Parkinson’s Disease

Research Article

Efficacy and Safety of Pramipexole Sustained Release versus Immediate Release Formulation for Nocturnal Symptoms in Chinese Patients with Advanced Parkinson’s Disease: A Pilot Study

Table 2

Demographics and baseline characteristics (TS).


	Pramipexole SR (N = 49)	Pramipexole IR (N = 49)

Male, n (%)	28 (57.1)	31 (63.3)
Age (years), mean (SD)	61.1 (10.8)	60.9 (8.8)
Age (years), min-max	31–79	42–79
BMI (kg/m²), mean (SD)	22.8 (3.4)	23.9 (3.0)
Disease duration (years), mean (SD)	4.9 (3.7)	5.1 (3.0)
Hoehn & Yahr stage II-III on time, n (%)	49 (100.0)	49 (100.0)
PDSS-2 total score, mean (SD)	27.8 (6.5)	29.2 (8.5)
MMSE score, mean (SD)	28.5 (1.6)	27.9 (1.8)
UPDRS part II total score, mean (SD)	16.6 (5.75)	17.2 (5.65)
UPDRS part IV total score, mean (SD)	7.5 (2.86)	6.6 (2.61)
Levodopa daily dosage, mg, mean (SD)	383.2 (158.1)	444.4 (169.3)
Levodopa equivalent dose, mg, mean (SD)	555.0 (264.1)	594.9 (263.4)
Concomitant PD therapies, n (%)	49 (100.0)	49 (100.0)
Dopa and dopa derivatives	49 (100.0)	49 (100.0)
Adamantane derivatives	12 (24.5)	15 (30.6)
MAO-B inhibitors	16 (32.7)	11 (22.4)
Tertiary amines⁺	3 (6.1)	5 (10.2)
Dopamine agonist	0 (0.0)	1 (2.0)^§
Other dopaminergic agents^‡	5 (10.2)	2 (4.1)

Patients must not have been treated with dopamine agonists within 4 weeks prior to randomisation visit. A concomitant treatment with one or more of the following drugs will be allowed (at a stable dose for at least 4 weeks prior to randomisation visit and the investigator does not intend to change this treatment during the treatment phase): anti-Parkinsonian anticholinergics, selegiline, rasagiline, or other MAO-B-Inhibitor, amantadine, or entacapone (or other COMT-inhibitor). ⁺Tertiary amines included the preferred name “trihexyphenidyl hydrochloride” and “trihexyphenidyl.” ^‡Other dopaminergic agents included the preferred name “entacapone.” ^§One patient in the pramipexole IR group was treated with dopamine agonist (piribedil) which was prohibited according to the exclusion criteria. The patient was documented as an important protocol deviation and excluded from the sensitivity analysis. BMI, body mass index; IR, immediate release; MAO-B, monoamine oxidase type B; MMSE, Mini-Mental State Examination; PD, Parkinson’s disease; PDSS-2, Parkinson’s Disease Sleep Scale 2^nd version; SD, standard deviation; SR, sustained release; TS, treated set.