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NCT Number: NCT01397422

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.

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Key information

Conditions

Dyskinesia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Levodopa Induced Dyskinesia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADS-5102 (extended release amantadine HCl)

Drug

Oral capsules to be administered once daily at bedtime, for 8 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Adamas Pharmaceuticals, Inc.

Industry

Registry information

Acronym: EASED

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 19, 2011
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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