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    Summary
    EudraCT Number:2015-004912-39
    Sponsor's Protocol Code Number:B7601003
    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:2016-02-11
    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 number2015-004912-39
    A.3Full title of the trial
    A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE
    EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE
    Eine 15‐wöchige Phase‐2, Doppelblinde, Randomisierte, Placebo‐kontrollierte Dosisfindungsstudie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit von PF‐06649751 In Patienten mit motorischen Fluktuationen aufgrund einer Parkinson‐Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 15-WEEK CLINICAL STUDY TO DETERMINE THE
    EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE
    Eine 15-wöchige klinische Studie die die Wirksamkeit, Sicherheit und Verträglichkeit von PF- 06649751 bei Patienten mit motorischen Schwankungen aufgrund der Parkinson-Erkrankung bestimmt
    A.4.1Sponsor's protocol code numberB7601003
    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.
    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 Kingdom
    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 pointGang Feng
    B.5.3 Address:
    B.5.3.1Street Address610 Main Street, 5th Floor
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1 857 777-6807
    B.5.5Fax number1 860 686-5921
    B.5.6E-mailgang.feng2@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.3.1Product namePF-06649751
    D.3.2Product code PF-06649751
    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 INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    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.3.1Product namePF-06649751
    D.3.2Product code PF-06649751
    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 INNPF-06649751
    D.3.9.2Current sponsor codePF-06649751
    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.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
    D.8 Placebo: 2
    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
    Parkinson Krankheit
    E.1.1.1Medical condition in easily understood language
    Gradually developing disorder of the nervous system that affects movement.
    Nach und nach Entwicklung der Störung des Nervensystems, die die Bewegung betrifft
    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 PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 effect on motor symptoms of PF-06649751 administered once daily as adjunctive treatment with stable doses of L-Dopa in Parkinson’s disease.
    - To determine the therapeutic window for motor symptom improvement of
    PF-06649751 administered once daily, ie, determining a dose, or a range of doses, for
    adequate control of motor symptoms.
    E.2.2Secondary objectives of the trial
    - To evaluate the dose-response on motor symptoms of PF-06649751 administered once daily in subjects with Parkinson’s disease.
    - To evaluate the safety and tolerability of PF-06649751 administered once daily in subjects with Parkinson’s disease.
    - To evaluate the effect of PF-06649751 administered once daily on dyskinesia in subjects with Parkinson’s disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical diagnosis of Parkinson’s disease consistent with the United Kingdom (UK) Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria.
    - Parkinson’s disease Hoehn & Yahr Stage less than or equal to III while the subject is ON.
    - Currently responding to L-Dopa therapy.
    - Total duration of 2.5 hours OFF time each day, based on the OFF time diary (Hauser diary) collected over 3 consecutive days during the screening period (with fewer than 4 errors or missing entries in diary data per day) and at least 75% concordance with investigator for Screening ON/OFF time concordance testing (see Concordance Testing and OFF Time Diary Training).
    - Subjects must be able to recognize their “wearing off” symptoms and confirm that they usually improve after their next dose of Parkinson’s disease medication.
    - On a stable dose of L-Dopa of at least 400 mg total daily dose for at least 28 days prior to Day 0 (Randomization), in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) divided in at least 4 doses per day. Subjects on a stable dose of L-Dopa of at least 400 mg/day divided into 3 daily doses (TID) may be considered and authorized on a case-by-case basis if submitted as part of the screening assessment to the sponsor and/or its designee for determination if the dosing regimen is considered optimized
    for that particular subject. No subject on TID dosing will be considered eligible for Randomization without this additional eligibility assessment.
    - Willing and able to refrain from any Parkinson’s disease medication not permitted by the protocol throughout participation in the study.
    - Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight 45 kg.
    - A score of 26 on the Mini Mental State Examination (MMSE).
    E.4Principal exclusion criteria
    - History or clinical features consistent with an atypical Parkinsonian syndrome.
