Open-Label Safety Study of ADS-5102 in PD Patients With LID

September 15, 2020 updated by: Adamas Pharmaceuticals, Inc.

Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participation in this study was offered to subjects who were described by one of the following 3 groups:

  • Group 1: Subjects who completed an Adamas efficacy study evaluating ADS-5102 in LID and chose to immediately transition into the current study without a time gap; this group was subdivided into Group 1A, consisting of subjects who received ADS-5102 in the previous Adamas efficacy study, and Group 1P, consisting of subjects who received placebo in the previous Adamas efficacy study
  • Group 2: Subjects who completed a previous Adamas efficacy study evaluating ADS-5102 in LID and entered the current study with a time gap
  • Group 3: Subjects who would have been deemed ineligible for participation in a previous Adamas efficacy study due to having undergone DBS

Consented subjects who completed Screening (Visit 1) and met study eligibility criteria were to have a Baseline Visit and receive study drug. During Week 1, subjects took 170 mg of ADS-5102 (1 capsule) daily at bedtime. For Week 2, the dose was increased to 340 mg (2 capsules) daily at bedtime; this dose was to continue through Week 100. During the final week (Week 101) of the study, the ADS-5102 dose was reduced to 170 mg (1 capsule) daily at bedtime. Subjects were enrolled into the study at Visit 2 (Baseline/Week 0) and were to return to the clinic after 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 weeks of study drug dosing. Subjects were to receive a telephone reminder at the end of Week 1 to increase their dose during Week 2. At the Week 100 Visit, subjects were instructed to reduce their dose to 1 capsule daily at bedtime for 1 week. The amount of available, unused drug was assessed during the Week 100 Visit; subjects were given an additional bottle of study drug, if needed, to complete the 1 week of reduced dosing.

Efficacy, as measured with the MDS-UPDRS, was to be evaluated at all study visits, beginning with the Screening Visit, and excluding the Baseline and Week 4 Visits. A Safety Follow-up Visit was to occur approximately 2 weeks following the completion of treatment. AEs were recorded beginning with the first dose of study drug and continued through the Safety Follow-up Visit. Concomitant medications were recorded throughout the study.

Study Type

Interventional

Enrollment (Actual)

223

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

  • Austria
      • Innsbruck, Austria, 6020
      • Vienna, Austria, 1080
      • Vienna, Austria, 1220
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
  • France
      • Bordeaux, France, 33076
      • Bron, France, 69677
      • Clermont Ferrand, France, 63003
      • Lille, France, 59037
      • Marseille, France, 13385
      • Montpellier, France, 34295
      • Poitiers, France, 86021
      • Rennes, France, 35033
      • Rouen, France, 76031
      • Strasbourg, France, 67098
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 12163
      • Hamburg, Germany, 22291
      • Kassel, Germany, 34128
      • Marburg, Germany, 35043
    • Bayern
      • München, Bayern, Germany, 81675
      • München, Bayern, Germany, 80804
    • Brandenburg
      • Beelitz-Heilstätten, Brandenburg, Germany, 14547
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
    • Thüringen
      • Gera, Thüringen, Germany, 07751
      • Stadtroda, Thüringen, Germany, 07646
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08028
  • 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
      • Sunnyvale, California, United States, 94085
      • 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
      • Jacksonville, Florida, United States, 32209
      • Naples, Florida, United States, 34102
      • Port Charlotte, Florida, United States, 33980
      • Sunrise, Florida, United States, 33351
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33612
      • Weston, Florida, United States, 33331
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
    • Iowa
      • Des Moines, Iowa, United States, 45219
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Elkridge, Maryland, United States, 21075
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • 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
      • Greensboro, North Carolina, United States, 27405
      • 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
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19107
    • Texas
      • Dallas, Texas, United States, 75390
      • Houston, Texas, United States, 77030-1
      • Houston, Texas, United States, 77030-2
    • Virginia
      • Roanoke, Virginia, United States, 24018
    • Washington
      • Kirkland, Washington, United States, 98034
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
    • 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
  • Completed all study visits in previous Adamas efficacy study or were ineligible for participation in previous Adamas studies due to having undergone prior deep brain stimulation.
  • Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
  • On a stable regimen of antiparkinson's medications at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily.
  • History of peak dose dyskinesia that might benefit from specific dyskinesia treatment in the judgment of the subject and clinical investigator

Exclusion Criteria:

  • Discontinued ADS-5102 in previous Adamas efficacy study due to intolerable or unacceptable AEs considered to be related to ADS-5102
  • History of neurosurgical intervention related to Parkinson's disease, with the exception of deep brain stimulation
  • History of seizures since completion of participation in previous Adamas studies or within 2 years
  • History of stroke or TIA since completion of participation in previous Adamas studies or within 2 years
  • History of cancer since completion of participation in previous Adamas studies or within 2 years, 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 (other than ADS-5102) or device within 30 days prior to screening
  • Treatment with an investigational biologic within 6 months prior to screening
  • Current or planned participation in another interventional 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADS-5102
amantadine HCl extended release
Drug: ADS-5102
Other Names:
  • amantadine HCl extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Reported AEs and Safety-Related Study Drug Discontinuations
Time Frame: Up to 101 weeks
The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
Up to 101 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (Parts I-III Combined Scores)
Time Frame: Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).

To evaluate clinical progression of PD as assessed by the MDS-UPDRS, combined score, Parts I, II, and III.

Part I - non-motor experiences of daily living; Part II - motor experiences of daily living; Part III - motor examination. Parts I and II each contain 13 questions measured on a 5-point scale (0-4). Part III contains 18 objective rater assessments of the motor signs of PD measured on a 5-point scale (0-4).

Total range for combined score (Part I-III) is = 0-176. Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better.

Parts I, II, and III are summed to make the total score.
Up to 101 weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).
Change From Baseline in Movement Disorder's Society - Unified Parkinson's Disease Rating Scale MDS-UPDRS (Part IV - Motor Complications)
Time Frame: 100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).

This component (Questions 4.1 - 4.6) includes time spent with dyskinesia, functional impact of dyskinesia, time spent in OFF state, functional impact of fluctuations, complexity of motor fluctuations, painful OFF-state dystonia. Questions 4.1-4.6 are summed to make the Part IV score.

Generally for MDS-UPDRS scores and sub-scores, the lower the score, the better. Total range for Part IV is = 0-24
100 Weeks. MDS-UPDRS was performed at the following visits: Screening, Week 8, Week 16, Week 28, Week 40, Week 52, Week 64, Week 76, Week 88, Week 100 (or ET).

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

July 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADS-AMT-PD302

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.

Clinical Trials on Parkinson's Disease (PD)

Clinical Trials on ADS-5102

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe