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Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients.

Abstract：

BACKGROUND:IPX066, an investigational extended-release carbidopa-levodopa (CD-LD) preparation, has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson's disease (PD). This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone (CL + E). METHODS:At baseline, all patients had motor fluctuations despite a stable regimen of CL + E or CD-LD-entacapone combination tablets (CLE). The study included a 6-week conversion from CL + E or CLE to IPX066, followed by two 2-week, double-blind crossover treatment periods in randomized order, one on IPX066 (and placebo CL + E), the other on CL + E (and placebo IPX066), separated by 1-week open-label IPX066 treatment. The primary efficacy measure was mean percent daily "off" time during waking hours (from patient diaries). RESULTS:Of 91 randomized patients, 84 completed the study. Their median daily LD dosage was 1495 mg from IPX066 and 600 mg from CL + E, corresponding, after correction for bioavailability, to an approximately 22% higher LD exposure on IPX066. Compared with CL + E, IPX066 demonstrated a lower percent "off" time (24.0% vs. 32.5%; p < 0.0001), lower "off" time (3.8 vs. 5.2 h/day; p < 0.0001), and higher "on" time without troublesome dyskinesia (11.4 vs. 10.0 h/day; p < 0.0001). Other endpoints, including patient-reported treatment preference, also favored IPX066 (p < 0.05). During double-blind treatment, 20.2% and 13.6% of patients reported adverse events on IPX066 and CL + E, respectively. The most common were dyskinesia (4 patients), insomnia (3), and confusional state (3) for IPX066, and fall (2) for CL + E. CONCLUSIONS:In advanced PD, IPX066 showed improved efficacy, compared with CL + E, and appeared to be well tolerated.

journal_name

Parkinsonism Relat Disord

journal_title

Parkinsonism & related disorders

authors

Stocchi F,Hsu A,Khanna S,Ellenbogen A,Mahler A,Liang G,Dillmann U,Rubens R,Kell S,Gupta S

doi

10.1016/j.parkreldis.2014.08.004

subject

Has Abstract

pub_date

2014-12-01 00:00:00

pages

1335-40

issue

eissn

1353-8020

issn

1873-5126

pii

S1353-8020(14)00302-2

journal_volume

pub_type

杂志文章,随机对照试验

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Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients.