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    The EU Clinical Trials Register currently displays   44238   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-003738-24
    Sponsor's Protocol Code Number:ADS-AMT-PD304
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-01
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-003738-24
    A.3Full title of the trial
    ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease
    A.3.2Name or abbreviated title of the trial where available
    EASE LID 3 STUDY
    A.4.1Sponsor's protocol code numberADS-AMT-PD304
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02136914
    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 SponsorAdamas Pharmaceuticals, 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 supportAdamas Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdamas Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1900 Powell Street, Suite 750
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post codeCA 94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number001510 450 3500
    B.5.5Fax number001510 428 0519
    B.5.6E-mailclinicaltrials@adamaspharma.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 nameAmantadine HCl Extended Release Capsule
    D.3.2Product code ADS-5102
    D.3.4Pharmaceutical form Prolonged-release 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 INNAmantadine hydrochloride (HCl)
    D.3.9.1CAS number 665-66-7
    D.3.9.3Other descriptive nameAMANTADINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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 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-induced dyskinesia in subjects with Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Treatment of drug induced abnormal movements in 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 17.1
    E.1.2Level PT
    E.1.2Classification code 10013916
    E.1.2Term Dyskinesia
    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 efficacy of ADS-5102 oral capsules, an extended release formulation of amantadine, at a dose level of 340 mg, dosed once nightly at bedtime for 13 weeks, for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson’s disease (PD).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ADS-5102 in this study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed a current IRB/REC/IEC-approved informed consent form;
    2. Male or female subjects between 30 and 85 years of age, inclusive;
    3. Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments;
    4. Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to study visits and assist in completion of study instruments, as needed and allowed;
    5. Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (trained caregiver/study partner assistance allowed);
    6. Parkinson’s disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria;
    7. On a stable regimen of antiparkinson’s medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation;
    8. A score of at least 2 on part IV, item 4.2 (functional impact of dyskinesias) of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), at screening and at Baseline/Day 1/Week 0;
    9. Using the 48-hour PD home diaries completed just prior to Baseline/Day 1/Week 0 (baseline), at least 2 half-hour time periods between 9 am and 4 pm of each 24-hour period are indicated as “ON with troublesome dyskinesia”;
    10. Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis);
    11. If taking an antidepressant, must be on a stable dose for at least 30 days prior to randomization.
    E.4Principal exclusion criteria
    1. History of exclusively diphasic, off state, myoclonic, dystonic, or akathetic dyskinesia without peak dose dyskinesia;
    2. History of neurosurgical intervention related to PD (e.g. deep brain stimulation);
    3. History of other neurological disease that, in the opinion of the investigator, would affect motor function or cognition, including, but not limited to Alzheimer’s dementia, Huntington’s disease, Lewy body dementia, frontotemporal dementia, corticobasal degeneration, progressive supranuclear palsy, multiple system atrophy, motor or sensory dysfunction secondary to stroke or brain trauma, or multi-infarct dementia with lacunae;
    4. History of clinically significant hallucinations (visual, auditory, or any other type) due to levodopa, dopamine agonist, underlying PD or other/unknown cause, within 1 year prior to screening;
    5. History of sensory impairments (e.g., hearing, vision) that, in the opinion of the investigator, would impair the subject’s ability to complete study assessments or presence of untreated angle closure glaucoma;
    6. History of alcohol or substance dependence or abuse within 2 years prior to screening;
    7. History of seizures within 2 years prior to screening;
    8. History of stroke or TIA within 2 years prior to screening;
    9. History of myocardial infarction, or NYHA Functional Classification of Heart Failure Class 3 or 4 within 2 years prior to screening;
    10. Any clinically significant ECG abnormalities, including any findings of abnormal ventricular conduction or rhythm other than isolated PVCs or first degree AV block;
    11. History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated cancer that is considered cured;
    12. Presence of cognitive impairment, as evidenced by a MMSE score of less than 24 during screening;
    13. Hoehn and Yahr Stage 5;
