A randomized, double-blind, controlled trial of add-on therapy in moderate-to-severe Parkinson's disease.
OBJECTIVE
The primary objective was to evaluate the efficacy and safety of droxidopa as add-on therapy in improving stiffness, tremors and other motor functions and activities of daily living for moderate-to-severe Parkinson's disease (PD).


METHODS
PD patients, above Hoehn-Yahr III (including Hoehn-Yahr III), were randomly assigned to drug therapy (droxidopa 600 mg/day for 8 weeks) or placebo. Efficacy indicators were the Unified Parkinson's Disease Rating Scale (UPDRS) part I, II, III subscale, Clinical Global Impression (CGI) rating score, and individual symptom scores (e.g. stiffness, tremors), to evaluate motor function and activities of daily life.


RESULTS
There are 109 patients in the droxidopa group, and 110 in the placebo group, at baseline, there were no differences between the two groups for age, body weight, disease severity and previous drugs therapy. At days 14 and 57 of droxidopa add on treatment, UPDRS-II scores reflecting activities of daily life and UPDRS-III scores reflecting motor functions were significantly different compared to the pre-treatment baseline scores (P < 0.01), UPDRS- II and UPDRS-III scores at day 14 and day 57 were also significantly different (P < 0.01) between the two groups. Individual motor symptoms such as stiffness, resting tremor, and alternate hand motion were also significantly improved with droxidopa on days 14 and 57 of treatment (P < 0.01 vs placebo), showing that droxidopa is effective in improving rigidity, tremor and alternate motion of hand.


CONCLUSIONS
Droxidopa was effective as symptomatic adjunct therapy, improved significantly motor function and activities of daily living, benefited patients with signs of tremor and Stiffness.
Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China. Electronic address: shifuzhao@163.com.
Shifu
S
Zhao
Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China.
Rongchuan
R
Cheng
Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China. Electronic address: Jzheng59@hotmail.com.
Jian
J
Zheng
Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing 400037, China.
Qianning
Q
Li
Department of Neurology, Daping Hospital, Third Military Medical University, Chongqing 400000, China.
Jingzhou
J
Wang
Department of Neurology, Xinan Hospital, Third Military Medical University, Chongqing 400038, China.
Wenhui
W
Fan
Department of Neurology, Daping Hospital, Third Military Medical University, Chongqing 400000, China.
Lili
L
Zhang
Department of Neurology, Xinan Hospital, Third Military Medical University, Chongqing 400038, China.
Yanling
Y
Zhang
Department of Neurology, TangDu Hospital, Fouth Military Medical University, Xi'an 710038, China.
Hongzeng
H
Li
Department of Neurology, Kunming General Hospital of Chengdu Military Region, Kunming 650032, China.
Shuxiao
S
Liu
D000203:Activities of Daily Living; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D015103:Droxidopa / Q000008:administration & dosage*; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D015103:Droxidopa
Add-on; Droxidopa; Motor fuction; Norepinnehrine; Parkinson’s disease