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    Summary
    EudraCT Number:2019-001081-15
    Sponsor's Protocol Code Number:APH204
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2019-001081-15
    A.3Full title of the trial
    An exploratory phase II, randomised, double-blind, placebo-controlled, parallel-group study investigating the efficacy and safety of Sepranolone in women with menstrual migraine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effectiveness and safety of study drug (sepranolone) in women with menstrual migraine
    A.4.1Sponsor's protocol code numberAPH204
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAsarina Pharma ApS
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAsarina Pharma ApS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScandinavian CRO AB
    B.5.2Functional name of contact pointAnna Runeson
    B.5.3 Address:
    B.5.3.1Street AddressSkolgatan 8
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75015
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703033508
    B.5.6E-mailanna.runeson@scro.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSepranolone
    D.3.2Product code UC1010
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSEPRANOLONE
    D.3.9.1CAS number 516-55-2
    D.3.9.2Current sponsor codeUC1010
    D.3.9.4EV Substance CodeSUB33700
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSEPRANOLONE
    D.3.9.1CAS number 516-55-2
    D.3.9.2Current sponsor codeUC1010
    D.3.9.4EV Substance CodeSUB33700
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Menstrual migraine
    E.1.1.1Medical condition in easily understood language
    Menstrual migraine
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065540
    E.1.2Term Menstrual migraine
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During Day -2 to Day +5 of three menstrual cycles, compared to baseline.
    E.5.2Secondary 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 recall version during Day –2 – Day +5.
    8. Change from baseline in the menstrual cycle on the composite functional endpoint/ MM scale Change from baseline in Migraine Physical Function Impact Diary score 24-hour recall version.
    9. Change from baseline in the menstrual cycle on the global impact on daily activities endpoint/ MM scale Change from baseline in Migraine Physical Function Impact Diary score 24-hour recall version.
    10. Plasma levels of isoallopregnanolone.
    11.Reduction in the menstrual cycle mean number of migraine days per menstrual cycle . The menstrual cycles need to be ovulatory as demonstrated by mid-luteal phase elevated progesterone levels.
    12. Reduction in the menstrual cycle mean number of migraine days per month, compared to baseline. The menstrual cycles need to be ovulatory as demonstrated by mid-luteal phase elevated progesterone levels.
    13. Reduction in the menstrual cycle mean number of migraine Days during the full treatment period, compared to baseline . The menstrual cycles need to be ovulatory as demonstrated by mid-luteal phase elevated progesterone levels.
    14. Change from baseline in the menstrual cycle number of doses of rescue symptomatic medication taken per menstrual cycle .
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 84
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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