Clinical trial NCT01397422: Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Official title: Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dyskinesia
Levodopa Induced Dyskinesia
Parkinson's Disease
Keywords: Levodopa-induced dyskinesia
Parkinsonism
Lead sponsor: Adamas Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
timeFrame: Baseline (Day 1) and Week 8
Secondary outcomes:
measure: Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
timeFrame: Baseline (Day 1) and Week 8
measure: Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
timeFrame: Baseline (Day 1) and Week 8
measure: Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
timeFrame: Baseline (Day 1) and Week 8
measure: Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
timeFrame: Baseline (Day 1) and Week 8
measure: Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
timeFrame: Baseline (Day 1) and Week 8
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oxnard
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Reseda
country: United States
state: California
city: Sunnyvale
country: United States
state: California
city: Ventura
country: United States
state: California
city: Fairfield
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Winfield
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: West Bloomfield
country: United States
state: Michigan
city: Toms River
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Adamas Pharmaceuticals, Inc.
name: Clinical Trials Director
role: STUDY_DIRECTOR
References: