Menstrual migraine MedDRA version: 20.0 Level: LLT Classification code 10065540 Term: Menstrual migraine System Organ Class: 100000004852
Conditions
Interventions
Product Name: Sepranolone
Product Code: UC1010
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: SEPRANOLONE
Sponsors
Asarina Pharma ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria The woman must: 1. provide her informed consent prior to any study related procedures 2. be aged =18 and =45 years. 3. have a regular menstrual cycle of 24-35 days 4. use sufficient barrier contraception, IUD, be truly abstinent or the woman or her male sexual partner has been surgically sterilized (further described in Section 4.3.1). 5. have a history of migraine according to the IHS classification ICHD-3 with a history of at least 12 months with migraine in conjunction with menstruation and in at least 2 out of 3 ovulatory menstrual cycles. 6. for randomisation, have documented menstrual migraine attacks during at least two menstrual cycles out of the three-cycle screening and baseline period. A menstrual migraine attack is defined as starting at a time between Day -2 and Day +3 of full menstrual flow (limits inclusionary) Further, the woman may 7. have a total of maximum ten (10) migraine or other headache days per month. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria The woman must not have: 1. participated in a clinical study and received active drug in such a study within 30 days or 5 study drug half-lives, whichever the longest, prior to the first study visit. 2. in the investigator's opinion, evidence and/or history of any clinically significant neurological disease, other intracranial or systemic diseases or conditions potentially interfering with study assessments 3. a BMI >35 kg/m2. 4. or has had a malignant disease within the previous 5 years (except non-melanoma skin cancer, cervical or breast ductal carcinoma in situ) 5. HIV or ongoing hepatitis by history 6. have allergies to ingoing study drug components including egg allergy or a history of anaphylactic reactions. 7. have a less than 80% compliance with eDiary reporting during Days -7 until + 7 in each of the three-cycle baseline periods. The woman must not be: 8. suffering any other medically significant and unstable disease potentially interfering with or being negatively affected by participation in the study, as judged by the investigator. 9. pregnant or breast-feeding, or planning pregnancy during the study period 10. taking any systemic steroid hormonal treatment during 3 months before the study visit. Topical corticosteroids and stable doses of inhalational treatment for asthma or seasonal allergy may be allowed. For injectable hormonal contraceptives, a 6-month washout is required. 11. previously been diagnosed with a major psychiatric disorder according to DSM 5® criteria, including drug abuse or dependency 12. taking disallowed medications or allowed with restrictions with respect to their use prior to or during the study (this list is not comprehensive). Disallowed medications include: corticosteroids, OCTs, over-the-counter or prescription drugs for PMS symptoms, including but not limited to, bioidentical hormones, St John’s wort, Evening primrose oil, Agnus castor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of two different doses (10 mg and 16 mg) of sepranolone on number of menstrual migraine days compared with placebo in patients with menstrual migraine. ; Secondary Objective: To investigate the treatment efficacy of Sepranolone as assessed by amount of symptomatic treatment needed To evaluate the effect of two different doses (10 mg and 16 mg) of sepranolone on number of menstrual migraine days compared with placebo in patients with menstrual migraine. To investigate the responder rate of Sepranolone on menstrual migraine To investigate the effect of Sepranolone on auxiliary migraine symptoms To evaluate the effect of Sepranolone on menstrual migraine related physical and functional impairment in women with menstrual migraine To evaluate the effect of Sepranolone on the impact of menstrual migraine on everyday activities in patients with menstrual migraine To evaluate the effect of Sepranolone on the impact of menstrual migraine on overall daily activities in women with menstrual migraine To measure Sepranolone exposure ; Primary end point(s): Reduction in the menstrual cycle mean number of menstrual migraine Days. The menstrual cycles need to be ovulatory as demonstrated by mid-luteal phase elevated progesterone levels. ;Timepoint(s) of evaluation of this end point: During Day -2 to Day +5 of three menstrual cycles, compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1, 9 During Day -2 to Day +5 during three consecutive menstrual cycles. 2. Between Day -2 to Day +5 during the last two out of three consecutive menstrual cycles. 3. Between Day -2 to Day +5 during three consecutive menstrual cycles. 4. Between Day -2 to Day +5 during the last two out of three consecutive menstrual cycles. 5. During Days -2 to Day +5 vs. baseline. 8. 6, 7, 9, 14 During three consecutive menstrual cycles 6, 7, 9 During the last two out of three consecutive menstrual cycles. 8. During Day –2 – Day +5 during the last two out of three consecutive menstrual cycles. 10. Blood sampling done on Day -7 ±2 during screening and each treatment cycle. 11. During three menstrual cycles, compared to baseline 12. Mean number of migraine days per month, compared to baseline ; Secondary end point(s): 1. Change from baseline in the menstrual cycle number of doses of rescue symptomatic medication taken. 2. Change from baseline of the menstrual cycle mean number of migraine Days. The menstrual cycles need to be ovulatory as demonstrated by mid-luteal phase elevated progesterone levels. 3. Change from baseline of the menstrual cycle mean number of days with moderate or severe migraine. 4. Change from baseline of number of days with moderate or severe migraine. 5. Proportion of women having 30%-50%-75%-100% or more reduction in number of migraine Days. 6. Change from baseline in the menstrual cycle auxiliary migraine symptoms in patients’ reporting of associated symptoms (nausea, vomiting, photophobia, phonophobia) 7. Change from baseline in the menstrual cycle on the Migraine Physical Function Impact Diary score 24-hour rec | — |
Countries
Denmark, Finland, Sweden
Contacts
Public ContactAnna Runeson
Scandinavian CRO AB
Outcome results
None listed