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Trial registered on ANZCTR


Registration number
ACTRN12625000333415
Ethics application status
Approved
Date submitted
7/04/2025
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety-Tolerability of a Single Oral Dose of EP102 200mg or 400mg Self-Administered at Home By Adult Participants Experiencing Moderate to Severe Migraine Headache
Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety-Tolerability of a Single Oral Dose of EP102 200mg or 400mg Self-Administered at Home By Adult Participants Experiencing Moderate to Severe Migraine Headache
Secondary ID [1] 314018 0
EP102-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Headache 336760 0
Condition category
Condition code
Neurological 333250 333250 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with receive a bottle of investigational product (IP) containing two oral capsules. The bottle of the investigational product will contain either:
• EP102: 2 capsules, each containing 200 mg of EP102 (total of 400 mg of EP102-04)
• EP102: 1 capsule containing 200 mg of EP102 and 1 capsule containing placebo (total of 200 mg of EP102-04)
• Placebo: 2 capsules, each containing placebo ( no active medication)

Participants will visit the clinical trial centre three (3) times in total:
• Visit 1 - a screening visit to see if you are eligible for the trial
• Visit 2 - for a final eligibility check and for administration of a test-dose of the investigational product
• Visit 3 - 3-10 days after the participant has self-administered the investigational product at home

Single oral dose of EP102 200, EP102 400 mg, or placebo will be administered as a test dose in the clinic while the participant is not experiencing a migraine attack. This is being conducted to assess the safety and tolerability of a single oral dose of EP102 200 mg or EP102 400 mg. This will be evaluated by the collecting of adverse events, changes in vital signs, oxygen saturation, and results of orthostatic testing. If orthostatic hypotension is diagnosed after randomization at Visit 2 at the test dose the participant is to be withdrawn from the study.

Randomized participants will have up to 45 days after the randomization visit (Visit 2) to treat a qualifying migraine headache of at least moderate pain severity with the assigned blinded IP.

Participants will be instructed to store the bottles in a cool dry place outside of direct sunlight. Participants are to bring their IP bottles with them to the end-of-study visit for IP accountability.

Participants must agree to adhere to clinic visits and all other requirements of the study.
Intervention code [1] 330599 0
Treatment: Drugs
Comparator / control treatment
Placebo

The placebo (lactose monohydrate) is formulated for oral administration and supplied in hydroxypropyl methylcellulose (HPMC) capsules identical to those used for EP102.
Control group
Placebo

Outcomes
Primary outcome [1] 340815 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving freedom from migraine headache pain at 2 hours post-dose
Timepoint [1] 340815 0
2 hours post-dose
Secondary outcome [1] 445129 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving freedom from the participant’s most bothersome symptom (MBS) at 2 hours post-dose
Timepoint [1] 445129 0
2 hours post-dose
Secondary outcome [2] 445130 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving headache pain relief at 2 hours post-dose
Timepoint [2] 445130 0
2 hours post-dose
Secondary outcome [3] 445131 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving a clinical response at 2 hours post-dose
Timepoint [3] 445131 0
2 hours post-dose
Secondary outcome [4] 445132 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving sustained freedom from migraine headache pain from 2 to 24 or from 2 to 48 hours post-dose
Timepoint [4] 445132 0
2 to 24 or from 2 to 48 hours post-dose
Secondary outcome [5] 445133 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving sustained freedom from the participant’s most bothersome symptom from 2 to 24 or from 2 to 48 hours post-dose
Timepoint [5] 445133 0
2 to 24 or from 2 to 48 hours post-dose
Secondary outcome [6] 445134 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving sustained headache pain relief from 2 to 24 or from 2 to 48 hours post-dose
Timepoint [6] 445134 0
2 to 24 or from 2 to 48 hours post-dose
Secondary outcome [7] 445135 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving total freedom from migraine from 2 to 24, and from 2 to 48 hours post-dose
Timepoint [7] 445135 0
2 to 24, and from 2 to 48 hours post-dose
Secondary outcome [8] 445136 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving freedom from nausea/vomiting at 2 hours post-dose
Timepoint [8] 445136 0
2 hours post-dose
Secondary outcome [9] 445137 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving freedom from photophobia at 2 hours post-dose
Timepoint [9] 445137 0
2 hours post-dose
Secondary outcome [10] 445138 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg in achieving freedom from phonophobia at 2 hours post-dose
Timepoint [10] 445138 0
2 hours post-dose
Secondary outcome [11] 445139 0
To evaluate participants’ use of rescue medication after a single oral dose of EP102 200 mg or EP102 400 mg
Timepoint [11] 445139 0
1-2, 4-24 and 48-hour post-dose
Secondary outcome [12] 445140 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg on participants’ self-assessment of their ability to function
Timepoint [12] 445140 0
Pre-dose to 2 hours, 4 hours, and 24 hours post-dose
Secondary outcome [13] 445141 0
To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg on participants’ global impression of change
Timepoint [13] 445141 0
24 hours post-dose
Secondary outcome [14] 445142 0
To evaluate participants’ impression of the Investigational Product after a single dose of EP102 200 mg or EP102 400 mg
Timepoint [14] 445142 0
24 hours post-dose
Secondary outcome [15] 445143 0
To assess the safety and tolerability of a single oral dose of EP102 200 mg or EP102 400 mg self-administered by the participant for acute treatment of moderate or severe migraine
Timepoint [15] 445143 0
Between screening and the end-of-study

