Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01397422
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : November 6, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE July 18, 2011
First Posted Date  ICMJE July 19, 2011
Results First Submitted Date  ICMJE October 7, 2017
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date December 13, 2017
Study Start Date  ICMJE July 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 [ Time Frame: Baseline (Day 1) and 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 last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score [ Time Frame: Baseline (Day 1) to Week 8 ]
Change History Complete list of historical versions of study NCT01397422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 [ Time Frame: Baseline (Day 1) and 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.
  • Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 [ Time Frame: Baseline (Day 1) and 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.
  • 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 [ Time Frame: Baseline (Day 1) and 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 8 visit.
  • Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 [ Time Frame: Baseline (Day 1) and 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.
  • Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 [ Time Frame: Baseline (Day 1) and 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Official Title  ICMJE Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dyskinesia
  • Levodopa Induced Dyskinesia
  • Parkinson's Disease
Intervention  ICMJE Drug: ADS-5102 (extended release amantadine HCl)
Oral capsules to be administered once daily at bedtime, for 8 weeks
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2011)
80
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01397422
Other Study ID Numbers  ICMJE ADS-PAR-AM201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adamas Pharmaceuticals, Inc.
Study Sponsor  ICMJE Adamas Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
PRS Account Adamas Pharmaceuticals, Inc.
Verification Date November 2017

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