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    Summary
    EudraCT Number:2006-000577-29
    Sponsor's Protocol Code Number:S187.3.001
    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:2006-10-12
    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 number2006-000577-29
    A.3Full title of the trial
    A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue to
    Experience Persistent Motor Fluctuations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects
    A.4.1Sponsor's protocol code numberS187.3.001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00357994
    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 Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)
    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 supportAbbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott 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+44 1628 644475
    B.5.5Fax number+44 1628 644330
    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 numberN° EU/3/01/035
    D.3 Description of the IMP
    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 name3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
    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 name(minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sinemet®25-100
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Capsule, hard
    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 INNLevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.3Other descriptive name3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 name(minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
    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) 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 placeboGel
    D.8.4Route of administration of the placeboGastroenteral use
    D.8 Placebo: 2
    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
    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 14.0
    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
    The primary objective of this study will be to demonstrate the superiority of treatment with Levodopa-Carbidopa Intestinal Gel (LCIG) over treatment with optimized oral Levodopa-Carbidopa during 12 weeks of treatment
    E.2.2Secondary objectives of the trial
    “On” time without troublesome dyskinesia (“On” time without dyskinesia or with non-troublesome dyskinesia)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with PD who experience motor complications despite optimized available therapy are eligible to participate and must also meet the following criteria in order to participate in this study.
    1. Diagnosis of idiopathic Parkinson’s disease according to the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria;
    2. The subject’s Parkinson’s disease is Levodopa-responsive and subjects must demonstrate some identifiable “On response”, as established through observation by the Investigator. Additionally, subjects will need to demonstrate severe motor fluctuations in spite of individually optimized treatment, and where other therapy should be considered.
    3. The subject’s history of anti PD therapy must include the following:
    •Must have demonstrated a significant response to Levodopa
    •Must have had an adequate trial of immediate-release Levodopa- decarboxylase inhibitor (e.g., Sinemet®) or controlled-release Levodopa-decarboxylase inhibitor (e.g., Sinemet®-CR) administered at a daily dose equivalent to a dose of ≥ 400 mg levodopa
    •Must have had an adequate trial of a dopaminergic agonist administered concomitantly with Levodopa-decarboxylase inhibitor
    •Must have had an adequate trial of a catechol O methyl transferase (COMT) inhibitor (i.e., entacapone or tolcapone) OR an adequate trial of a monoamine oxidase (MAO) –B inhibitor
    An “adequate trial” is defined as a therapeutic attempt in which the patient failed to achieve the therapeutic benefit for reason of either efficacy or tolerability. The patient must have:
    o Been treated for a minimum period of two weeks at a minimal dose of at least 33% of the maximally recommended dose in the approved label; or
    o Had to discontinue the drug either because of an adverse reaction or intolerability following the dosing regimen in the approved label.

    4. The presence of a recognizable “Off” and “On” state (motor fluctuations), as confirmed by the Parkinson’s Disease Diary recordings prior to the PEG-J procedure. Parkinson’s Disease Diaries are collected and evaluated prior to the PEG-J placement procedure.
    5. Subjects must be experiencing a minimum of three hours of “Off” time confirmed by the Parkinson’s Disease Diary for each of the three consecutive. The “Off” 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).
    6. Subject (or subject’s proxy/caregiver) must be able to complete both the Daily Dosing Diary and the Parkinson’s Disease Diary of “Off” time. The subject or caregiver must also be able to demonstrate the ability to operate, manipulate, and care for the infusion pump and tubing.
    7. Subject must demonstrate a 75% concordance with the Investigator’s or qualified designee’s assessment of symptoms on the Parkinson’s Disease Diary following training. Subject must also have a 75% or greater compliance rate on the diary completion to qualify for randomization.
    8. 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).
    9. Subjects must be able to speak, read, understand and possess the ability to respond to and follow simple instructions. For the subject to be eligible all required documents, including the informed consent, must be available in a language that is understandable to the subject
    10. Male or female subjects aged at least 30 years.
    11. Females who are not breast-feeding
    12. An independent physician attested that treatment with LCIG, including PEG-J placement, is suitable for the subject (Germany only).
    13. Female subjects of non-childbearing potential either postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Postmenopausal subjects should be amenorrheic for at least 24 months prior to Screening.
    14. Female subjects of childbearing potential practicing at least one of the following methods of birth control throughout the study:
    o Total abstinence from intercourse;
    o Vasectomized partner(s);
    o Intrauterine device (IUD);
    o Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal foam/gel/film/cream/suppository). Diaphragm must be used with spermicidal foam or jelly. The combination of diaphragm and spermicidal substance counts as a single barrier;
    o Using oral, injected, or implanted methods of hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration and the partner should also use a barrier method (e.g. condom) with spermicidal foam/gel/cream/suppository during this study and for 90 days after study drug completion.
