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    Summary
    EudraCT Number:2006-005186-18
    Sponsor's Protocol Code Number:S187.3.004
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-13
    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 number2006-005186-18
    A.3Full title of the trial
    “An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s Disease
    A.4.1Sponsor's protocol code numberS187.3.004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00335153
    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 SponsorAbbott Healthcare Products B.V.
    B.1.3.4CountryNetherlands
    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 supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+331628644475
    B.5.5Fax number+331628644330
    B.5.6E-maileuclinicaltrials@abbott.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 Yes
    D.2.1.1.1Trade name DUODOPA®Intestinal Gel
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Products GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/01/035
    D.3 Description of the IMP
    D.3.1Product nameDuodopa
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.3Other descriptive namePhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarbidopa Monohydrate
    D.3.9.1CAS number 38821-49-7
    D.3.9.3Other descriptive namePhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
    E.1.1.1Medical condition in easily understood language
    Advanced 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the longterm safety and tolerability of LCIG over 12 months in subjects with advanced levodopa-responsive PD and severe motor-fluctuations despite optimized treatment with available PD medications.
    E.2.2Secondary objectives of the trial
    A secondary objective will be to assess the long-term maintenance of efficacy and health-related outcome measures as measured by change from Baseline to Endpoint using the following assessments:
    ● "Off" time as measured by the Parkinson's Disease Diary©14
    ● "On" time without troublesome dyskinesia as measured by the Parkinson's
    Disease Diary©
    ● Parkinson's Disease Diary©
    ● UPDRS Parts I, II, III, and IV
    ● CGI-I
    ● PDQ-39
    ● EQ-5D
    ● Caregiver burden (ZBI)
    ● Emp I and Emp II
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria;.
    2. The subjects' advanced PD must be the Levodopalevodopa-responsive type as judged by the Investigator. Additionally, subjects will need to demonstrate severe motor fluctuations in spite of individually optimized available treatment, and where other therapy options are indicated;.
    3. Subjects have had optimal treatment with available PD medication as defined by local standards of care and, based upon the judgment of the Investigator, and their symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of Levodopalevodopa and/or other antiparkinsonian medication; this. This will be based on the Investigator's best clinical judgment;.
    4. Presence of a recognizable "offOff" and "onOn" state (motor fluctuations) as confirmed by the symptom diaryParkinson's Disease Diary© at baseline (diaries are collected for the 3 days preceding the Baseline visit);.
    5. Subjects (or subject's proxy) must be able to keep a subject diaryParkinson's Disease Diary© of "offOff" time and dyskinesia;. Subjects' entries may be entered by the caregiver.
    6. Subjects must be experiencing a minimum of 3 hours per day of "offOff" time, as estimated by the Investigator and supported by the UPDRS and the diariesParkinson's Disease Diary©. The "offOff" time must occur during a continuous 16-hour interval, including the portion of the day during which the subject is awake the majority of the time (e.g., 5 AM to 9 PM, 7 AM to 11 PM);.
    7. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen);.
    8. Subjects must be able to speak, read, understand and possess the ability to respond to and follow simple instructions. For a subject to be eligible all required documents, including the informed consent, must be available in a language which is understandable to the subject;.
    9. Male or female subjects aged at least 30 years; of age.
    10. Females who are not breast-feeding or are of non-childbearing potential. All females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) test prior to study entry.
    Non-childbearing is defined as:
    ● last natural menstruation at least 24 months prior to Baseline or
    ● surgically sterilized (i.e., tubal sterilization) at least 3 months prior to Baseline or
    ● total hysterectomy at least 3 months prior to Baseline.
    11. A female subject of childbearing potential may be enrolled provided that she is maintained on one of the following medically acceptable methods of birth control (a stable dose of contraceptive drug for at least 3 months or barrier methods: intra uterine device, diaphragm, combination of a condom and spermicide).

