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    Summary
    EudraCT Number:2006-005991-41
    Sponsor's Protocol Code Number:OPTUK MSPP PRO002
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-22
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-005991-41
    A.3Full title of the trial
    A multicentre, double-blind, placebo-controlled evaluation of intranasal sumatriptan delivered with the OptiNose powder device in the treatment of acute migraine.
    A.4.1Sponsor's protocol code numberOPTUK MSPP PRO002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOptiNose UK Ltd.
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMigraine Sumatriptan Powder Product
    D.3.2Product code MSPP
    D.3.4Pharmaceutical form Nasal powder
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsumatriptan succinate
    D.3.9.1CAS number 8000080026
    D.3.9.3Other descriptive nameSUMATRIPTAN SUCCINATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMSPP is a single use nasal drug delivery device delivering 10 mg of sumatriptan base to the nasal cavity using a rotate capsule principle. It contains a HPMC capsule filled with sumatriptan.
    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 placeboNasal powder
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Treatment of Migraine with or without Aura
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    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 efficacy of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of intranasal sumatriptan at a dose of either 10 mg or 20 mg delivered with the OptiNose powder device during a single migraine episode.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult subjects of either gender, aged 18-65 years.
    2. A developing or established attack of migraine with or without aura according to the International Headache Society criteria, of moderate (grade 2) or severe (grade 3) intensity and the attack not improving at the time of assessment.
    3. Migraine should have been present for at least 1 year and the subject should have a 3-month well-documented retrospective history.
    4. The subject should have 48 hours of freedom from headache between attacks of migraine.
    5. The subject’s age at first diagnosis of migraine should be less than 50 years.
    6. An average of > 1 and < 6 migraine attacks per month for the past 6 months.
    7. Female subjects of childbearing potential who practice an acceptable form of contraception and with a negative urine pregnancy test prior to dosing. Female subjects may be included without a negative urine pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
    8. Subjects must report the migraine attack and attend the clinic within 4 hours of the onset of the attack.
    9. Subjects must have verified airflow through both nostrils and an ability to close their soft palate.
    10. Ability to create bidirectional flow using a placebo OptiNose powder device in accordance with the Instructions for Use with a nasal outflow of ≥20 L/min.
    11. Willing and able to give written informed consent and comply with the study requirements.
    E.4Principal exclusion criteria
    1. An inability to distinguish other headaches from migraine.
    2. Subjects who have other headaches at a frequency of more than 6 days per month.
    3. Subjects who use drugs excessively for headache, that is who use medication for acute headache more than 10 days each month.
    4. Subjects who are resistant to migraine drugs.
    5. Use of ergotamine, ergot-type medications, any 5-HT1 agonist or narcotic analgesics within the previous 24 hours before treatment.
    6. Current use of drugs for migraine prophylaxis. Subjects who have used drugs for migraine prophylaxis in the past but have not done so for 1 month prior to the screening may be included.
    7. Use of any analgesic within the previous 12 hours before treatment.
    8. Subjects undergoing treatment with monoamine oxidase A (MAO-A) inhibitors or attending for treatment within 2 weeks of discontinuation of MAO-A inhibitor therapy.
    9. Subjects undergoing treatment with selective serotonin reuptake inhibitors (SSRIs).
    10. Subjects who have taken antipsychotics or antidepressant medications (unless for migraine prophylaxis) during the previous 3 months.
    11. Subjects who have used a decongestant within 6 hours of their attendance at the clinic on the treatment day.
    12. Subjects with hemiplegic or basilar migraine.
    13. Subjects with a history, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes.
    14. Subjects with uncontrolled hypertension (baseline systolic/diastolic blood pressure >140/95 mm Hg).
    15. Subjects with severe hepatic impairment.
    16. Subjects with epilepsy.
    17. Subjects with any uncontrolled major psychiatric illness.
    18. Subjects who abuse alcohol or other drugs.
    19. Subjects with any systemic disease which in the opinion of the Investigator would contraindicate participation.
    20. Subjects with a history of hypersensitivity or intolerance to sumatriptan, any of its components or sulphonamides.
    21. Pregnant or lactating women.
    22. Subjects who have taken any investigational medication within 3 months prior to the study drug (Visit 2), or are scheduled to receive an investigational drug other than sumatriptan while participating in the study.
    23. Subjects with known nasal obstruction due to nasal deviations, polyposis, severe mucosal swelling or any other reason.
    24. Subjects with current uncontrolled nasopharyngeal illness.
    25. Subjects with known velum insufficiency, - i.e. those with cleft palate and/or structural abnormalities in the soft palate and nasopharynx.
    26. Subjects who have undergone extensive nasal and/or sinus surgery.
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of subjects treated with sumatriptan pain free at 120 minutes post- dose compared to placebo.
    - Relief of headache at each timepoint.
    - Time to meaningful relief.
    - Level of functional disability.
    - Requirement for rescue medication.
    - Incidence of associated symptoms.
    - Sustained pain free.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    The trial will terminate as soon as the required number of patients are available
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state170
    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)
    Standard treatment of migraine.
    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 Decision2007-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-13
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