Parkinson’s Disease / 2014 / Article / Tab 1

Clinical Study

Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study

Table 1

Results of tests measuring various motor and nonmotor symptoms.

Requip (Visit 2) Ralnea (Visit 4)Significance
Median25th percentile75th percentileMedian25th percentile75th percentile

UPDRS and HYSUPDRS part I2.02.04.03.02.55.0 0.566
UPDRS part II15.012.017.015.09.519.00.928
UPDRS part III27.020.531.028.023.033.50.505
UPDRS part IV8.05.010.07.05.09.50.857
UPDRS total score52.040.559.555.042.566.50.776
HYS2.02.02.52.02.02.80.785

TremorFTMTRS part A5.03.59.05.04.07.00.919
FTMTRS part B10.09.010.512.09.513.00.502
FTMTRS part C10.08.010.59.06.011.00.810
FTMTRS total score25.021.029.025.022.028.50.918

Patient diaryON time without dyskinesia (hours)9.57.512.06.53.58.40.010
ON time with slight dyskinesia (hours)1.00.02.53.50.54.50.041
“Good” time10.57.513.510.08.013.00.670
ON time with severe dyskinesia (hours)0.50.01.00.50.01.50.612
OFF time (hours)4.53.57.54.51.511.50.778
Daytime sleeping hours0.50.01.50.50.01.00.828
Nighttime sleeping hours7.56.88.37.06.37.80.468

Nonmotor symptomsNMS section I (cardiovascular subscore)2.00.06.03.00.07.00.633
NMS section II (sleep subscore)17.011.026.020.015.026.00.993
NMS section III (mood subscore)11.03.520.012.04.525.00.907
NMS section IV (hallucinations subscore)0.00.08.00.00.04.00.974
NMS section V (memory subscore)10.03.018.512.06.021.00.523
NMS section VI (gastrointestinal subscore)4.02.07.58.04.011.00.016
NMS section VII (urinary system subscore)13.09.019.514.09.020.50.878
NMS section VIII (sexual subscore)2.00.010.02.00.05.00.197
NMS section IX (miscellaneous subscore)1.00.09.01.00.07.00.251
NMS total score85.047.0103.590.059.5115.50.939

Sleep and sleepinessPDSS-2 motor subscore3.00.07.02.01.07.00.397
PDSS-2 Parkinsonian symptoms subscore4.02.05.53.01.05.50.657
PDSS-2 disturbed sleep subscore6.03.59.57.03.511.00.334
PDSS-2 total score12.07.518.510.08.023.00.224
ESS Total7.06.012.07.05.512.00.567

DepressionBDI total score10.05.515.59.05.014.00.858
MADRS total score10.05.515.011.07.515.50.623

QoLEQ-5D0.80.70.90.80.70.90.895
EQ-VAS70.054.080.063.050.076.00.625
ADL (Schwab-England)80.075.090.080.070.090.00.965
Clinical global impression-severity3.02.04.03.01.53.50.647
Clinical global impression-improvement4.04.04.04.04.05.00.199

ADL = activities of daily living (Schwab and England Scale). BDI = Beck Depression Inventory; ESS = Epworth Sleepiness Scale; EQ-5D = the EuroQol instrument for detecting health outcome; EQ-VAS = visual analogue scale included in EQ-5D; HYS = Hoehn-Yahr Stage; FTMTRS = Fahn-Tolosa-Marin Tremor Rating Scale; MADRS = Montgomery Asberg Depression Rating Scale; NMSS = Nonmotor Symptom Assessment Scale; PDSS-2 = Parkinson’s Disease Sleep Scale 2nd version; UPDRS = Unified Parkinson’s Disease Rating Scale. For calculating significance Kruskal-Wallis test was applied except for HYS and Clinical Global Impression scales where Chi-square test was used (because of being an ordinal variable).

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