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

January 9, 2018 updated by: Adamas Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Scottsdale, Arizona, United States, 85259
      • Sun City, Arizona, United States, 85351
    • California
      • Fountain Valley, California, United States, 92708
      • Pasadena, California, United States, 91105
      • Reseda, California, United States, 91335
      • Sacramento, California, United States, 95817
      • Torrance, California, United States, 90505
      • Ventura, California, United States, 93003
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • Manchester, Connecticut, United States, 06040
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Gainesville, Florida, United States, 32607
      • Naples, Florida, United States, 34102
      • Port Charlotte, Florida, United States, 33980
      • Sunrise, Florida, United States, 33351
      • Tampa, Florida, United States, 33613
      • Weston, Florida, United States, 33331
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Iowa
      • Des Moines, Iowa, United States, 50309
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
      • West Bloomfield, Michigan, United States, 48322
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • New York
      • Albany, New York, United States, 12208
      • Commack, New York, United States, 11725
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
      • New York, New York, United States, 10003
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Toledo, Ohio, United States, 43614
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030-1
      • Houston, Texas, United States, 77030-2
    • Washington
      • Kirkland, Washington, United States, 98034
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Experimental: ADS-5102
ADS-5102 (amantadine HCl extended release)
Drug: ADS-5102
Oral capsules to be administered once nightly at bedtime, for 25 weeks
Other Names:
  • amantadine HCl extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12
Time Frame: Baseline to 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.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24
Time Frame: Baseline to 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.
Baseline to Week 24
Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)
Time Frame: Baseline (BL) to Week 12 (W12) and Week 24 (W24)
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.
Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)
Time Frame: Baseline (BL) to Week 12 (W12) and Week 24 (W24)
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.
Baseline (BL) to Week 12 (W12) and Week 24 (W24)
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms
Time Frame: Baseline to Week 12 and Week 24
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.
Baseline to Week 12 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adamas Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

January 9, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADS-AMT-PD301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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