Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease

Rupam Borgohain, Jozsef Szasz, Paolo Stanzione, Chandrashekhar Meshram, Mohit H. Bhatt, Dana Chirilineau, Fabrizio Stocchi, Valentina Lucini, Rodolfo Giuliani, Emma Forrest, Patricia Rice, Ravi Anand, M. Illiyas Sahadulla, U. Kardan, B. S. Keshava, A. Kishore, S. S. Kothari, J. M. Krishna Murthy, S. Kumar, P. Kumar PalN. Mehta, S. Prabhakar, S. Kr Prabhakar, S. Pradhan, A. K. Roy, C. Sankhla, P. K. Sethi, A. B. Shah, N. Shankar, R. Shukla, A. Sowani, R. Srinivasa, M. Varma, D. Vasudevan, P. Vavilikolanu Sreenivas, C. U. Velmurugendran, K. Vijayan, O. Bajenaru, A. Bulboaca, A. Campeanu, D. Chirileanu, D. Muresanu, C. Panea, C. Popescu, M. Simu, J. Szasz, M. Ticmeanu, T. Avarello, U. Bonuccelli, R. Eleopra, M. Onofrj, R. Quatrale, P. Stanzione, F. Stocchi

Research output: Contribution to journalArticle

98 Citations (Scopus)

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 languageEnglish
Pages (from-to)1273-1280
Number of pages8
JournalMovement Disorders
Volume29
Issue number10
DOIs
Publication statusPublished - 2014

Fingerprint

Dyskinesias
Levodopa
Parkinson Disease
Placebos
Quality of Life
Depression
Activities of Daily Living
safinamide
Motor Activity

Keywords

  • Addon
  • Dopamine
  • Levodopa
  • Motor function
  • Parkinson's disease
  • Safinamide

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology
  • Medicine(all)

Cite this

Borgohain, R., Szasz, J., Stanzione, P., Meshram, C., Bhatt, M. H., Chirilineau, D., ... Stocchi, F. (2014). Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. Movement Disorders, 29(10), 1273-1280. https://doi.org/10.1002/mds.25961

Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. / Borgohain, Rupam; Szasz, Jozsef; Stanzione, Paolo; Meshram, Chandrashekhar; Bhatt, Mohit H.; Chirilineau, Dana; Stocchi, Fabrizio; Lucini, Valentina; Giuliani, Rodolfo; Forrest, Emma; Rice, Patricia; Anand, Ravi; Illiyas Sahadulla, M.; Kardan, U.; Keshava, B. S.; Kishore, A.; Kothari, S. S.; Krishna Murthy, J. M.; Kumar, S.; Kumar Pal, P.; Mehta, N.; Prabhakar, S.; Prabhakar, S. Kr; Pradhan, S.; Roy, A. K.; Sankhla, C.; Sethi, P. K.; Shah, A. B.; Shankar, N.; Shukla, R.; Sowani, A.; Srinivasa, R.; Varma, M.; Vasudevan, D.; Vavilikolanu Sreenivas, P.; Velmurugendran, C. U.; Vijayan, K.; Bajenaru, O.; Bulboaca, A.; Campeanu, A.; Chirileanu, D.; Muresanu, D.; Panea, C.; Popescu, C.; Simu, M.; Szasz, J.; Ticmeanu, M.; Avarello, T.; Bonuccelli, U.; Eleopra, R.; Onofrj, M.; Quatrale, R.; Stanzione, P.; Stocchi, F.

In: Movement Disorders, Vol. 29, No. 10, 2014, p. 1273-1280.

Research output: Contribution to journalArticle

Borgohain, R, Szasz, J, Stanzione, P, Meshram, C, Bhatt, MH, Chirilineau, D, Stocchi, F, Lucini, V, Giuliani, R, Forrest, E, Rice, P, Anand, R, Illiyas Sahadulla, M, Kardan, U, Keshava, BS, Kishore, A, Kothari, SS, Krishna Murthy, JM, Kumar, S, Kumar Pal, P, Mehta, N, Prabhakar, S, Prabhakar, SK, Pradhan, S, Roy, AK, Sankhla, C, Sethi, PK, Shah, AB, Shankar, N, Shukla, R, Sowani, A, Srinivasa, R, Varma, M, Vasudevan, D, Vavilikolanu Sreenivas, P, Velmurugendran, CU, Vijayan, K, Bajenaru, O, Bulboaca, A, Campeanu, A, Chirileanu, D, Muresanu, D, Panea, C, Popescu, C, Simu, M, Szasz, J, Ticmeanu, M, Avarello, T, Bonuccelli, U, Eleopra, R, Onofrj, M, Quatrale, R, Stanzione, P & Stocchi, F 2014, 'Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease', Movement Disorders, vol. 29, no. 10, pp. 1273-1280. https://doi.org/10.1002/mds.25961
Borgohain, Rupam ; Szasz, Jozsef ; Stanzione, Paolo ; Meshram, Chandrashekhar ; Bhatt, Mohit H. ; Chirilineau, Dana ; Stocchi, Fabrizio ; Lucini, Valentina ; Giuliani, Rodolfo ; Forrest, Emma ; Rice, Patricia ; Anand, Ravi ; Illiyas Sahadulla, M. ; Kardan, U. ; Keshava, B. S. ; Kishore, A. ; Kothari, S. S. ; Krishna Murthy, J. M. ; Kumar, S. ; Kumar Pal, P. ; Mehta, N. ; Prabhakar, S. ; Prabhakar, S. Kr ; Pradhan, S. ; Roy, A. K. ; Sankhla, C. ; Sethi, P. K. ; Shah, A. B. ; Shankar, N. ; Shukla, R. ; Sowani, A. ; Srinivasa, R. ; Varma, M. ; Vasudevan, D. ; Vavilikolanu Sreenivas, P. ; Velmurugendran, C. U. ; Vijayan, K. ; Bajenaru, O. ; Bulboaca, A. ; Campeanu, A. ; Chirileanu, D. ; Muresanu, D. ; Panea, C. ; Popescu, C. ; Simu, M. ; Szasz, J. ; Ticmeanu, M. ; Avarello, T. ; Bonuccelli, U. ; Eleopra, R. ; Onofrj, M. ; Quatrale, R. ; Stanzione, P. ; Stocchi, F. / Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease. In: Movement Disorders. 2014 ; Vol. 29, No. 10. pp. 1273-1280.
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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.",
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T1 - Two-Year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease

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.

AU - Onofrj, M.

AU - Quatrale, R.

AU - Stanzione, P.

AU - Stocchi, F.

PY - 2014

Y1 - 2014

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.

KW - Addon

KW - Dopamine

KW - Levodopa

KW - Motor function

KW - Parkinson's disease

KW - Safinamide

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