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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01397422
First received: July 18, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Objective Score (III, IV) of the UDysRS [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS), individual and combined scores (Parts I, II, III) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • Clinician's Global Impression of Change in overall PD symptoms [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • Fatigue Severity Score (FSS) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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

No publications provided

Responsible Party: Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01397422     History of Changes
Other Study ID Numbers: ADS-PAR-AM201
Study First Received: July 18, 2011
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 16, 2014