Eligibility
Key inclusion criteria
Age 18 to 65 years at the time of signed informed consent
Age at onset of migraine attacks 1 year
History of 2 to 8 migraine attacks with moderate or severe pain on average per month for the 3 months prior to the screening visit
Fewer than 15 days with headaches (migraine or non-migraine) per month for the 3 months prior to the screening visit
Body weight 50.0 kg to 100 kg
Body mass index (BMI) 18.0 to 35.0 kg/m2
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of hemiplegic migraine (at any time in the past)
History of both tension-type headaches, and migraine and participant is unable to distinguish between them
Major surgery within 6 months prior to screening,
Diagnosis of sleep apnoea
Recurrent syncope (vasovagal or other)
Overuse of medications for migraine or other conditions during the 3 months prior to screening
=10 days/month for 3 months
Opioids (narcotics)
Triptans
Benzodiazepines, barbiturates, sleeping aids
iHerbal supplements and natural health products used for acute treatment of migraine
=15 days/month for 3 months
Simple analgesics (e.g., aspirin, NSAIDs, paracetamol

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet the inclusion/exclusion criteria will be randomly assigned at a 1:1:1 ratio in blocks of 6 to receive EP102 200 mg or EP102 400 mg, or matching placebo. Each participant will receive the same assigned IP for both the test dose and the at-home treatment dose. Site investigators and participants will be blinded to study assignment. Randomization will occur centrally using interactive response technology (IRT) with an interactive web response (IWR) system.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study is not intended to test a specific hypothesis. Rather, the planned analysis will determine the odds ratios (active/placebo) for the efficacy endpoints together with 95% confidence intervals around these estimates.
The primary efficacy variable will be evaluated with the use of a logistic-regression model that includes categorical terms for the following covariates, as appropriate: history of response to triptan (triptan responder, triptan insufficient responder, or triptan naïve46), use of medication for migraine prevention (yes, no), and baseline (pre-dose) severity of the qualifying migraine headache (moderate or severe).
Secondary efficacy endpoints will be analyzed with a similar logistic regression model. For the underlying symptom that was identified as the MBS and for individual migraine-associated symptoms, an additional categorical term (baseline presence/absence of the symptom) will be used.
Exploratory analyses may include time from headache pain onset to treatment as a covariate for logistic regression analyses.
Paired comparisons will be conducted for EP102 200 mg and EP102 400 mg vs placebo. Results will be summarized as odds ratios (active/placebo) presented with 95% confidence intervals around the estimate.
A complete description of the statistical analyses to be performed will be presented in the SAP, which will be developed and finalized before database lock.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
24/07/2026
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 43861 0
5034 - Wayville
Recruitment postcode(s) [2] 43862 0
2077 - Waitara
Recruitment postcode(s) [3] 43863 0
3021 - St Albans
Recruitment postcode(s) [4] 43864 0
4068 - Taringa
Recruitment postcode(s) [5] 43865 0
4121 - Wellers Hill
Recruitment postcode(s) [6] 43866 0
2010 - Darlinghurst
Recruitment postcode(s) [7] 43867 0
3168 - Clayton
Recruitment postcode(s) [8] 43868 0
2100 - Brookvale
Recruitment postcode(s) [9] 43869 0
2228 - Miranda
Recruitment postcode(s) [10] 43870 0
2500 - Wollongong
Recruitment postcode(s) [11] 43871 0
2060 - North Sydney
Recruitment postcode(s) [12] 43872 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 318522 0
Commercial sector/Industry
Name [1] 318522 0
Epalex Australia
Country [1] 318522 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Epalex Australia
Address
Country
Australia
Secondary sponsor category [1] 320917 0
None
Name [1] 320917 0
Address [1] 320917 0
Country [1] 320917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317128 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 317128 0
Ethics committee country [1] 317128 0
Australia
Date submitted for ethics approval [1] 317128 0
06/12/2023
Approval date [1] 317128 0
02/02/2024
Ethics approval number [1] 317128 0
2023-12-1518

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

Contacts
Principal investigator
Name 140090 0
Dr Matthew Green
Address 140090 0
PainMedSA, 5 Greenhill Road, Wayville SA 5034
Country 140090 0
Australia
Phone 140090 0
+61 418 148 710
Fax 140090 0
Email 140090 0
[email protected]
Contact person for public queries
Name 140091 0
Jill Randall
Address 140091 0
Molecule2Market, Level 8, 90 Collins Street, Melbourne. VIC 3000
Country 140091 0
Australia
Phone 140091 0
+61 481 860 960
Fax 140091 0
Email 140091 0
[email protected]
Contact person for scientific queries
Name 140092 0
Dr Allen Heller
Address 140092 0
Epalex Corporation 1049 El Monte Avenue Suite C 585 Mountain View, CA 94040
Country 140092 0
United States of America
Phone 140092 0
+1 203 278 1860
Fax 140092 0
Email 140092 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not required



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.