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    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-000128-81
    Sponsor's Protocol Code Number:B7601017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-000128-81
    A.3Full title of the trial
    PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH
    MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH
    MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE
    A.4.1Sponsor's protocol code numberB7601017
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, New York
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800 7181021
    B.5.5Fax number+1 303 7391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.com
    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 PF-06649751 - 1mg
    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 INNNot yet assigned
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.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 PF-06649751 - 5mg
    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 INNNot yet assigned
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 PF-06649751 - 15mg
    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 INNNot yet assigned
    D.3.9.3Other descriptive namePF-06649751
    D.3.9.4EV Substance CodeSUB178413
    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) 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
    D.8.3Pharmaceutical form of the placeboTablet
    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
    E.1.1.1Medical condition in easily understood language
    Parkinson’s disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000014025
    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 long-term safety and tolerability of PF-06649751 administered once daily (QD) in subjects with Parkinson’s disease (PD).
    E.2.2Secondary objectives of the trial
    To evaluate the long-term effect on motor symptoms of PF-06649751 administered QD in subjects with PD.
    To evaluate steady state PF-06649751 concentrations following administration of PF-06649751 QD in subjects with PD.
    To evaluate the long-term effect of PF-06649751 administered QD on other non-motor domains relevant in PD.
    After Wk 5, the investigator will have the option to attempt a reduction of L-Dopa, after a discussion with the Sponsor, if considered appropriate:
    To evaluate the reduction of L-Dopa dose while used concomitantly with daily PF-06649751 in subjects with PD.
    For those subjects who participate in the Relative Bioavailability Sub-study: To evaluate the relative bioavailability of two different formulations of PF-06649751.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Relative Bioavailability Study (rBA)-version 31 March 2017

