We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
July 18, 2011
July 19, 2011
October 7, 2017
November 6, 2017
November 6, 2017
July 2011
May 2013   (Final data collection date for primary outcome measure)
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.
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score [ Time Frame: Baseline (Day 1) to Week 8 ]
Complete list of historical versions of study NCT01397422 on ClinicalTrials.gov Archive Site
  • 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.
  • Total Objective Score (III, IV) of the UDysRS [ Time Frame: Baseline (Day 1) to Week 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 ]
  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Individual and Combined Scores (Parts I, II, III) [ Time Frame: Baseline (Day 1) to Week 8 ]
  • Clinician's Global Impression of Change in overall PD symptoms [ Time Frame: Baseline (Day 1) to Week 8 ]
  • Fatigue Severity Score (FSS) [ Time Frame: Baseline (Day 1) to Week 8 ]
Not Provided
Not Provided
 
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dyskinesia
  • Levodopa Induced Dyskinesia
  • Parkinson's Disease
Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
  • Placebo Comparator: Treatment A
    Intervention: Drug: ADS-5102 (extended release amantadine HCl)
  • Active Comparator: Treatment B
    Low dose ADS-5102 (amantadine extended release)
    Intervention: Drug: ADS-5102 (extended release amantadine HCl)
  • Active Comparator: Treatment C
    A mid-dose ADS-5102 (amantadine extended release)
    Intervention: Drug: ADS-5102 (extended release amantadine HCl)
  • Active Comparator: Treatment D
    High dose ADS-5102 (amantadine extended release)
    Intervention: Drug: ADS-5102 (extended release amantadine HCl)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01397422
ADS-PAR-AM201
Yes
Not Provided
Not Provided
Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
Not Provided
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP