Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson’s disease

Hauser, Robert A; Slawek, Jaroslaw; Barone, Paolo; Dohin, Elisabeth; Surmann, Erwin; Asgharnejad, Mahnaz; Bauer, Lars

doi:10.1186/s12883-016-0610-7

BMC Neurology

Table 2 Mean change from baseline to End of Maintenance/End of Treatment for secondary efficacy variables (Full Analysis Set)

From: Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson’s disease

Assessment (possible score range)^a	Mean ± SD baseline score			LS mean ± SE change from baseline			LS mean (95 % CI) difference to placebo
Assessment (possible score range)^a	Placebo (n = 40)	Rotigotine low dose (n = 36)	Rotigotine high dose (n = 40)	Placebo (n = 40)	Rotigotine low dose (n = 36)	Rotigotine high dose (n = 40)	Rotigotine low dose (n = 36)	Rotigotine high dose (n = 40)
Secondary efficacy variables
AS as rated by caregiver (0–42)^b	18.4 ± 8.1	19.3 ± 6.2	19.6 ± 6.9	−2.50 ± 1.97	−5.71 ± 2.30	−5.55 ± 2.05	−3.20 (−8.17, 1.76) p = 0.200	−3.04 (−8.19, 2.10) p = 0.239
PDQ-8 total (0–100)^b	29.1 ± 20.1	27.3 ± 18.3	31.6 ± 18.1	−3.29 ± 2.42	−5.37 ± 2.54	−8.34 ± 2.39	−2.09 (−8.48, 4.31) p = 0.519	−5.06 (−11.29, 1.17) p = 0.111
NMSS “mood/apathy” domain (0–72)^c	13.5 ± 10.7	15.8 ± 11.2	15.6 ± 11.8	−4.84 ± 1.41	−8.46 ± 1.50	−8.72 ± 1.37	−3.62 (−7.39, 0.15) p = 0.060	−3.88 (−7.46, −0.30) p = 0.034
SHAPS (0–14)^b	1.6 ± 2.1	2.1 ± 2.4	2.1 ± 2.5	−1.09 ± 0.29	−1.48 ± 0.31	−1.08 ± 0.29	−0.38 (−1.16, 0.40) p = 0.334	0.02 (−0.74, 0.77) p = 0.968
BDI-II total (0–63)^c	12.8 ± 7.0	13.9 ± 7.2	12.0 ± 5.8	−2.66 ± 0.93	−2.50 ± 1.00	−2.99 ± 0.90	0.16 (−2.34, 2.66) p = 0.899	−0.33 (−2.68, 2.03) p = 0.785
UPDRS Part III in “ON” (0–108)^b	27.5 ± 14.0	31.6 ± 10.7	27.0 ± 8.4	−3.13 ± 1.50	−8.09 ± 1.55	−7.96 ± 1.49	−4.96 (−8.91, −1.01) p = 0.014	−4.83 (−8.63, −1.03) p = 0.013
Post hoc analysis of single items from NMSS “mood/apathy” domain
Item 7: Lost interest in surroundings (0–12)	2.2 ± 2.1	2.5 ± 2.5	2.6 ± 3.0	−1.12 ± 0.306	−1.78 ± 0.325	−1.64 ± 0.297	−0.66 (−1.48, 0.16) p = 0.1137	−0.52 (−1.30, 0.25) p = 0.1839
Item 8: Lost interest in doing things (0–12)	3.7 ± 3.1	3.9 ± 2.7	4.4 ± 3.4	−0.96 ± 0.465	−1.97 ± 0.495	−2.41 ± 0.452	−1.01 (−2.25, 0.23) p = 0.1093	−1.45 (−2.63, −0.26) p = 0.0173
Item 11: Has flat moods (0–12)	1.7 ± 1.9	2.7 ± 2.6	2.6 ± 3.2	−1.11 ± 0.283	−1.43 ± 0.301	−1.61 ± 0.274	−0.32 (−1.08, 0.45) p = 0.4110	−0.49 (−1.22, 0.23) p = 0.1785
Item 12: Difficulty experiencing pleasure (0–12)	2.7 ± 3.3	2.6 ± 2.9	2.2 ± 2.2	−0.97 ± 0.342	−1.78 ± 0.365	−1.31 ± 0.332	−0.81 (−1.72, 0.11) p = 0.0823	−0.34 (−1.21, 0.53) p = 0.4411
Combined score of the 4 apathy items: 7, 8, 11, and 12 (0–48)	10.3 ± 7.9	11.7 ± 8.3	11.8 ± 9.5	−3.97 ± 0.979	−7.11 ± 1.043	−7.06 ± 0.952	–3.14 (−5.76, −0.51) p = 0.0196	−3.09 (−5.58, −0.60) p = 0.0156
Item 9: Feels nervous, worried for no reason (0–12)	1.0 ± 1.5	1.7 ± 2.1	1.8 ± 3.0	−0.23 ± 0.324	−0.01 ± 0.345	−0.46 ± 0.315	0.22 (−0.65, 1.09) p = 0.6129	−0.23 (−1.06, 0.60) p = 0.5785
Item 10: Seems sad or depressed (0–12)	2.3 ± 3.3	2.4 ± 3.1	2.1 ± 2.6	−0.75 ± 0.400	−1.23 ± 0.427	−1.14 ± 0.390	−0.48 (−1.55, 0.59) p = 0.3757	−0.38 (−1.40, 0.63) p = 0.4568

^aHigher scores indicate worse ratings for all assessments
^bData are reported as mean change from baseline to End of Maintenance, with last observation carried forward
^cData are reported as mean change from Baseline to End of Treatment (combined data from End of Maintenance visit and Early Withdrawal visit), and reported as observed cases
AS: Apathy Scale; BDI-II: Beck Depression Inventory Second Edition; CI: confidence interval; LS: least squares; NMSS: Non-Motor Symptoms Scale; PDQ-8: 8-item Parkinson’s Disease Questionnaire; SHAPS: Snaith–Hamilton Pleasure Scale; SD: standard deviation; SE: standard error; UPDRS: Unified Parkinson’s Disease Rating Scale

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ISSN: 1471-2377

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