    To investigate PF-06649751 pharmacokinetics and relative bioavailability at steady state from immediate release (IR) tablet of PF-06649751 (1 x 15 mg) relative to currently used IR tablet (3 x 5 mg) following oral administration.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study at Screening.
    2. Subjects must have successfully completed the B7601003 study through Wk 15,continue to meet all safety criteria at Screening and through Randomization visit, and must be considered compliant in the opinion of the investigator and the Sponsor.
    3. No change since B7601003 study in any significant medical, rheumatologic, oncologic, neurologic, psychiatric or surgical conditions that are deemed to increase risk for participation in the extension study.
    4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, including Parkinson’s disease diary.
    5. Subjects are willing and able to continue to refrain from any medication not permitted by the protocol throughout participation in the study.
    6. Subjects successfully completed study B7601003 through Wk 15, with an IP dosing gap of no more than 60 days between the 2 studies.
    7. Females of non-childbearing potential and/or male subjects between the ages of 40 and 87 years, inclusive. Male subjects able to father children must agree to use 1 highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
    Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    Have medically confirmed ovarian failure; or
    Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state.
    All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential and are not eligible for participation.
    8. Subjects must still be able to recognize their “wearing off” symptoms and confirm that they usually improve after their next dose of PD medication.
    E.4Principal exclusion criteria
    Subjects with any of the following characteristics/conditions will not be included in the study:
    Concomitant Medications:
    1.Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine.
    2.Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
    3.Previous implantation of apomorphine pump, or surgery for intraduodenal use of Duodopa.
    4.Dopamine receptor agonist medications including pramipexole, ropinirole, rotigotine and apomorphine taken within 60 days prior to Day - 1.
    5.Herbal supplements taken within 28 days prior to Day -1 (Herbal supplements defined as concentrated/manufactured capsules or tablets).
    6.Prohibited concomitant medications as outlined in Section 5.8, Concomitant Treatment(s) and in the Prohibited Concomitant Medication List.
    Screening Assessments:
    7. 12-lead ECG (average of triplicate measures) demonstrating QTcF >450 msec (>470 msec for females) or a QRS interval >120 msec at Screening.
    General and Administrative:
    8. Subjects who would have a gap of more than 60 days between their last IP dose in Study B7601003 and their first dose in Study B7601017.
    9. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    10. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Day-1.
    11. Unwilling or unable to comply with the lifestyle requirements described in the protocol.
    Medical History:
    12. Emergence of severe acute or chronic medical condition, or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    Screening Assessments:
    13. Females of childbearing potential assessed at Screening; Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; fertile male subjects who are unwilling or unable to use 1 highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
    14. Finding of suicidal ideation associated with actual intent and/or plan in the past year; (a “YES” answer to C-SSRS questions 4 “some intent to act without specific plan” or 5 “specific plan and intent”) not cleared by a mental health professional evaluation.
    15. Screening supine blood pressure ≥160 mm Hg (systolic) or ≥95 mm Hg (diastolic), on a single measurement. If abnormal, up to 2 repeats are permitted following at least 5 minutes of rest. The screening value in that case will be the average of the 2 values closest to the normal range.
    16. A decrease in systolic blood pressure (BP) of >20 mmHg or in diastolic BP of >10 mmHg measured 2 minutes after changing from a supine to standing position in the presence of symptoms of orthostasis. In the absence of symptoms of orthostasis a decrease in systolic blood pressure (BP) of >30 mmHg or in diastolic BP of >15 mmHg measured 2 minutes after changing from a supine to standing position (the mean of three independent sets of vital signs, taken at least 15 minutes apart at the screening visit, will determine eligibility).
    17.A positive urine drug screen for drugs of abuse unless explained by a medically indicated medication.
    18.Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:
    •Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transminase (SGOT) or alanine aminotransferase (ALT)/serum glutamic pyruvic transminase (SGPT) ≥2x upper limit of normal (ULN);
    •Total bilirubin ≥1.5 x ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ULN.
    19. Subjects with clinically significant depression: Patient Health Questionnaire 8 (PHQ 8) total score ≥15 [for Delayed Rollover Subjects ONLY].
    General and Administrative:
    20. Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 60 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication (whichever is longer) other than the B7601003 parent study.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events
    Physical and neurological exam findings
    Clinical laboratory parameters
    Vital signs
    Electrocardiogram (ECG) parameters
    Columbia Suicidality Severity Rating Scale (C-SSRS).
    Physician Withdrawal Checklist (PWC-20).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study
    E.5.2Secondary end point(s)
    Exploratory endpoints

    Daily OFF time (hours).
    Daily ON time with troublesome dyskinesia (hours).
    Daily ON time without troublesome dyskinesia (hours).
    Movement Disorder Society-Universal Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and total score.
    Steady state plasma concentrations of PF-06649751.
    Relation between PF-06649751 plasma exposures and relevant study endpoints.
    EuroQol 5 Dimension (EQ-5D-5L).
    Patient Global Impression-Severity (PGI-S).
    For subjects who attempted to reduce L-Dopa after Wk 5:
    % reduction in total daily L-Dopa dose.
    Number of subjects with≥25,≥50%,≥75% and with 100% reduction in daily L-Dopa dose.

    For those subjects who participate in the Relative Bioavailability Sub-study:
    Steady-state area Under the Curve from time 0 to 12 hours (AUC0-12), maximum concentration (Cmax), trough concentration (Ctrough) and time at maximum concentration (Tmax) on Visit 5 and Visit 6 in relative bioavailability (rBA) sub-study participants.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    Spain
    United States
    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
    For this study, the End of trial in European Union (EU) Member States is defined as Last Subject Last Visit (LSLV) based on the total of randomized subjects in accordance with the protocol.
    End of trial in all other participating countries is defined as last subject last visit (LSLV).
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 198
    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 subject will return to their regular physician/neurologist after completion of the 12 month open label study.
    There are no plans at this time for a prolongation of this open label study. This may be revisited by the sponsor in the event of a positive readout for the Phase 2 study B7601003.
    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 Decision2017-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-24
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