Clinical trial of Madopar HBS in parkinsonian patients with fluctuating drug response after long-term levodopa therapy.
23 parkinsonian patients, 11 men and 12 women with an average age of 62 +/- 10 years, were recruited for an open substitution study of standard Madopar by Madopar HBS (hydrodynamically balanced system). All patients were presenting fluctuations in efficacy associated or not with abnormal involuntary movements. The patients in this study had been suffering from Parkinson's disease for 16 +/- 6 years and were severely disabled (Hoehn and Yahr grade III-V). The substitution was carried out dose for dose from one day to another. During the first month the dosage titration was aimed at finding the optimal therapeutic effect. After 120 days 13 patients were continuing the treatment while 10 had stopped it because of lack of therapeutic advantage. After 120 days, as compared to the initial state, end-of-dose fluctuations improved by 47%, the parkinsonian symptomatology by 54% and the abnormal involuntary movements improved by 33%. The daily dose of Levodopa had to be increased from 580 +/- 230 to 710 +/- 240 mg. The results obtained were excellent in 5 cases, good in 6 and moderate in 2 cases.
Rondot
P
P
Service de Neurologie, Hôpital Sainte-Anne, Paris, France.
Ziegler
M
M
Aymard
N
N
Holzer
J
J
D000368:Aged; D001545:Benserazide / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004338:Drug Combinations / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006834:Hydrazines / Q000627:therapeutic use*; D007980:Levodopa / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009069:Movement Disorders / Q000188:drug therapy* / Q000209:etiology; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
D003692:Delayed-Action Preparations; D004338:Drug Combinations; D006834:Hydrazines; C005177:benserazide, levodopa drug combination; D007980:Levodopa; D001545:Benserazide