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    Summary
    EudraCT Number:2007-003307-13
    Sponsor's Protocol Code Number:07-001
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2007-003307-13
    A.3Full title of the trial
    A Phase 2a, Open-label, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects with Epileptic Seizures
    A.4.1Sponsor's protocol code number07-001
    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 SponsorJazz Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 nameIntranasal Clonazepam
    D.3.2Product code JZP-8
    D.3.4Pharmaceutical form Nasal spray*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONAZEPAM
    D.3.9.1CAS number 1622613
    D.3.9.2Current sponsor codeJZP-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    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 No
    D.IMP: 2
    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 nameIntranasal Clonazepam
    D.3.2Product code JZP-8
    D.3.4Pharmaceutical form Nasal spray*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLONAZEPAM
    D.3.9.1CAS number 1622613
    D.3.9.2Current sponsor codeJZP-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15.0
    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 No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent Acute Repetitive Seizures (ARS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039910
    E.1.2Term Seizures
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the minimum effective dose (MED) of intranasal clonazepam, defined as the lowest dose that can effectively reduce epileptiform activity in adult epilepsy subjects over the 24 hours following the onset of an epileptic seizure.
    E.2.2Secondary objectives of the trial
    - To establish the safety and tolerability of intranasal clonazepam at the MED and at one higher dose, up to 4 mg
    - To evaluate the PK characteristics of intranasal clonazepam at multiple dose levels, up to 4 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of refractory epilepsy (a failure of at least 2 antiepileptic drugs to control seizures) for at least 2 months prior to study start. Identifiable partial or generalized seizure types are allowed provided they have a clear or reproducible EEG component.
    2. Epilepsy subjects with a history of predictable daily seizure patterns. Subjects must average at least 7 seizures per week, with no more than 2 seizure-free days per week.
    3. No nasal conditions that would preclude the use of an intranasal product.
    4. Adult male and female subjects ages 18 to 65 years, inclusive.
    5. Body Mass Index (BMI) less than 35 kg/m2.
    6. Body weight no less than 100 lbs/45.5 kgs.
    7. Has maintained stable doses of concomitant AEDs for at least 1 month prior to study entry (Day -1).
    8. Willingness and ability to maintain a stable dose of current medications used to treat epilepsy (or other conditions) for the duration of the study
    9. Good general health as determined by physical and neurological examination, medical history, clinical laboratory findings, and ECG at screening, as determined by the investigator.
    10. Consent to use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, hormonal contraceptives, diaphragm and spermicide, intrauterine device (IUD), condom and vaginal spermicide, surgical sterilization, post-menopausal, and vasectomy (>6 months prior to Baseline).
    11. Negative drug and alcohol screens at screening and baseline (Day -1). Subjects who test positive for barbiturates and benzodiazepines will not be excluded from the study, provided these drugs have been prescribed as AEDs for treatment of their epilepsy or anxiety.
    12. No clinically significant hematological abnormalities in laboratory screening.
    13. Ability for subject to read, understand, and provide written informed consent before enrolling in the study, and willingness to comply with all study procedures.
    14. Agreement to remain in the study facility for the duration of the study (up to 9 calendar days).
    15. Negative pregnancy test for all females at screening and baseline (Day -1).
    E.4Principal exclusion criteria
    1. Subjects with a clinically significant unstable medical abnormality, chronic disease, or history or presence of significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, psychiatric, or metabolic disease or any other abnormality (other than epilepsy) that could interfere with evaluation of the study drug.
    2. Subjects in the EMU for pre-surgical evaluation.
    3. Biochemical evidence of significant liver disease at screening.
    4. Subjects who have experienced psychogenic non-epileptic seizures within the last 2 years.
    5. Vagus nerve stimulator (VNS) implant within 3 months prior to enrollment (Day -1) or VNS setting adjusted within 30 days prior to enrollment.
    6. Subjects who have experienced status epilepticus within the last 12 months.
    7. Acute narrow angle glaucoma.
    8. Subjects with any severe drug allergy, history of allergic or severe adverse drug reactions, or intolerance to clonazepam, other benzodiazepines, or the excipients used in the intranasal spray.
    9. Subjects taking more than three concurrent AEDs (may be included after consultation with the medical monitor).
    10. Subjects currently or regularly taking clonazepam
    11. Use of an epilepsy rescue medication within five drug half-lives of clinic entry (Day -1).
    12. Use of an OTC or prescription intranasal product within five drug half-lives of clinic entry (Day -1).
    13. Subjects who require the use of a rescue medication more than twice per week.
    14. Subjects with clinically significant illness (other than refractory epilepsy) within 30 days of screening, as determined by the investigator.
    15. Subjects with a clinically significant abnormal finding (other than epilepsy) on physical or neurological examination, ECG, or clinical laboratory tests, as determined by the investigator at screening.
    16. Subjects with a history of alcohol or drug abuse that in the investigator’s judgment will affect the subject’s safety and/or ability to complete the study.
    17. Females who are pregnant, breastfeeding, or lactating.
    18. Subjects who self-report ingestion of alcohol within 48 hours prior to dosing through completion of the study.
    19. Subjects who used any other investigational drug or device within 30 days or five half-lives (whichever is longer) before clinic entry (Day -1), or plans to use an investigational drug (other than the study drug) during the study.
    20. Subjects who have made any blood donation within 56 days of clinic entry (Day -1).
    21. Subjects who have made any plasma donation within 7 days of clinic entry (Day -1).
    22. Subjects who cannot understand or comply with the study procedures or whom the investigator suspects cannot understand or comply with the procedures.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is change in epileptiform activity. In particular, the following endpoints will be analyzed:
    • Number of spikes and sharp waves
    • Number of spike-wave bursts lasting more than one second
    • Electroclinical seizures
    These endpoints will be measured from 24-hour video EEG recordings that will be compared between Baseline and Treatment Days.
    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 Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 45
    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)
    Subjects will return to their expected normal treatment for their condition.
    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 Decision2008-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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