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Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study) (EASED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397422
First Posted: July 19, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
  Purpose
This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily 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) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.

Condition Intervention Phase
Dyskinesia Levodopa Induced Dyskinesia Parkinson's Disease Drug: ADS-5102 (extended release amantadine HCl) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

Resource links provided by NLM:


Further study details as provided by Adamas Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score [ Time Frame: Baseline (Day 1) to Week 8 ]
    The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 6, and 8. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.


Secondary Outcome Measures:
  • Fatigue Severity Score (FSS) [ Time Frame: Baseline (Day 1) to Week 8 ]
    The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.

  • Total Objective Score (III, IV) of the UDysRS [ Time Frame: Baseline (Day 1) to Week 8 ]
    UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia. The UDysRS was measured at Baseline and Weeks 2, 4, 6, and 8.

  • ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia), Based on a Standardized PD Home Diary [ Time Frame: Baseline (Day 1) to Week 8 ]
    A PD home diary was used to score 5 different conditions in 30-minute time 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, 6, and 8 visits.

  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Individual and Combined Scores (Parts I, II, III) [ Time Frame: Baseline (Day 1) to Week 8 ]
    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 had sub scales ranging from normal = 0 to severe = 4. Assessments were performed at Baseline and Weeks 2, 4, and 8.

  • Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms [ Time Frame: Baseline (Day 1) to Week 8 ]
    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, 4, 6, and 8.


Enrollment: 83
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Active Comparator: Treatment B
Low dose ADS-5102 (amantadine extended release)
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Active Comparator: Treatment C
A mid-dose ADS-5102 (amantadine extended release)
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Active Comparator: Treatment D
High dose ADS-5102 (amantadine extended release)
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed a current IRB/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 , including any levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation
  • Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)
  • Able to understand and complete a standardized PD home diary, following training

Exclusion Criteria:

  • History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation)
  • History of seizures or stroke/TIA within 2 years of screening
  • History of cancer within 5 years of screening, except adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer or in situ cervical cancer
  • Estimated GFR < 50 mL/min/1.73m2
  • 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, or has a positive pregnancy test result pre-dose
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397422


  Hide Study Locations
Locations
United States, Arizona
Sun City, Arizona, United States
United States, California
Fountain Valley, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Oxnard, California, United States
Pasadena, California, United States
Reseda, California, United States
Sunnyvale, California, United States
Ventura, California, United States
United States, Connecticut
Fairfield, Connecticut, United States
United States, Florida
Boca Raton, Florida, United States
Bradenton, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Winfield, Illinois, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
West Bloomfield Township, Michigan, United States
United States, New Jersey
Toms River, New Jersey, United States
United States, New York
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
United States, Washington
Kirkland, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Adamas Pharmaceuticals, Inc.
Investigators
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
  More Information

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01397422     History of Changes
Other Study ID Numbers: ADS-PAR-AM201
First Submitted: July 18, 2011
First Posted: July 19, 2011
Results First Submitted: October 7, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: February 2017

Keywords provided by Adamas Pharmaceuticals, Inc.:
Levodopa-induced dyskinesia
Parkinsonism

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents