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Correction to: Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study
Translational Neurodegeneration volume 9, Article number: 14 (2020)
Correction to: Transl Neurodegener (2020) 9:9
https://doi.org/10.1186/s40035-020-00187-1
In this published article [1], the efficacy data for the below outcomes were unfortunately not supplied based on the Full Analysis Set (FAS) at 3 and/or 6 months for specific outcomes under the statistical analysis plan (SAP). The SAP specified that the efficacy data should be based overall on the FAS at 3 months for the primary (with last observation carried forward, LOCF) and secondary (no LOCF) efficacy endpoints and 6 months for UK only (no LOCF). The amendments do not change the conclusions of the paper, and the corrected data are given below.
Clinician and patient global impressions of change
Correction to CGI-C 6-month data (UK patients only)
[ … ] For those UK patients (n = 95) who were also assessed at 6 months, 85.3% were judged as improved since commencing treatment (8.4% very much improved and 49.5% much improved) while 8.4% were judged as showing ‘no change’ and 6.4% as having worsened. [ … ]
Correction to Fig. 2b
Rating scale outcomes
Correction to UPDRS analyses (Table 2)
N numbers for UPDRS Part II were 475 at baseline and 389 at 3 months (Visit 4); results of the change from baseline analysis remain unchanged. N numbers for UPDRS Part III were 476 at baseline and 391 at 3 months; results of the change from baseline analyses remain unchanged.
Correction to Table 2.
Levodopa dosing
Correction to levodopa dosing
After 3 months of treatment with opicapone, most patients remained on the same total daily levodopa frequency (77.1% had no change, 10.4% had an increase and 12.5% had a decrease in dosing frequency), resulting in an overall mean change of approximately − 10 mg/day. […].
Discussion
Correction to discussion
[ … ] These judgements made by the investigators were corroborated by the patients themselves.
with 48.1% patients reporting they were much or very much improved after 3 months treatment with opicapone 50 mg. [ … ]
Supplementary material
Correction to Supplementary Table 2
Results of the change from baseline in perceptual problems/hallucinations was updated to 0.0 ± 2.01. Results from all other analyses remain unchanged.
Supplementary Table 2 Change from baseline in NMSS domains
NMSS domain | Mean ± SD |
---|---|
[ … ] | |
Perceptual problems/hallucinations | |
Baseline | 0.8 ± 2.45 |
Change from baseline (p value) | 0.0 ± 2.01 (p = 0.7437) |
[ … ] |
Reference
Reichmann H, Lees A, Rocha JF, Magalhães D, Soares-da-Silva P, OPTIPARK investigators. Effectiveness and safety of opicapone in Parkinson's disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener. 2020;9:9. https://doi.org/10.1186/s40035-020-00187-1.
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Reichmann, H., Lees, A., Rocha, JF. et al. Correction to: Effectiveness and safety of opicapone in Parkinson’s disease patients with motor fluctuations: the OPTIPARK open-label study. Transl Neurodegener 9, 14 (2020). https://doi.org/10.1186/s40035-020-00193-3
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DOI: https://doi.org/10.1186/s40035-020-00193-3