Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
EASE LID 3
ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)
1 other identifier
interventional
77
5 countries
51
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2016
CompletedResults Posted
Study results publicly available
January 10, 2018
CompletedJanuary 10, 2018
January 1, 2018
1.4 years
October 22, 2014
September 21, 2017
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Baseline to Week 12
Secondary Outcomes (1)
Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Baseline to Week 12
Study Arms (2)
ADS-5102 (amantadine HCl extended release)
EXPERIMENTALADS-5102 (amantadine HCl extended release)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Signed a current IRB/REB/IEC-approved informed consent form;
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria;
- 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;
- 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);
- 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);
You may not qualify if:
- History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation);
- History of seizures within 2 years prior to screening;
- History of stroke or TIA within 2 years prior to screening;
- 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;
- Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening;
- If female, is pregnant or lactating;
- If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;
- Treatment with an investigational drug or device within 30 days prior to screening;
- Treatment with an investigational biologic within 6 months prior to screening;
- Current participation in another clinical trial;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Sunnyvale, California, 94085, United States
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Port Charlotte, Florida, 33980, United States
Unknown Facility
Sunrise, Florida, 33351, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Atlanta, Georgia, 30329, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Elkridge, Maryland, 21075, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
West Bloomfield, Michigan, 48322, United States
Unknown Facility
Greensboro, North Carolina, 27405, United States
Unknown Facility
Raleigh, North Carolina, 27607, United States
Unknown Facility
Tulsa, Oklahoma, 74136, United States
Unknown Facility
Roanoke, Virginia, 24018, United States
Unknown Facility
Kirkland, Washington, 98034, United States
Unknown Facility
Morgantown, West Virginia, 26506, United States
Unknown Facility
Milwaukee, Wisconsin, 53233, United States
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Vienna, 1080, Austria
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Vienna, 1220, Austria
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Bordeaux, 33076, France
Unknown Facility
Bron, 69677, France
Unknown Facility
Clermont-Ferrand, 63003, France
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Lille, 59037, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Poitier, 86021, France
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Rennes, 35033, France
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Rouen, 76031, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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München, Bavaria, 80804, Germany
Unknown Facility
München, Bavaria, 81675, Germany
Unknown Facility
Beelitz-Heilstätten, Brandenburg, 14547, Germany
Unknown Facility
Göttingen, Lower Saxony, 37075, Germany
Unknown Facility
Leipzig, Saxony, 04103, Germany
Unknown Facility
Gera, Thuringia, 07751, Germany
Unknown Facility
Stadtroda, Thuringia, 07646, Germany
Unknown Facility
Berlin, 12163, Germany
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Berlin, 13353, Germany
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Hamburg, 22291, Germany
Unknown Facility
Kassel, 34128, Germany
Unknown Facility
Marburg, 35043, Germany
Unknown Facility
Barcelona, 08028, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Barcelona, 08041, Spain
Related Publications (3)
Hauser RA, Mehta SH, Kremens D, Chernick D, Formella AE. Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Dec;10(2):739-751. doi: 10.1007/s40120-021-00256-1. Epub 2021 May 22.
PMID: 34024025DERIVEDMehta SH, Pahwa R, Tanner CM, Hauser RA, Johnson R. Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Jun;10(1):307-320. doi: 10.1007/s40120-021-00246-3. Epub 2021 Apr 17.
PMID: 33864229DERIVEDElmer LW, Juncos JL, Singer C, Truong DD, Criswell SR, Parashos S, Felt L, Johnson R, Patni R. Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease. CNS Drugs. 2018 Apr;32(4):387-398. doi: 10.1007/s40263-018-0498-4.
PMID: 29532440DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head, Regulatory Affairs
- Organization
- Adamas Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trials Director
Adamas Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 24, 2014
Study Start
October 1, 2014
Primary Completion
March 10, 2016
Study Completion
March 10, 2016
Last Updated
January 10, 2018
Results First Posted
January 10, 2018
Record last verified: 2018-01