Phase 3
N=83
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Dyskinesia · Levodopa Induced Dyskinesia · Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01397422 ↗Enrolled (actual)
83
Serious AEs
6.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 — -6.7; -12.3; -17.9; -16.7 units on a scale — p=0.0051
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ADS-5102 (extended release amantadine HCl) (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Adamas Pharmaceuticals, Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8 |
-6.7; -12.3; -17.9; -16.7 | 0.0051 sig |
| SECONDARY Change in the Fatigue Severity Score (FSS) From Baseline to Week 8 |
-0.25; -0.06; -0.55; 0.00 | 0.4314 |
| SECONDARY Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8 |
-1.9; -4.4; -7.1; -8.3 | 0.0038 sig |
| SECONDARY 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 |
0.9; 4.1; 3.8; 3.6 | 0.0078 sig |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8 |
-1.2; 0.0; -3.4; 0.5 | 0.6355 |
| SECONDARY Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8 |
1; 2; 7; 4; 6; 8 | 0.0036 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01397422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.