Medicaments for slowing parkinson's disease
a parkinson's disease and medication technology, applied in the field of medication to slow the progression of parkinson's disease, can solve the problems of no conventional treatment considered to slow the progression of pd, patients may suffer from severe and highly unpredictable and rapid motor fluctuations,
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example 1b
[0074]After completion of the placebo-controlled double-blind (DB) trial—see FIG. 3, 495 (92%) patients continued to a 1-year open label (OL)-part, in which all subjects were treated with OPC (5, 25 or 50-mg OPC). All subjects began with 25-mg OPC QD for 1-week. Then, the investigator freely adjusted the levodopa therapy and / or OPC based on the dopaminergic response and / or associated adverse events. Efficacy variables included the change from baseline in OFF / ON-time, based on patient diaries. Other endpoints include proportion of responders. UPDRS, PDQ-39, NMSS, PDSS and safety assessments (including C—SSRS and mMIDI).
[0075]The data from the trials is shown in FIGS. 1 and 2.
[0076]The demographic details of the patients at baseline of the double blind portion of the study in Example 1A is presented in Table 3 below. The demographic details of the patients at baseline of the open label extension period of the study in Example 1A is presented in Table 4.
TABLE 3Demographic details of PD...
example 2
Introduction:
[0078]Opicapone (OPC) was developed to fulfil the need for more potent, safer and longer acting COMT inhibitors.
Objectives:
[0079]To investigate the effect of a once-daily (QD) OPC (25, 50 and 75 mg) on levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT).
Methods:
[0080]This was a single-centre, double-blind, randomized and placebo-controlled study in 4-groups of 20 (10 male and 10 female) subjects each. The study consisted of QD administration of OPC or placebo for 11 days followed by thrice-daily (every 5 h) 100 / 25 mg levodopa / carbidopa (LC), 200 mg ENT or placebo on Day 12.
Results:
[0081]Levodopa extent of exposure (AUC) was significantly increased up to 78.9% and 73.7% with 75 mg-OPC in comparison to placebo and ENT, respectively. Levodopa-AUCO-24 was higher when LC was administered with any OPC dose than when administered concomitantly with ENT. Peak exposure (Cmax) to levodopa increased (>30%) with 75 mg-OPC following LC administration...
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