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    The EU Clinical Trials Register currently displays   41210   clinical trials with a EudraCT protocol, of which   6750   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2009-013885-14
    Sponsor's Protocol Code Number:P06-10/BF2.649
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-09-23
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-013885-14
    A.3Full title of the trial
    A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.

    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.
    A.4.1Sponsor's protocol code numberP06-10/BF2.649
    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 SponsorBIOPROJET
    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.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 namePitolisant
    D.3.2Product code BF2.649
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPitolisant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Excessive daytime sleepiness in Parkinson?s Disease

    Somnolencia diurna excesiva en la enfermedad de Parkinson.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10015595
    E.1.2Term Excessive daytime sleepiness
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level HLT
    E.1.2Classification code 10034005
    E.1.2Term Parkinson's disease and parkinsonism
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of BF2.649 over placebo (Double-Blind Phase) and assess the long term efficacy (Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness, as measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and confirm the long-term efficacy at Week 51, in patients diagnosed with Parkinson?s Disease
    E.2.2Secondary objectives of the trial
    To evaluate diurnal somnolence and sleep episodes number and duration as reported in the patients? sleep diaries
    To assess the evolution of the Fatigue Severity Scale Scores (FSS)
    To evaluate the evolution of the Unified Parkinson Disease Rating Scale (UPDRS)
    To assess Quality of Life of Patients reported in Parkinson Disease Questionnaire (PDQ-39)
    To assess dopamine agonists dosage modification
    To assess the evolution of the Clinical Global Impression on EDS as measured by the CGI scale scores.
    To assess patients? depression as measured by the Beck Depression Inventory (BDI) score
    To assess Patients? Apathy as measured by the Apathy Evaluation Scale (AES)
    To assess the product withdrawal effect at W13 and W52 by collecting the changes in signs and symptoms (increased appetite, increased sleepiness, excitability, changes in mood)and by assessing the modification of ESS, AES, FSS, PDQ-39, CGI , BDI and sleep diary after one week of product withdrawal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Outpatients, male or female, aged between 30 to 80 years
    Patients with a documented history of Parkinson?s disease according to UPDRS (Unified Parkinson Disease Rating Scale), fluctuator and non-fluctuator patients, Hoehn and Yahr score <5
    Patients stabilized on optimal antiparkinsonian treatments unmodified for 8 weeks prior to study entry
    Patients presenting an Excessive Daytime Sleepiness as indicated by an Epworth Scale Score ³12
    Patients having a health Insurance Coverage (according to local regulatory requirements)
    Patients having signed an informed consent before any specific study procedures.
    E.4Principal exclusion criteria
    Known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy?s Body dementia)
    Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
    Severe depression indicated by Beck?s Depression Inventory (BDI ³16) or at suicidal risk (BDI item 9>0) or depression treated for less than 8 weeks
    Cognitive impairment as indicated by a Minimental Status Examination (MMSE) score less than 25 or with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study
    Females who have not been using an adequate contraceptive method for the last 2 months, or is pregnant or breastfeeding, or not at least one year post-menopausal or unwilling or unable to continue contraceptive use during the study
    Recent history of alcohol or drug abuse within the last three years prior to study entry
    Concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult or which could interfere with the study conduct or contra-indicate the study treatments or put patients at risk
    Progressively fatal disease, or life expectancy ? one year
    Known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), QTc strictly higher than 450 ms (electrocardiogram Bazett?s corrected QT interval ( QT / ?[60/HR])
    Patients who have received any other investigational drug (including BF2.649) within 1 month prior to study entry, or have such treatment planned during the study period
    Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study
    Suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication
    Galactose intolerance, lactase deficiency or glucose-galactose malabsorption
    Associated treatments which are not allowed during the study course and which cannot be stopped at least 2weeks prior to study entry
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of the Epworth Sleepiness Scale scores (ESS). Comparison between the ESS score baseline value and the ESS-score at week 12 and week 51
    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 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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Yes
    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 months2
    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 months2
    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) Yes
    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 state99
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 246
    F.4.2.2In the whole clinical trial 246
    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 Decision2009-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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