PMID- 29368539
OWN - NLM
STAT- MEDLINE
DCOM- 20200109
LR  - 20200109
IS  - 1477-0970 (Electronic)
IS  - 1352-4585 (Linking)
VI  - 25
IP  - 4
DP  - 2019 Apr
TI  - Safety and efficacy of ADS-5102 (amantadine) extended release capsules to improve 
      walking in multiple sclerosis: A randomized, placebo-controlled, phase 2 trial.
PG  - 601-609
LID - 10.1177/1352458518754716 [doi]
AB  - BACKGROUND: Walking impairment causes disability and reduced quality of life in 
      patients with multiple sclerosis (MS). OBJECTIVE: Characterize the safety and 
      efficacy of ADS-5102 (amantadine) extended release capsules, 274 mg administered 
      once daily at bedtime in patients with MS with walking impairment. METHODS: This 
      randomized, double-blind, placebo-controlled, 4-week study was conducted at 14 
      trial sites in the United States. Study objectives included safety and 
      tolerability of ADS-5102, and efficacy assessments (Timed 25-Foot Walk (T25FW), 
      Timed Up and Go (TUG), 2-Minute Walk Test, and Multiple Sclerosis Walking 
      Scale-12). Fatigue, depression, and cognition also were assessed. RESULTS: A 
      total of 60 patients were randomized (30 to ADS-5102 and 30 to placebo); 59 of 
      whom were treated. The most frequent adverse events (AEs) were dry mouth, 
      constipation, and insomnia. Five ADS-5102 patients and no placebo patients 
      discontinued treatment due to AEs. One patient in the ADS-5102 group experienced 
      a serious AE-suspected serotonin syndrome. A 16.6% placebo-adjusted improvement 
      was seen in the T25FW test ( p < 0.05). A 10% placebo-adjusted improvement in TUG 
      was also observed. No changes in fatigue, depression, or cognition were observed. 
      CONCLUSION: ADS-5102 was generally well tolerated. These data demonstrate an 
      effect of ADS-5102 on walking speed. Further studies are warranted to confirm 
      these observations.
FAU - Cohen, Jeffrey A
AU  - Cohen JA
AD  - Mellen Center for Multiple Sclerosis Treatment and Research, Neurological 
      Institute, Cleveland Clinic, Cleveland, OH, USA.
FAU - Hunter, Samuel F
AU  - Hunter SF
AD  - Advanced Neuroscience Institute, Franklin, TN, USA.
FAU - Brown, Theodore R
AU  - Brown TR
AD  - Multiple Sclerosis Center, Evergreen Health, Kirkland, WA, USA.
FAU - Gudesblatt, Mark
AU  - Gudesblatt M
AD  - Comprehensive Multiple Sclerosis Care Center, South Shore Neurologic Associates, 
      P.C., Patchogue, NY, USA.
FAU - Thrower, Ben W
AU  - Thrower BW
AD  - Crawford Research Institute, Shepherd Center, Atlanta, GA, USA.
FAU - Llorens, Lily
AU  - Llorens L
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Souza-Prien, Cindy J
AU  - Souza-Prien CJ
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Ruby, April E
AU  - Ruby AE
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Chernoff, David N
AU  - Chernoff DN
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
FAU - Patni, Rajiv
AU  - Patni R
AD  - Adamas Pharmaceuticals, Inc., Emeryville, CA, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180125
PL  - England
TA  - Mult Scler
JT  - Multiple sclerosis (Houndmills, Basingstoke, England)
JID - 9509185
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dopamine Agents)
RN  - BF4C9Z1J53 (Amantadine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amantadine/administration & dosage/adverse effects/*pharmacology
MH  - Delayed-Action Preparations
MH  - Dopamine Agents/administration & dosage/adverse effects/*pharmacology
MH  - Double-Blind Method
MH  - Dyskinesias/*drug therapy/etiology/physiopathology
MH  - Exercise Test
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Sclerosis/complications/*drug therapy/physiopathology
MH  - *Outcome Assessment, Health Care
MH  - Proof of Concept Study
MH  - *Walking
OTO - NOTNLM
OT  - ADS-5102
OT  - MS
OT  - Multiple sclerosis
OT  - amantadine
OT  - walking
OT  - walking impairment
OT  - walking speed
EDAT- 2018/01/26 06:00
MHDA- 2020/01/10 06:00
CRDT- 2018/01/26 06:00
PHST- 2018/01/26 06:00 [pubmed]
PHST- 2020/01/10 06:00 [medline]
PHST- 2018/01/26 06:00 [entrez]
AID - 10.1177/1352458518754716 [doi]
PST - ppublish
SO  - Mult Scler. 2019 Apr;25(4):601-609. doi: 10.1177/1352458518754716. Epub 2018 Jan 
      25.