PMID- 28777755
OWN - NLM
STAT- MEDLINE
DCOM- 20180430
LR  - 20220317
IS  - 1877-718X (Electronic)
IS  - 1877-7171 (Print)
IS  - 1877-7171 (Linking)
VI  - 7
IP  - 3
DP  - 2017
TI  - ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia 
      in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label 
      Safety Study.
PG  - 511-522
LID - 10.3233/JPD-171134 [doi]
AB  - BACKGROUND: Medical treatment of levodopa-induced dyskinesia (LID) in Parkinson's 
      disease (PD) is an unmet need. ADS-5102 (amantadine) extended-release capsules is 
      being developed for the treatment of LID in patients with PD. OBJECTIVE: Evaluate 
      the long-term safety and tolerability of 274 mg ADS-5102 for LID in PD. METHODS: 
      In an ongoing, open-label safety study (NCT02202551), PD patients with LID 
      received 274 mg of ADS-5102 once daily at bedtime. Patients were recruited from 
      previous ADS-5102 trials. In addition, patients were enrolled who were ineligible 
      for previous ADS-5102 trials due to previous implantation of deep-brain 
      stimulation (DBS) devices. The primary outcome measure was safety assessed 
      through adverse events (AEs). Efficacy was assessed using the Movement Disorder 
      Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part IV and its 
      subparts. RESULTS: For this interim analysis, 223 patients received ADS-5102 for 
      a mean duration of 348 (SD 182) days. The most common AEs included falls (25.1%), 
      visual hallucinations (19.3%), peripheral edema (13.0%), and constipation 
      (12.6%). Overall, 32 patients (14.3%) discontinued due to an AE. In patients 
      receiving placebo in previous studies, the mean MDS-UPDRS, Part IV scores 
      decreased by 3.4 points from baseline (n = 78) to week 8 and remained stable 
      through week 64 (n = 21). In patients receiving ADS-5102 in previous studies, the 
      mean baseline (n = 61) MDS-UPDRS, Part IV score was low due to the response to 
      ADS-5102 in previous studies and remained stable through week 64 (total of 88 
      weeks; n = 21). The effect was primarily due to reduction in item 4.2 (functional 
      impact of dyskinesia) and item 4.4 (functional impact of motor fluctuations). 
      CONCLUSIONS: ADS-5102 was generally well tolerated in all groups, including DBS 
      patients, and the safety profile was consistent with previous controlled studies. 
      Long-term durability and tolerability were shown from the double-blind studies 
      through participation in the open-label study up to 88 weeks.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - University of South Florida, Tampa, FL, USA.
FAU - Pahwa, Rajesh
AU  - Pahwa R
AD  - University of Kansas Medical Center, Kansas City, KS, USA.
FAU - Tanner, Caroline M
AU  - Tanner CM
AD  - University of California San Francisco and San Francisco Veterans Affairs Medical 
      Center, San Francisco, CA, USA.
FAU - Oertel, Wolfgang
AU  - Oertel W
AD  - Philipps University, Marburg, Germany.
FAU - Isaacson, Stuart H
AU  - Isaacson SH
AD  - Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, 
      USA.
FAU - Johnson, Reed
AU  - Johnson R
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Felt, Larissa
AU  - Felt L
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Stempien, Mary Jean
AU  - Stempien MJ
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02202551
SI  - ClinicalTrials.gov/NCT02202551
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Parkinsons Dis
JT  - Journal of Parkinson's disease
JID - 101567362
RN  - 46627O600J (Levodopa)
RN  - BF4C9Z1J53 (Amantadine)
SB  - IM
MH  - Aged
MH  - Amantadine/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Delivery Systems
MH  - Dyskinesia, Drug-Induced/*drug therapy
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Levodopa/*adverse effects
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC5611804
OTO - NOTNLM
OT  - Parkinson's disease
OT  - amantadine
OT  - dyskinesia
OT  - levodopa-induced dyskinesia
EDAT- 2017/08/05 06:00
MHDA- 2018/05/01 06:00
PMCR- 2017/09/25
CRDT- 2017/08/05 06:00
PHST- 2017/08/05 06:00 [pubmed]
PHST- 2018/05/01 06:00 [medline]
PHST- 2017/08/05 06:00 [entrez]
PHST- 2017/09/25 00:00 [pmc-release]
AID - JPD171134 [pii]
AID - 10.3233/JPD-171134 [doi]
PST - ppublish
SO  - J Parkinsons Dis. 2017;7(3):511-522. doi: 10.3233/JPD-171134.