with hormone therapy
13. History of alcohol abuse, illicit or illegal drug use in the last 2 years
14. Use of prohibited medications or treatments within the specified time period before Screening or planned during the study
15. Participation in another clinical trial or administration of any investigational product or experimental product within 60 days or 5 half-lives (whichever is longer) prior to screening
16. History of significant hypersensitivity to LAT8881 (formerly known as AOD9604), excipients in the drug product formulation or drugs of a similar chemical or pharmacological class.
17. Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
18. An employee of the sponsor or research site personnel directly affiliated with this study, whether biological or legally adopted, or their immediate family members, defined as a spouse, parent, sibling, or child

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
Safety/efficacy
Statistical methods / analysis
No formal statistical sample size estimation has been performed due to the exploratory nature of this study. Rather the sample size is based on clinical and practical considerations.
The safety population includes all subjects who receive at least one dose of IMP and will be the population used for the analysis of safety endpoints. The full analysis set (FAS) population will be used to present demographic and other baseline characteristics and summaries of efficacy endpoints. A per-protocol (PP) population will be used as the primary population for efficacy analyses and to analyse exploratory endpoints. The PP population will be based on IMP exposure, including the time of any episodes of vomiting and major protocol deviations.
As this is a Phase IIa proof of concept study, no formal statistical hypotheses are being specified although some may be investigated as part of the data presentation. A p-value of <0.05 will be declared statistically significant. Treatment period order will be ignored in any treatment comparisons. Results will be presented in a descriptive format by treatment within each treatment period and overall. Treatment comparisons will take into account the paired nature of the treatment responses where feasible.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2019
Actual
4/10/2019
Date of last participant enrolment
Anticipated
27/01/2020
Actual
6/02/2020
Date of last data collection
Anticipated
31/03/2020
Actual
30/04/2020
Sample size
Target
26
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 14832 0
Emeritus Research - Camberwell
Recruitment hospital [2] 15146 0
Paratus Clinical Pty Ltd Blacktown Trial Clinic - Blacktown
Recruitment hospital [3] 15147 0
Paratus Clinical Pty Ltd Kanwal Trial Clinic - Kanwal
Recruitment postcode(s) [1] 28084 0
3124 - Camberwell
Recruitment postcode(s) [2] 28441 0
2148 - Blacktown
Recruitment postcode(s) [3] 28442 0
2259 - Kanwal

Funding & Sponsors
Funding source category [1] 303809 0
Commercial sector/Industry
Name [1] 303809 0
Lateral Pharma Pty Ltd
Country [1] 303809 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lateral Pharma Pty Ltd
Address
Level 14/114 William Street Melbourne VIC 3000 Australia
Country
Australia
Secondary sponsor category [1] 304003 0
None
Name [1] 304003 0
Address [1] 304003 0
Country [1] 304003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304325 0
Bellberry Ltd
Ethics committee address [1] 304325 0
Ethics committee country [1] 304325 0
Australia
Date submitted for ethics approval [1] 304325 0
31/07/2019
Approval date [1] 304325 0
13/09/2019
Ethics approval number [1] 304325 0
2019-07-637

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

Contacts
Principal investigator
Name 96546 0
Dr Louise Murdoch
Address 96546 0
Emeritus Research
Level 2/1180 Toorak Road Camberwell VIC 3124
Country 96546 0
Australia
Phone 96546 0
+61 39509 6166
Fax 96546 0
Email 96546 0
louisemurdoch@emeritusresearch.com
Contact person for public queries
Name 96547 0
Louise Murdoch
Address 96547 0
Emeritus Research
Level 2/1180 Toorak Road Camberwell VIC 3124
Country 96547 0
Australia
Phone 96547 0
+61 39509 6166
Fax 96547 0
Email 96547 0
louisemurdoch@emeritusresearch.com
Contact person for scientific queries
Name 96548 0
Nicky Wallis
Address 96548 0
Lateral Pharma Pty Ltd
Level 14/114 William Street Melbourne VIC 3000
Country 96548 0
Australia
Phone 96548 0
+61 438020177
Fax 96548 0
Email 96548 0
nwallis@lateral-pharma.com

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Although there appeared to be a trend for reduced ... [More Details]

Documents added automatically
No additional documents have been identified.