    E.4Principal exclusion criteria
    Subjects meeting any of the exclusion criteria listed below either at screening and/or prior to randomization must be excluded from participation in the study.
    1. The PD diagnosis is unclear or a suspicion of other Parkinsonian syndromes exist, such as secondary Parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes (e.g., multiple system atrophy, progressive supranuclear palsy) or other neurodegenerative diseases.
    2. Subject has undergone neurosurgery for the treatment of PD.
    3. Current enrollment in another clinical study.
    4. Subjects with any neurological deficit that might interfere with the study assessments (e.g. hemiparesis); and/or any subjects who have had an acute stroke diagnosed within the six months prior to baseline.
    5. Known hypersensitivity to Levodopa, Carbidopa, or radiopaque material.
    6. Contraindications to levodopa, (e.g., narrow angle glaucoma, pheochromocytoma, Cushing’s syndrome or history of malignant melanoma).
    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 screening visit.
    8. Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, (e.g., bipolar disorder or major depressive disorder per (DSM-IV-TR criteria).
    9. Subject experiencing sleep attacks (see Section 11.3.2) or exhibiting clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality at any point during the three months prior to the screening evaluation).
    10. 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.
    11. Troublesome hallucinations not controlled by allowed concomitant therapy.
    12. Significant cognitive impairment that, in the opinion of the Investigator, would impact the subject’s ability to participate in the trial;
    o Mimi-Mental State Examination score of < 24
    o Alzheimer’s disease or other dementia
    13. Clinically significant abnormal laboratory data (e.g., alanine aminotransferase [SLT] or aspartate aminotransferase [AST] 3 x the upper limit of normal [ULN]), or any abnormal laboratory value that could interfere with the assessment of safety.
    14. 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).
    15. Subjects who in the judgment of the investigator would not be likely to complete the study.
    16. A history of, or a known current gastrointestinal, liver, kidney or other condition, which may interfere with the absorption, distribution, metabolism or excretion of the study drug, assessments or amy interfere with the insertion of the PEG-J tube (e.g., subjects who have undergone gastric or intestinal surgery other than appendectomy or cholecystectomy).
    17. Any malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin within the past five years prior to screening. Subjects with prostrate cancer or completely excised squamous cell carcinoma of the skin without reoccurrence within 2 years prior to Screening may be permitted to enroll following Investigator and Medical Monitor discussion and documentation of approval.
    18. Medical, laboratory, or surgical issues deemed by the investigator to be clinically significant.
    19. 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).
    20. Exposure to any investigational drug within 30 days prior to Study Day 1.
    21. Prior exposure to LCIG.
    22. Uncooperative attitude or reasonable likelihood for non-compliance with the protocol, study procedures or treatments.
    23. Site personnel and their immediate families defined as spouse, parent, child, grandparent or grandchild.
    24. Subject for whom the 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 evaluation. Contraindication for PEG-J tube placement includes but is 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 change from baseline in mean daily “Off” time (hours), based on the 3 consecutive day average of “Off” time for the Parkinson’s Disease Diary at Study Week 12 (endpoint). The Baseline value is defined as the values collected on the Parkinson’s Disease Diary before the PEG-J procedure
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Week 12
    E.5.2Secondary end point(s)
    o “On” time without troublesome dyskinesia (“On” time without dyskinesia or with non-troublesome dyskinesia)
    Other Secondary Variables:
    o PDQ-39
    o CGI-I
    o UPDRS Part II
    o UPDRS Part III
    o EQ-5D
    o Caregiver Burden (ZBI)
    All assessments related to the evaluation of Primary and Secondary Variables should be performed during the subject’s “On” time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Week 12
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Double-Dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned7
    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 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
    Germany
    United States
    E.8.7Trial has a data monitoring committee No
    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 months6
    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 months6
    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.1.1Number of subjects for this age range: 0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 31
    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)
    Patients who have completed the S187.3.001 trial will be eligible to participate in a one-year open-label study of levodopa-carbidopa intestinal gel extension study, (S187.3.003), provided that they have signed the informed consent form.
    For subjects who have completed their participation in the S187.3.001 and S187.3.003, LCIG may be provided outside of a study protocol but in accordance with all local regulations until their treatment can be reimbursed by the appropriate insurance system.
    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 Decision2006-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-20
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