Menstrual MigrainePhase 2APH204NCT04102995
A Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
A Phase 2 study testing Sepranolone injection low dose and Sepranolone injection high dose in people with Menstrual Migraine, run by Asarina Pharma at 7 sites in 2 countries.
Trial summary
The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- Sepranolone injection low dose and Sepranolone injection high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 27 Aug 2019to 15 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- have Menstrual Migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) verified in three menstrual cycles
- have a regular menstrual cycle of 24-35 days cycle,
- use double barrier contraception, intrauterine device (IUD), be truly sexually abstinent, or subject or her partner has been surgically sterilized,
Who cannot join
- More than 10 headache days per month on average during screening phase
- steroid hormonal treatment during previous three months
- ongoing treatment with antiepileptic drugs or benzodiazepines
- significant medical or psychiatric condition
- be pregnant or plan a pregnancy within the study period
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Sweden4 sites
CTC Clinical Trial Center
Gothenburg
ProbarE i Lund
Lund, Skåne County, 22222
Karolinska Trial Alliance
Stockholm
CTC Clinical Trial Consultants
Uppsala
Finland3 sites
Suomen Terveystalo Plc
Helsinki
Suomen Terveystalo Plc
Tampere
Suomen Terveystalo Plc
Turku
About this study
Official title: An Exploratory Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms.
Sepranolone is identical to an endogenous steroid.
Read the detailed description
The objective of this phase 2 Proof-of-Concept study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle in comparison to placebo. Study treatment will be self-administrated as subcutaneous injections during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using an electronic migraine diary and a validated rating scale for assessment the physical and functional impact of menstrual migraine symptoms (MPFID). Preceding the treatment period, the diagnosis of Menstrual Migraine will be established by verifying menstrual migraine in at least two out of three menstrual cycles of daily symptom ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The reduction in average number of menstrual migraine days per menstrual cycle during the treatment period cycles vs. the three menstrual cycles of baseline will constitute the primary endpoint.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in three European countries (Sweden, Finland and Denmark) and will randomize 84 patients.
- Conditions
- Menstrual Migraine
- Being tested
- Sepranolone injection low dose, Sepranolone injection high dose, Placebo injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepranolone injection low doseDrug
Also called UC1010
Subcutaneous (SC) administration
Sepranolone injection high doseDrug
Also called UC1010
Subcutaneous (SC) administration
Placebo injectionDrug
Subcutaneous (SC) administration
| Study group | Role | What they receive |
|---|---|---|
| Sepranolone (UC1010) low dose | Experimental | Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine Receives: Drug: Sepranolone injection low dose |
| Sepranolone (UC1010) high dose | Experimental | Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine Receives: Drug: Sepranolone injection high dose |
| Placebo | Placebo comparator | Subcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of menstrual migraine days
Change from baseline in the average number of menstrual migraine days during three consecutive menstrual cycles
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start27 Aug 2019
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asarina Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102995
- Sponsor's protocol ID
- APH204
- Acronym
- APH204
- Status last verified
- Jul 2021
- First submitted
- 23 Sep 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase II, Randomised, Double-blind, Placebo-controlled, Parallel-group Study Investigating the Efficacy and Safety of Sepranolone in Women With Menstrual Migraine
- ClinicalTrials.gov ID
- NCT04102995
- Acronym / sponsor ID
- APH204 / APH204
- Conditions
- Menstrual Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Asarina PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this phase 2 Proof.of Concept study is to evaluate the efficacy and safety of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle. Patients will be taking Sepranolone or Placebo (blinded to patient and study doctor) during the two week preceding the menstruation for three menstrual cycles. Effect (change from baseline) will be assessed by comparison of symptoms recorded daily by the patients using an electronic diary using validated scales for assessment of menstual migraine symptoms.
Sepranolone is identical to an endogenous steroid.
Detailed description
The objective of this phase 2 Proof-of-Concept study is to evaluate the effect and safety of two doses of Sepranolone (UC1010) in preventing menstrual migraine attacks in adult women with migraine occurring between Day -2 and Day 5 of the menstrual cycle in comparison to placebo. Study treatment will be self-administrated as subcutaneous injections during the luteal phase of three consecutive menstrual cycles. Effect will be assessed by comparison of symptoms recorded daily by the patients using an electronic migraine diary and a validated rating scale for assessment the physical and functional impact of menstrual migraine symptoms (MPFID). Preceding the treatment period, the diagnosis of Menstrual Migraine will be established by verifying menstrual migraine in at least two out of three menstrual cycles of daily symptom ratings by the patients. This period will also constitute the baseline data. The effect of study medication will be assessed as the change in symptoms from baseline to during treatment. The reduction in average number of menstrual migraine days per menstrual cycle during the treatment period cycles vs. the three menstrual cycles of baseline will constitute the primary endpoint.
The study will also include a follow-up (no treatment) cycle before patients final visit.
The study is conducted in three European countries (Sweden, Finland and Denmark) and will randomize 84 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepranolone (UC1010) low dose | Experimental | Drug: Sepranolone injection low doseSubcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine |
| Sepranolone (UC1010) high dose | Experimental | Drug: Sepranolone injection high doseSubcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine |
| Placebo | Placebo comparator | Drug: Placebo injectionSubcutaneous injection every 48 hours during the luteal phase during three menstrual cycles in women with menstrual migraine |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- have Menstrual Migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) verified in three menstrual cycles
- have a regular menstrual cycle of 24-35 days cycle,
- use double barrier contraception, intrauterine device (IUD), be truly sexually abstinent, or subject or her partner has been surgically sterilized,
Key exclusion criteria (5 listed)
- More than 10 headache days per month on average during screening phase
- steroid hormonal treatment during previous three months
- ongoing treatment with antiepileptic drugs or benzodiazepines
- significant medical or psychiatric condition
- be pregnant or plan a pregnancy within the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sepranolone injection low doseAlso: UC1010Subcutaneous (SC) administration | Drug | Sepranolone (UC1010) low dose |
| Sepranolone injection high doseAlso: UC1010Subcutaneous (SC) administration | Drug | Sepranolone (UC1010) high dose |
| Placebo injectionSubcutaneous (SC) administration | Drug | Placebo |
Primary outcome
Change in number of menstrual migraine days
Time frame: Through study completion, an average of 6 months
Change from baseline in the average number of menstrual migraine days during three consecutive menstrual cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sepranolone injection low dose and Sepranolone injection high dose in people with Menstrual Migraine, run by Asarina Pharma at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of menstrual migraine days (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.