Abstract
In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P50.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.
| Original language | English |
|---|---|
| Pages (from-to) | 1273-1280 |
| Number of pages | 8 |
| Journal | Movement Disorders |
| Volume | 29 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 01-01-2014 |
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All Science Journal Classification (ASJC) codes
- Neurology
- Clinical Neurology
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Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. / Study 018 Investigators.
In: Movement Disorders, Vol. 29, No. 10, 01.01.2014, p. 1273-1280.Research output: Contribution to journal › Article
TY - JOUR
T1 - Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease
AU - Study 018 Investigators
AU - Borgohain, Rupam
AU - Szasz, Jozsef
AU - Stanzione, Paolo
AU - Meshram, Chandrashekhar
AU - Bhatt, Mohit H.
AU - Chirilineau, Dana
AU - Stocchi, Fabrizio
AU - Lucini, Valentina
AU - Giuliani, Rodolfo
AU - Forrest, Emma
AU - Rice, Patricia
AU - Anand, Ravi
AU - Illiyas Sahadulla, M.
AU - Kardan, U.
AU - Keshava, B. S.
AU - Kishore, A.
AU - Kothari, S. S.
AU - Krishna Murthy, J. M.
AU - Kumar, S.
AU - Kumar Pal, P.
AU - Mehta, N.
AU - Prabhakar, S.
AU - Prabhakar, S. Kr
AU - Pradhan, S.
AU - Roy, A. K.
AU - Sankhla, C.
AU - Sethi, P. K.
AU - Shah, A. B.
AU - Shankar, N.
AU - Shukla, R.
AU - Sowani, A.
AU - Srinivasa, R.
AU - Varma, M.
AU - Vasudevan, D.
AU - Vavilikolanu Sreenivas, P.
AU - Velmurugendran, C. U.
AU - Vijayan, K.
AU - Bajenaru, O.
AU - Bulboaca, A.
AU - Campeanu, A.
AU - Chirileanu, D.
AU - Muresanu, D.
AU - Panea, C.
AU - Popescu, C.
AU - Simu, M.
AU - Szasz, J.
AU - Ticmeanu, M.
AU - Avarello, T.
AU - Bonuccelli, U.
AU - Eleopra, R.
PY - 2014/1/1
Y1 - 2014/1/1
N2 - In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P50.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.
AB - In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P50.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.
UR - http://www.scopus.com/inward/record.url?scp=84908473443&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84908473443&partnerID=8YFLogxK
U2 - 10.1002/mds.25961
DO - 10.1002/mds.25961
M3 - Article
VL - 29
SP - 1273
EP - 1280
JO - Movement Disorders
JF - Movement Disorders
SN - 0885-3185
IS - 10
ER -