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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adamas Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01397422
First received: July 18, 2011
Last updated: April 7, 2014
Last verified: April 2014

July 18, 2011
April 7, 2014
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01397422 on ClinicalTrials.gov Archive Site
  • Total Objective Score (III, IV) of the UDysRS [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (MDS-UPDRS), individual and combined scores (Parts I, II, III) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • Clinician's Global Impression of Change in overall PD symptoms [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
  • Fatigue Severity Score (FSS) [ Time Frame: Baseline (Day 1) to week 8 ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01397422
ADS-PAR-AM201
Yes
Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
Not Provided
Study Director: Clinical Trials Director Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals, Inc.
April 2014

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