    E.4Principal exclusion criteria
    Subjects meeting any of the exclusion criteria listed below either at screening and/or baseline must be excluded from participation in the study.
    1. PD diagnosis is unclear or a suspicion of other parkinsonianParkinsonian syndromes exists, such as secondary parkinsonismParkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson's-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or other neurodegenerative diseases;.
    2. Subjects who have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation);.
    3. Subjects with any neurological deficit that might interfere with the study assessments (e.g., hemiparesis); and/or any subjects diagnosed with an acute stroke within the 6 months prior to Baseline;.
    4. Known hypersensitivity to Levodopa, Carbidopalevodopa, carbidopa or radiopaque material;.
    5. Contraindications to Levodopa,levodopa such as narrow angle glaucoma, pheochromocytoma, Cushing's syndrome andor history of malignant melanoma;.
    6. Subjects who are experiencing sleep attacks or who exhibit clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the 3 months prior to the screening evaluation;.
    7. Current diagnosis or history of drug or alcohol abuse (Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria) within 12 months prior to the Screening visit;.
    8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses (e.g., such as bipolar disorder or major depressive disorder (per DSM IV-TR criteria);.
    9. Psychiatric, neurological or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct or interpretation of the study; troublesome. Troublesome hallucinations would also be included under this category;.
    10. Alzheimer's disease; or other conditions including significant cognitive impairment or dementia (defined as MMSE < 24);.
    11. Clinically significant abnormal laboratory data (e.g., aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥ 3 × ULN) or any other abnormal laboratory value that could interfere with the assessment of safety. in the judgment of the Investigator;.
    12. Current evidence of clinically significant hematological, autoimmune, endocrine, cardiovascular, renal or gastrointestinal disorder that would possibly interfere with the subject's participation in the study (e.g., treated, controlled and thus stable hypertension is not considered an exclusion criterion);.
    13. A history of, or a known current gastrointestinal, liver, kidney or other known condition, which may interfere with the absorption, distribution, metabolism or excretion of the study drug and/or assessments, or interfere with the insertion of the tubing system (e.g., subjects who have undergone gastric or intestinal surgery other than, for instance, appendectomy or cholecystectomy);.
    14. Any malignant disease or a history of neoplasms, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past 5 years prior to screening. Additionally, subjects with prostate cancer may be considered for enrollment in the study following a comprehensive assessment and a discussion between the Investigator and the Medical Monitor regarding the appropriateness of the subject for the study;.
    15. Medical, laboratory or surgical issues deemed by the Investigator to be clinically significant;.
    16. A planned surgical procedure scheduled for when a subject would be participating in the study (subjects may later be considered for inclusion following full recuperation from the surgical procedure);.
    17. Exposure to any investigational drug within 30 days prior to Baseline (Visit 2);.
    18. Prior exposure to LCIG;.
    19. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol;, study procedures or treatments.
    20. Site personnel and their immediate families defined as spouse, parent, child, grandparent or grandchild;.
    21. Subjects who will not provide written informed consent for participation in the study;.
    22. Subjects for whom placement of a PEG-J tube for LCIG treatment is contraindicated, or that the subject would be considered a high risk for the PEG-J procedure according to the Gastroenterologist's/Surgeongastroenterologist's/surgeon's evaluation. Contraindications for PEG-J tube placement include, but are not limited to, the following conditions: e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, and paralytic ileus.
    E.5 End points
    E.5.1Primary end point(s)
    The safety and tolerability of LCIG will be assessed by the following assessments:
    ● Physical examination, including weight
    ● Vital signs (systolic/diastolic blood pressure, pulse rate and temperature), including orthostatic vital signs (supine and standing [after 2 minutes])
    ● Neurological Examination
    ● Clinical laboratory assessments including biochemistry, hematology and, urinalysis, thyroid function studies and special labs to monitor for vitamin deficiency
    ● Resting 12-lead electrocardiograms (ECGs)
    ● Concomitant medication usage
    ● Adverse event monitoring (including the development of sleep attacks, for the development of melanoma, or excessive impulsive behavior)
    ● Abnormal Involuntary Movement Scale (AIMS)
    ● Monitoring complications of the infusion device
    ● Tolerability assessed by number of subjects who complete the study in each group.

    The pharmacokinetic objectives are to estimate the population mean values of pharmacokinetic parameters of Levodopalevodopa following administration of LCIG in subjects with PD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    ●"Off" time as measured by the Parkinson's Disease Diary©14
    ● "On" time without troublesome dyskinesia as measured by the Parkinson's
    Disease Diary©
    ● Parkinson's Disease Diary©
    ● UPDRS Parts I, II, III, and IV
    ● CGI-I
    ● PDQ-39
    ● EQ-5D
    ● Caregiver burden (ZBI)
    ● Emp I and Emp II

    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    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 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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Australia
    Canada
    Czech Republic
    Finland
    Germany
    Israel
    Italy
    Netherlands
    New Zealand
    Poland
    Portugal
    Russian Federation
    Spain
    Thailand
    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
    Last patient last vist
    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 years5
    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.1.2.1Number of subjects for this age range: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 320
    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)
    Subjects will transfer to follow-up study S187.3.005
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-20
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