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DyskinesiaPhase 3EASE LID 3NCT02274766

Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia

A Phase 3 study testing ADS-5102 in people with Dyskinesia and Levodopa-Induced Dyskinesia (LID), run by Adamas Pharmaceuticals, Inc. at 51 sites in 5 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
77 participants
Where
51 sitesin 5 countries
Study dates
Oct 2014to 10 Mar 2016
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 (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);

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 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;
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, 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;

Trial locations and contacts

51 sites in 5 countries.

51 sites in 5 countries

United States21 sites

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Greensboro, North Carolina, 27405

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Milwaukee, Wisconsin, 53233

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Port Charlotte, Florida, 33980

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Roanoke, Virginia, 24018

  • Study site

    Sunnyvale, California, 94085

  • Study site

    Sunrise, Florida, 33351

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    West Bloomfield, Michigan, 48322

Other trials in United States

Germany12 sites

  • Study site

    Beelitz-Heilstätten, Brandenburg, 14547

  • Study site

    Berlin, 12163

  • Study site

    Berlin, 13353

  • Study site

    Gera, Thuringia, 07751

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Hamburg, 22291

  • Study site

    Kassel, 34128

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Marburg, 35043

  • Study site

    München, Bavaria, 80804

  • Study site

    München, Bavaria, 81675

  • Study site

    Stadtroda, Thuringia, 07646

Other trials in Germany

France11 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Bron, 69677

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13385

  • Study site

    Montpellier, 34295

  • Study site

    Poitier, 86021

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76031

  • Study site

    Strasbourg, 67098

  • Study site

    Toulouse, 31059

Other trials in France

Spain4 sites

  • Study site

    Barcelona, 08028

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Barcelona, 08041

Other trials in Spain

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Vienna, 1080

  • Study site

    Vienna, 1220

Other trials in Austria

About this study

Official title: ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 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, Parkinson's Disease
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 13 weeks.

  • PlaceboOther

    Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Study groups in NCT02274766
Study groupRoleWhat they receive
ADS-5102 (amantadine HCl extended release)ExperimentalADS-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 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.

    Measured: Baseline to Week 12

Secondary outcomes (1)

  1. Change in the Standardized PD Home Diary (ON Time Without 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, 4, 8, and 12 visits.

    Measured: Baseline to Week 12

Timeline

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

  1. First posted24 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion10 Mar 2016
  4. Study completion10 Mar 2016

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
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02274766
Sponsor's protocol ID
ADS-AMT-PD304
Acronym
EASE LID 3
Status last verified
Jan 2018
First submitted
22 Oct 2014
Last updated
10 Jan 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

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 51 sites in 5 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Germany, France, Spain, Austria. 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 10 Jan 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 in the Unified Dyskinesia Rating Scale (UDysRS) Total Score (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 NCT02274766, which also lists 3 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 10 Jan 2018.

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