    14. Presence of an acute or chronic major psychiatric disorder or symptom (e.g. suicide ideation) that, in the opinion of the investigator, would affect the subject’s ability to complete study assessments, or which would not be in the subject’s best interest to participate in the study;
    15. Presence of orthostatic hypotension at screening: a decrease in systolic blood pressure (at least 20 mm Hg) or diastolic blood pressure (at least 10 mm Hg) within 3 minutes of the subject standing up, compared to pressures obtained while sitting;
    16. Any of the following:
     Hemoglobin < 10 g/dL
     WBC <3.0 x 1e9/L
     Neutrophils <1.5 x 1e9/L
     Lymphocytes < 0.5 x 1e9/L
     Platelets <100 x 1e9/L
     AST and/or ALT > 2 times the upper limit of normal;
    17. Estimated GFR < 50 mL/min/1.73m2 (calculated using MDRD);
    18. Inability to swallow oral capsules, or a history of gastrointestinal malabsorption that would preclude the use of oral medication;
    19. If female, is pregnant or lactating;
    20. If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an IUD, or vasectomized male partner is also acceptable), in combination with a barrier method, from screening through at least 4 weeks after the completion of study treatment;
    21.Use of amantadine within 30 days prior to screening, or documented inability to tolerate amantadine, history of suicide ideation or suicide attempt during prior amantadine use, or lack of response to prior amantadine treatment for LID;
    22.Use of rimantadine for influenza prophylaxis within 30 days prior to screening;
    23.History of hypersensitivity or allergic reaction to amantadine, rimantadine, or memantine,or to any of the excipients used in the study medication capsules;
    24.Received live attenuated influenza vaccine within 2 weeks prior to randomization(amantadine may interfere with the efficacy of live attenuated vaccine);
    25.Current treatment with medications that may affect the renal clearance of amantadine: carbonic anhydrase inhibitors, sodium bicarbonate, or urinary acidificationagents, quinine, quinidine, triamterene, or trimethoprim;
    26.Current treatment with apomorphine, mucuna pruriens, topiramate, or metoclopramide.Subjects who are able to appropriately discontinue these agents at least 30 days prior toscreening will be eligible for screening;
    27.Current treatment with medications that act primarily by blocking dopamine receptors. Subjects who are able to appropriately discontinue these agents at least 60 days prior to screening will be eligible for screening;
    28.Treatment with an investigational drug or device within 30 days prior to screening;
    29.Treatment with an investigational biologic within 6 months prior to screening;
    30.Current participation in another clinical trial;
    31.Prior participation in the ADS-PAR-AM201 or ADS-AMT-PD301;
    32.Planned elective surgery during study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the change from baseline to Week 12 in the Unified Dyskinesia Rating Scale (UDysRS) total score. This scale has four parts, and a total possible score of 104:
    I. Historical Disability (patient perceptions) of On-Dyskinesia impact
    II. Historical Disability (patient perceptions) of Off-Dystonia impact
    III. Objective Impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities)
    IV. Objective Disability based on Part III activities
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome measure is the change from baseline to Week 12
    E.5.2Secondary end point(s)
    Key Secondary Outcome Measures:
    Change from baseline to Week 12 in each of the following:
     ON time without troublesome dyskinesia (ON time without dyskinesia plus ON time with non-troublesome dyskinesia), based on a standardized PD home diary
     OFF time, based on a standardized PD home diary

    Other Secondary Outcome Measures:
    Change from baseline to Week 12 in each of the following:
     ON time with troublesome dyskinesia, based on a standardized PD home diary
     Total time with dyskinesia (non-troublesome and troublesome), based on a standardized PD home diary
     Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV, item 4.1 (time spent with dyskinesias), and Part IV, item 4.2 (functional impact of dyskinesias)
     UDysRS Total Objective Score (Parts III and IV)
     Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), individual and combined scores (Parts I, II, III)
     Clinician’s Global Impression of Change in overall PD symptoms, determined by a question completed by the investigator
    Change from baseline to Week 8 in the following:
     UDysRS total score
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary outcome measures are changes from baseline to 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 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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
    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 months3
    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 months3
    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 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 72
    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)
    If patients complete the trial, they will be offered to participate in an open label safety study (Protocol Number ADS-AMT-PD302; EudraCT Number 2014-003739-20)
    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 Decision2015-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-10
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