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Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia (EASE LID 3)

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: NCT02274766
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE October 24, 2014
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE January 10, 2018
Last Update Posted Date January 10, 2018
Study Start Date  ICMJE October 2014
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)		 Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score [ Time Frame: Baseline to Week 12 ]
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)		 Change in the Unified Dyskinesia Rating Scale (UDysRS) total score [ Time Frame: Baseline to Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)		 Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time) [ Time Frame: Baseline to Week 12 ]
A PD home diary was used to score 5 different conditions in 30-minute 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, 8, and 12 visits.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)		 Change in the standardized PD home diary (ON time without dyskinesia, ON time with troublesome dyskinesia, OFF time) [ Time Frame: Baseline to Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Official Title  ICMJE ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)
Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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 (LID)
  • Parkinson's Disease (PD)
Intervention  ICMJE
  • Drug: ADS-5102
    Oral capsules to be administered once nightly at bedtime, for 13 weeks.
    Other Name: amantadine HCl extended release
  • Other: Placebo
    Oral capsules to be administered once nightly at bedtime, for 13 weeks.
Study Arms  ICMJE
  • Experimental: ADS-5102 (amantadine HCl extended release)
    ADS-5102 (amantadine HCl extended release)
    Intervention: Drug: ADS-5102
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications *

*   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: May 16, 2016)		 77
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2014)		 72
Actual Study Completion Date  ICMJE March 10, 2016
Actual Primary Completion Date March 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed a current IRB/REB/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 for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily, and willing to continue the same doses and regimens during study participation;
  • Following diary training, the subject is willing and able to understand and complete the 24-hour PD home diary (trained caregiver/study partner assistance allowed);
  • Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis);

Exclusion Criteria:

  • History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation);
  • History of seizures within 2 years prior to screening;
  • History of stroke or TIA within 2 years prior to screening;
  • History of cancer within 5 years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate cancer, in situ cervical cancer, or other definitively treated cancer that is considered cured;
  • 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;
  • 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, using one of the following: barrier methods (diaphragm or partner using condoms plus use of spermicidal jelly or foam, preferably double-barrier methods); oral or implanted hormonal contraceptive; intrauterine device (IUD); or vasectomized male partner;
  • Treatment with an investigational drug or device within 30 days prior to screening;
  • Treatment with an investigational biologic within 6 months prior to screening;
  • Current participation in another clinical trial;
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 Austria,   France,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02274766
Other Study ID Numbers  ICMJE ADS-AMT-PD304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Adamas Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Adamas Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
PRS Account Adamas Pharmaceuticals, Inc.
Verification Date January 2018

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