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DEFINITIONS
Trial Review
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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
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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
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Secondary ID [1]
314018
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EP102-04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine Headache
336760
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Condition category
Condition code
Neurological
333250
333250
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330599
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Treatment: Drugs
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Proportion of participants reporting reduction of headache pain from moderate or severe pre-dose to no pain at 2 hours post-dose, with no use of rescue medication. (Pain to be measured on a 4-point scale: 0 = no pain, 1 = mild, 2 = moderate, 3 = severe.)
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Timepoint [1]
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2 hours post-dose
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Secondary outcome [1]
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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
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Assessment method [1]
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Proportion of participants reporting absence of their most bothersome symptom at 2 hours post-dose, with no use of rescue medication (MBS [nausea/vomiting, photophobia, or phonophobia] to be identified pre-dose and assessed as 0 = absent or 1 = present at 2 hours post-dose.)
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Timepoint [1]
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2 hours post-dose
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Secondary outcome [2]
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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
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Assessment method [2]
445132
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Proportion of participants who report not experiencing any headache pain, with no use of rescue medication, through the period of interest
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Timepoint [2]
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2 to 24 or from 2 to 48 hours post-dose
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Secondary outcome [3]
445131
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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
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Assessment method [3]
445131
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Proportion of participants reporting improvement of at least 2 points on the 4-point pain scale from baseline to 2 hours post-dose, with no use of rescue medication.
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Timepoint [3]
445131
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2 hours post-dose
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Secondary outcome [4]
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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
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Assessment method [4]
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Proportion of participants who report the absence of nausea and vomiting at 2 hours post-dose in the subset of subjects who reported the presence of nausea or vomiting pre-dose
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Timepoint [4]
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2 hours post-dose
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Secondary outcome [5]
445137
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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
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Assessment method [5]
445137
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Proportion of participants who report the absence of photophobia at 2 hours post-dose in the subset of subjects who reported the presence of photophobia pre-dose
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Timepoint [5]
445137
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2 hours post-dose
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Secondary outcome [6]
445133
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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
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Assessment method [6]
445133
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Proportion of participants who report not experiencing their most bothersome symptom, with no use rescue medication, through the period of interest
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Timepoint [6]
445133
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2 to 24 or from 2 to 48 hours post-dose
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Secondary outcome [7]
445135
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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
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Assessment method [7]
445135
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Proportion of participants who report not experiencing any headache pain and not experiencing their most bothersome symptom, with no use of rescue medication, through the period of interest
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Timepoint [7]
445135
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2 to 24, and from 2 to 48 hours post-dose
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Secondary outcome [8]
445142
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To evaluate participants’ impression of the Investigational Product after a single dose of EP102 200 mg or EP102 400 mg
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Assessment method [8]
445142
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Proportion of participants reporting their impression of the Investigational Product as good or excellent at 24 hours post-dose Proportion of participants reporting their impression of the Investigational Product as the same as, better, or much better than their usual acute migraine therapy Proportion of participants basing their comparison of the Investigational Product with their usual medication on efficacy, side effects alone, or both. This data will be collected by study specific questionnaires in the participants diary.
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Timepoint [8]
445142
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24 hours post-dose
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Secondary outcome [9]
445130
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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
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Assessment method [9]
445130
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Proportion of participants reporting improvement from moderate or severe headache pain (2 or 3 on the 4-point pain scale) pre-dose to mild or no pain (1 or 0) at 2 hours post-dose, with no use of rescue medication
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Timepoint [9]
445130
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2 hours post-dose
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Secondary outcome [10]
445143
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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
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Assessment method [10]
445143
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Safety and tolerability will be assessed via adverse events, changes between screening and the end-of-study visit in laboratory tests, results of physical and neurological examinations, and the Sheehan Suicidality Tracking Scale . Potential adverse events include pruritus, somnolence, mild decreases in diastolic blood pressure after standing up from a lying position, syncope after standing up from a lying position and feeling drunk.
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Timepoint [10]
445143
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Between screening and the end-of-study
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Secondary outcome [11]
445141
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To evaluate the effect of a single oral dose of EP102 200 mg or EP102 400 mg on participants’ global impression of change
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Assessment method [11]
445141
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Proportion of participants with a global impression of change score of much improved or very much improved at 24 hours post-dose
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Timepoint [11]
445141
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24 hours post-dose
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Secondary outcome [12]
445138
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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
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Assessment method [12]
445138
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Proportion of participants who report the absence of phonophobia at 2 hours post-dose in the subset of subjects who reported the presence of phonophobia pre-dose
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Timepoint [12]
445138
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2 hours post-dose
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Secondary outcome [13]
445140
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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
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Assessment method [13]
445140
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Change in score on the self-assessment of ability to function (4-point scale) from pre-dose to 2 hours, 4 hours, and 24 hours post-dose; proportion of participants with a rating of able to function normally at 2 hours, 4 hours, and 24 hours post-dose
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Timepoint [13]
445140
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Pre-dose to 2 hours, 4 hours, and 24 hours post-dose
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Secondary outcome [14]
445134
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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
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Assessment method [14]
445134
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Proportion of participants who report not experiencing any moderate or severe headache pain, with no use rescue medication, through the period of interest
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Timepoint [14]
445134
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2 to 24 or from 2 to 48 hours post-dose
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Secondary outcome [15]
445139
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To evaluate participants’ use of rescue medication after a single oral dose of EP102 200 mg or EP102 400 mg
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Assessment method [15]
445139
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Cumulative proportion of participants who report taking rescue medication before the 1-, 2¬, 4-, 24-, and 48-hour post-dose assessment time points
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Timepoint [15]
445139
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1-2, 4-24 and 48-hour post-dose
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last participant enrolment
Anticipated
1/06/2026
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Actual
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Date of last data collection
Anticipated
24/07/2026
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Actual
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Sample size
Target
480
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment postcode(s) [1]
43865
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4121 - Wellers Hill
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Recruitment postcode(s) [2]
43868
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2100 - Brookvale
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Recruitment postcode(s) [3]
43864
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4068 - Taringa
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Recruitment postcode(s) [4]
43861
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5034 - Wayville
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Recruitment postcode(s) [5]
43866
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2010 - Darlinghurst
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Recruitment postcode(s) [6]
43867
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3168 - Clayton
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Recruitment postcode(s) [7]
43871
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2060 - North Sydney
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Recruitment postcode(s) [8]
43862
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2077 - Waitara
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Recruitment postcode(s) [9]
43872
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4215 - Southport
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Recruitment postcode(s) [10]
43863
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3021 - St Albans
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Recruitment postcode(s) [11]
43869
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2228 - Miranda
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Recruitment postcode(s) [12]
43870
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2500 - Wollongong
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
318522
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Epalex Australia
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Address [1]
318522
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Country [1]
318522
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Epalex Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320917
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None
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Name [1]
320917
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Address [1]
320917
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Country [1]
320917
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee H
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Ethics committee address [1]
317128
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https://bellberry.com.au
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Ethics committee country [1]
317128
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Australia
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Date submitted for ethics approval [1]
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06/12/2023
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Approval date [1]
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02/02/2024
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Ethics approval number [1]
317128
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2023-12-1518
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Summary
Brief summary
The primary purpose of the study is to assess the safety and tolerability of a single oral dose of EP102 200 mg or 400 mg self-administered at home by adult participants experiencing moderate-to-severe migraine headache.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Matthew Green
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Address
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PainMedSA, 5 Greenhill Road, Wayville SA 5034
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Country
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Australia
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Phone
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+61 418 148 710
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jill Randall
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Address
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Molecule2Market, Level 8, 90 Collins Street, Melbourne. VIC 3000
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Country
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Australia
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Phone
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+61 481 860 960
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Fax
140091
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Allen Heller
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Address
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Epalex Corporation 1049 El Monte Avenue Suite C 585 Mountain View, CA 94040
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Country
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United States of America
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Phone
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+1 203 278 1860
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Fax
140092
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Email
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[email protected]
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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.
Download to PDF