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    Summary
    EudraCT Number:2013-005107-13
    Sponsor's Protocol Code Number:002083935121
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-08-28
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-005107-13
    A.3Full title of the trial
    A pilot study of the use of oral modafinil added to standard care in hypercapnic respiratory failure in COPD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study of modafinil add to standard care in Type-2 respiratory failure in COPD
    A.3.2Name or abbreviated title of the trial where available
    modafinil in hypercapnic respiratory failure
    A.4.1Sponsor's protocol code number002083935121
    A.5.4Other Identifiers
    Name:R&D numberNumber:017/2014 SMED/D6
    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 SponsorEpsom and St Helier University Hospitals NHS Trust R&D Dpt
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationYvonne Reilly
    B.5.2Functional name of contact pointManager of R&D Dept St Helier Hosp
    B.5.3 Address:
    B.5.3.1Street AddressWrythe Lane
    B.5.3.2Town/ cityCarshalton, surrey
    B.5.3.3Post codeSM51AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020829636324699
    B.5.5Fax number02082963165
    B.5.6E-mailyvonne.reilly@esth.nhs.uk
    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 Yes
    D.2.1.1.1Trade name modafinil
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namemodafinil dry powder tablet
    D.3.2Product code Pl 16260/0002
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmodafinil
    D.3.9.1CAS number ATC N06BA07
    D.3.9.2Current sponsor codePL16260/0002
    D.3.9.3Other descriptive nameprovigil
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypercapnic respiratory failure in COPD
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease with type-2 respiratory failure where blood carbon dioxide levels are chronically raised due to inability of the lungs to breathe at an adequate rate.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Does oral modafinil improve arterial oxygen levels and reduce arterial carbon dioxide levels in patients with chronic hypercapnic respiratory failure and COPD. We will look at percentage improvement in oxygen levels and percentage reduction in carbon dioxide levels.
    E.2.2Secondary objectives of the trial
    1.Tolerability
    2.Improve day and overnight oxygen levels measured by oximetry.
    3.Improve quality of life scores
    4.Spirometry
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i. Male or female.
    ii. Aged 40 – 86 years
    iii. An established clinical history consistent with COPD and known chronic hypercapnic respiratory failure on standard treatments.
    iv. Arterial gases confirming known hypercapnia with PaO2 below 8.1kPa and arterial carbon dioxide level >7.5 kPa in the absence of an exacerbation.
    v. No use of oxygen or nasal ventilator nor CPAP machine
    vi. Able to comply with questionnaires and assessments
    vii. No history of significant renal or liver failure or uncontrolled hypertension that would preclude the use of modafinil.
    viii. No history of significant psychological disturbances
    ix. No drugs that are likely to interact with modafinil
    x. No evidence of current left cardiac failure.
    xi. Compliant with all standard COPD treatments including inhalers, nebulizers and theophyllines and steroids to optimize COPD care.
    E.4Principal exclusion criteria
    1. On NIPPV or CPAP
    2. Adverse reaction to modafinil
    3. Likely interaction of other drugs with modafinil
    4. Psychiatric illness/anxiety that maybe adversely affected my modafinil
    5. Hypercapnic respiratory failure only during an acute COPD exacerbation.
    6.A recognized coexisting respiratory disorder that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures.
    7.Epilepsy, significant psychological disorders, un-controlled hypertension, known significant liver or kidney disease.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in arterial gas abnormalities:- % reduction in PaCO2 reduction and % increase in PaO2 at 10 and 40 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    DaY 10 and day 40
    E.5.2Secondary end point(s)
    1 Improved Epworth sleepiness score
    2. Improved BODE scores.
    3. Any effect on the GAD-7 anxiety and depression score due to taking modafinil
    4. Lung function tests
    5. Oxygen saturation (day and night)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4 weeks before study start and at day 10 and day 40
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard care
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 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
    End of trial will be the last patient completing attendance at 40 days.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 60
    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)
    The treatment will stop at 40 days and we feel the benefit of the study needs to be assessed quickly and published so that beneficial findings can be extended to other patients with this condition and the "Drugs and therapeutics committee" may then feel they can approve its use in appropriate cases. To date our "Drugs and Therapeutics Committee" would like to see some further data as a randomised study....
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation St Helier Hospital
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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