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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41188   clinical trials with a EudraCT protocol, of which   6742   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) .
     
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    Summary
    EudraCT Number:2006-003490-27
    Sponsor's Protocol Code Number:204PD202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-09-29
    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 number2006-003490-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa
    A.4.1Sponsor's protocol code number204PD202
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number12870393
    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 SponsorBIOGEN IDEC 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.3.2Product code BIIB014
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 442908-10-3
    D.3.9.2Current sponsor codeBIIB014
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.3.2Product code BIIB014
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 442908-10-3
    D.3.9.2Current sponsor codeBIIB014
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 3
    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.3.2Product code BIIB014
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 442908-10-3
    D.3.9.2Current sponsor codeBIIB014
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Parkinson's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess the preliminary safety and tolerability of single and multiple oral doses of BIIB014 when administered as adjunct therapy in subjects with moderate to late-stage PD who are also receiving L-DOPA.
    E.2.2Secondary objectives of the trial
    1. To explore the PK of BIIB014 and its N-acetyl metabilite when administered as adjunct therapy to subjects with moderate to late-stage PD.
    2. To explore the activity of BIIB014 when administered as adjunct therapy to subjects with moderate to late-stage PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the Day 1 Visit:
    1. Must give written informed consent and any authorizations required by local law.
    2. Must be at least 30 years old at the time of informed consent.
    3. Must carry a diagnosis of idiopathic PD according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria.
    4. Must be on a stable dose of L-DOPA in conjunction with a dopa-decarboxylase inhibitor (e.g., L-DOPA/carbidopa or L-DOPA/benserazide) administered at least 3 times per day for at least 4 weeks prior to the Day 1 Visit. Subjects must be willing and able to continue on this L-DOPA regimen throughout their participation in the study.
    5. Subjects taking dopaminergic therapies allowed by the protocol must have been on a stable dose for at least 4 weeks prior to the Day 1 Visit and must be willing and able to continue their regimen throughout their participation in the study.
    6. Except for L-DOPA and allowed dopaminergic therapies, subjects must be willing and able to refrain from any other PD medication not permitted by the protocol throughout their participation in the study.
    7. Must be Hoehn & Yahr Stage II-IV inclusive when OFF.
    8. Subjects enrolled into Part B must have definite end of L-DOPA dose wearing OFF (at least 2 hours of OFF time per waking day confirmed by the subject’s Hauser Patient Diary).
    9. Subjects enrolled into Part B must demonstrate the ability to keep accurate Hauser Patient Diaries of PD activity prior to randomization: at least 80% concordance between subject and Investigator/Trainer diary ratings (comparing OFF time, ON time without dyskinesias, and ON time with dyskinesias [troublesome or non-troublesome]) must be achieved during a diary training session. Subjects must have at least one transition from OFF to ON or from ON to OFF during the training session(s). Subjects must be willing and able to complete adequate Hauser Patient Diaries throughout the study period.
    10. Subjects enrolled into Part B must provide a valid Hauser Patient Diary, defined as containing no more than 4 missing or duplicative entries per day for Days –3, -2, and –1, at the Day 1 Visit.
    11. Male and female subjects of child-bearing potential must be willing to practice effective birth control for the duration of the study. Female subjects must be: (1) postmenopausal for at least 12 months, (2) surgically sterile (i.e., no uterus or no ovaries; females who have tubal ligation [tubes tied or cut] are not considered surgically sterile), or (3) willing to use 2 acceptable forms of birth control (i.e., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide). Male subjects with partners of child-bearing potential must use barrier contraception in addition to a second method of contraception used by their female partners. Male subjects should be advised to abstain from sexual intercourse with pregnant women or use condoms. Male and female subjects must be willing and able to continue contraception for 2 months after their last dose of study treatment. Female subjects of childbearing potential must have a negative pregnancy test result at both the Screening Visit and the Day 1 Visit.
    E.4Principal exclusion criteria
    Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Day 1 Visit:
    1. Has a Mini Mental State Examination score <26.
    2. History or clinical features consistent with an atypical parkinsonian syndrome.
    3. Any significant non-PD central nervous system disorder.
    4. Any significant AXIS I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition-Revised.
    5. History of surgical intervention for PD.
    6. History of malignancy unless an exemption has been granted.
    7. History of severe allergic or anaphylactic reactions to any drug.
    8. History of human immunodeficiency virus.
    9. Hb A1c >7.0% at the Screening Visit.
    10. Abnormal laboratory results from the Screening Visit in a quantitative test of G6PD activity or evidence of G6PD deficiency in any qualitative test (unless subsequent quantitative testing confirms activity within the normal range). Subjects with a family history of G6PD deficiency, subjects with immediate family members diagnosed with sickle cell anaemia or deaths due to neonaal jaundice, or subjects with a past history of hemolytic anemia or severe hemolysis are also to be excluded from the study.
    11. Clinically significant hypertension, cardiac, gastrointestinal, renal, pulmonary, hematopoietic, endochrine, hepatic, immunologic, metabolic, urologic, dermatologic, and/or other major disease, unless an exemption has been granted.
    12. Serious infection within 1 month prior to Day 1.
    13. Positive for hepatitis C antibody or hepatitis B surface antigen.
    14. Abnormal laboratory results from the Screening Visit as follows: aspartate aminotransferase, alanine aminotransferase, total bilirubin, gammaglutamyl-transferase levels >1.5 x ULN; serum lipase >ULN; white blood cell count <4,000 cells/mm3; hemoglobin <10 g/dL, or any other abnormal laboratory value that could interfere with the assessment of safety.
    15. Clinically significant baseline ECG or laboratory abnormalities, unless exempted.
    16. Orthostatic hypotension as defined by a decrease in systolic BP of >20 mmHg or in diastolic BP of >10 mmHg measured 2 minutes after changing from a supine to standing position.
    17. For subjects receiving treatment with non-centrally acting anti-hypertensive agents, any change in dosing regimen within the 3 months prior to Day 1.
    18. Participation in any other investigational drug study within the 4 weeks prior to Day 1 or within 5 half-lives of the investigational treatment, whichever is longer.
    19. Treatment with any disallowed PD medication, centrally acting dopaminergic antagonists, or any change in L-DOPA or dopaminergic therapy dosing within the 4 weeks prior to Day 1.
    20. For subjects receiving concomitant treatment with allowed dopaminergic therapies:
    . Within the 4 weeks prior to Day 1: Any change in dosing (dose and/or frequency) of any 2D6 substrate (antidepressants or opioid narcotics)
    · Within the 2 weeks prior to Day 1: Treatment with any known CYP inhibitors
    21. Use of estrogen-containing depot or intrauterine contraceptives or second-generation estrogen-containing oral contraceptives within the 4 weeks prior to Day 1 or at any time during the study.
    22. Any change in dosing regimen within the 4 weeks prior to Day 1 for any of the following:
    . any central nervous system active therapy
    · maintenance or prophylactic therapy for stable medical conditions,
    · contraceptives,
    · approved over-the-counter medications, and/or
    · alternative health preparations and procedures.
    23. Female subjects who are pregnant or are planning to become pregnant within the next 6 months following study entry, or who are currently breastfeeding.
    24. History of drug or alcohol abuse as defined by the DSM IV-TR within 1 year prior to randomization into this trial.
    25. Donation of blood or plasma in excess of 500 mL within 3 months of Day 1.
    26. Caffeine intake within the 24 hours prior to Day 1.
    27. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition that is likely to affect the subject’s ability to comply with the protocol.
    28. Any other reasons that, in the opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are:
    · The number and proportion of subjects with AEs.
    · Assessment of clinical laboratory parameters.
    · Assessment of vital signs.
    · Assessment of ECG parameters.
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    DOSE ESCALATION
    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 concerned5
    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 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
    DATABASE LOCK:
    This is the End of Study definition being used routinely by Biogen Idec.
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 137
    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 Decision2006-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-03
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