Back to resultsADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study) (EASE LID)
Primary Purpose
Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ADS-5102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyskinesia focused on measuring Levodopa Induced Dyskinesia, LID, Parkinsonism
Eligibility Criteria
Inclusion Criteria:
- 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 (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)
Exclusion Criteria:
- 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 transient ischemic attack (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 or in situ cervical cancer
- 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.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADS-5102
Placebo
Arm Description
ADS-5102 (amantadine HCl extended release)
Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
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, 8, 12, 18, and 24.
Secondary Outcome Measures
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
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, 8, 12, 18, and 24.
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.
Full Information
NCT ID
NCT02136914
First Posted
May 9, 2014
Last Updated
January 9, 2018
Sponsor
Adamas Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02136914
Brief Title
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
Acronym
EASE LID
Official Title
Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adamas Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyskinesia, Levodopa Induced Dyskinesia (LID), Parkinson's Disease
Keywords
Levodopa Induced Dyskinesia, LID, Parkinsonism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADS-5102
Arm Type
Experimental
Arm Description
ADS-5102 (amantadine HCl extended release)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ADS-5102
Other Intervention Name(s)
amantadine HCl extended release
Intervention Description
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
Description
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, 8, 12, 18, and 24.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
Description
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, 8, 12, 18, and 24.
Time Frame
Baseline to Week 24
Title
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Description
A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.
Time Frame
Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Title
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
Description
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.
Time Frame
Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Title
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Description
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.
Time Frame
Baseline to Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 (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)
Exclusion Criteria:
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 transient ischemic attack (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 or in situ cervical cancer
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Director
Organizational Affiliation
Adamas Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
34024025
Citation
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.
Results Reference
derived
PubMed Identifier
33864229
Citation
Mehta 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.
Results Reference
derived
PubMed Identifier
29532440
Citation
Elmer 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. Erratum In: CNS Drugs. 2018 Apr 10;:
Results Reference
derived
PubMed Identifier
28604926
Citation
Pahwa R, Tanner CM, Hauser RA, Isaacson SH, Nausieda PA, Truong DD, Agarwal P, Hull KL, Lyons KE, Johnson R, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson Disease (EASE LID Study): A Randomized Clinical Trial. JAMA Neurol. 2017 Aug 1;74(8):941-949. doi: 10.1001/jamaneurol.2017.0943.
Results Reference
derived
Learn more about this trial
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
We'll reach out to this number within 24 hrs