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DyskinesiaPhase 3EASE LIDNCT02136914

ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)

A Phase 3 study testing ADS-5102 in people with Dyskinesia and Levodopa Induced Dyskinesia (LID), run by Adamas Pharmaceuticals, Inc. at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
ADS-5102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
46 sitesin 2 countries
Study dates
May 2014to Dec 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States43 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Bingham Farms, Michigan, 48025

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Commack, New York, 11725

  • Study site

    Dallas, Texas, 75390

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Golden Valley, Minnesota, 55427

  • Study site

    Houston, Texas, 77030-1

  • Study site

    Houston, Texas, 77030-2

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Manchester, Connecticut, 06040

  • Study site

    Milwaukee, Wisconsin, 53233

  • Study site

    Naples, Florida, 34102

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10029

  • Study site

    Pasadena, California, 91105

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Reseda, California, 91335

  • Study site

    Sacramento, California, 95817

  • Study site

    Scottsdale, Arizona, 85259

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Sun City, Arizona, 85351

  • Study site

    Sunrise, Florida, 33351

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Torrance, California, 90505

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Ventura, California, 93003

  • Study site

    West Bloomfield, Michigan, 48322

  • Study site

    Weston, Florida, 33331

Other trials in United States

Canada3 sites

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Regina, Saskatchewan, S4T 1A5

  • Study site

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

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)

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.

Being tested
ADS-5102, Placebo
Keywords
Levodopa Induced Dyskinesia, LID, Parkinsonism
Medical subject headings
Dyskinesias, Parkinson Disease, Parkinsonian Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ADS-5102Drug

    Also called amantadine HCl extended release

    Oral capsules to be administered once nightly at bedtime, for 25 weeks

  • PlaceboOther

    Oral capsules to be administered once nightly at bedtime, for 25 weeks

Study groups in NCT02136914
Study groupRoleWhat they receive
ADS-5102ExperimentalADS-5102 (amantadine HCl extended release)
Receives: Drug: ADS-5102
PlaceboPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 12

Secondary outcomes (4)

  1. 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.

    Measured: Baseline to Week 24

  2. 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.

    Measured: Baseline (BL) to Week 12 (W12) and Week 24 (W24)

  3. 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.

    Measured: Baseline (BL) to Week 12 (W12) and Week 24 (W24)

  4. 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.

    Measured: Baseline to Week 12 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02136914
Sponsor's protocol ID
ADS-AMT-PD301
Acronym
EASE LID
Status last verified
Jan 2018
First submitted
9 May 2014
Last updated
6 Feb 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 34024025

  • 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.

    PubMed 33864229

  • 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.

    PubMed 29532440

  • 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.

    PubMed 28604926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ADS-5102 in people with Dyskinesia and Levodopa Induced Dyskinesia (LID), run by Adamas Pharmaceuticals, Inc. at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12 (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02136914, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.

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