    - History of surgical intervention for Parkinson’s disease (pallidotomy, thalamotomy, deep brain stimulation, etc).
    - A score of 4 on item 4.2 Functional Impact of Dyskinesias of MDS-UPDRS Part IV (motor complications) at Screening.
    - Psychotic symptoms related to Parkinson’s disease requiring treatment with an antipsychotic medication within 6 months prior to Screening.
    - Any Parkinson’s disease-related feature or symptom that could interfere with the study conduct and results as assessed by the sponsor or Investigator.
    - Severe acute or chronic medical, including fever, or psychiatric condition 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.
    - Presence or history of brain tumor, past history of hospitalization for head trauma with loss of consciousness, epilepsy (as defined by the
    International League Against Epilepsy), including childhood seizures, or conditions that lower seizure threshold, seizures of any etiology (including substance or drug
    withdrawal), or known increased risk of seizures.
    - A significant Axis I psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition- Revised (DSM IV-TR, American Psychiatric Association, 2000) that in the opinion of the investigator could interfere with study participation or poses a risk to the subject. Presence of minor depression or treated, stable depressive disorder is acceptable.
    - History of clinically significant alcohol or substance dependency (other than caffeine or nicotine), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), within 1 year before Screening.
    - In the opinion of the investigator (or caregiver, as applicable), has signs/symptoms suggestive of clinically significant cognitive impairment that would interfere with the ability to comply with study procedures.
    - Any condition possibly affecting drug absorption, past surgery of the gastrointestinal tract (eg, gastrectomy, colectomy), except cholecystectomy.
    - History of vasculitis.
    - History of Human immunodeficiency virus (HIV) infection.
    - History of malignancy (other than non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in situ that was surgically removed in total >1 year before screening and has not recurred). Other type of malignancy which has been in remission 5 years or more before screening and has not recurred.
    - Subjects with first degree family history of unexplained sudden death, or of Long QT syndrome (LQTS).
    - Currently receiving an antipsychotic, metoclopramide, reserpine, or amphetamine.
    - Currently receiving moderate or strong CYP3A4 inducers or CYP3A4 inhibitors (except for topical administration).
    - Previous implantation of apomorphine pump, or surgery for intraduodenal use of Duodopa.
    -Dopamine receptor agonist medications including pramipexole, ropinirole, rotigotine and apomorphine must be discontinued at least 28
    days prior to Day 0 (Randomization).
    -Herbal supplements must be discontinued at least 28 days prior to Day 0 (Randomization).
    E.5 End points
    E.5.1Primary end point(s)
    (Efficacy) Change from baseline in daily OFF time (hours OFF time; based on patient reported Hauser diary) at Week 10 (Day 70; end of Period A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 10
    E.5.2Secondary end point(s)
    (Efficacy; Evaluated during the entire double-blind period)
    Placebo corrected change from baseline in:
    - Daily OFF time (hours).
    - Daily ON time with troublesome dyskinesia (hours).
    - Daily ON time without troublesome dyskinesia (hours).
    - MDS - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III.
    - MDS-UPDRS Parts I, II, IV, and total score.

    Safety and Tolerability
    - Adverse events.
    - Clinical laboratory parameters.
    - Vital signs.
    - ECG parameters.
    - Columbia Suicide Severity Rating Scale (C-SSRS).
    - Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease – Rating
    Scale (QUIP-RS).
    - Physician Withdrawal Checklist (PWC-20).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy - Evaluated during the entire double-blind period
    Other endpoints - evaluated at the ends of Period A and B
    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 No
    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 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 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.8.2.4Number of treatment arms in the trial5
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    France
    Germany
    Japan
    Spain
    United Kingdom
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    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)
    None.
    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 FCRIN NS-Park Network
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Studienzentrale Kompetenznetz Parkinson, Klinik für Neurologie
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-10
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