Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease

Mark F. Lew, Rajesh Pahwa, Maureen Leehey, John Bertoni, Greg Kricorian, Brian H. Avin, Vincent Calabrese, Stewart Factor, Enrico A. Fazzini, Robert A. Hauser, Jean P. Hubble, J. Thomas Hutton, Robert G. Jacoby, John Kelly, Louis C. Kirby, Jack Klapper, William Koller, Jau Shin Lou, Kenneth Marek, Patricia W. NancePaul A. Nausieda, Todd Perkins, Joel Perlmutter, John D. Rogers, Jack D. Schim, Steven M. Sergay, Kapil D. Sethi, Mathew B. Stern, Michael M. Tuchman, Cheryl E. Waters

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Objective: Patients receiving levodopa for Parkinson's disease experience motor fluctuations and immobility ('off' episodes) between doses. This study assessed adjunctive Zelaparf (selegiline orally disintegrating tablet (ODT)) for managing off episodes and for long-term safety. Methods: This open-label extension evaluated long-term safety, efficacy, and tolerability of adjunctive selegiline ODT 2.5 mg in patients who completed either of two large phase 3 double-blind studies. The study was to end after 12 months but was amended to be open-ended. Investigators could increase levodopa doses and introduce controlled-release formulations of levodopa or dopamine agonists if warranted. Additionally, results of a small randomized trial of open-label selegiline ODT 1.25 mg in comparison to conventional selegiline was added only to the safety analysis. Efficacy variables included changes in daily off time and Patient's Global Impression of Improvement (PGM) and Clinical Global Impressions Severity of Disease (CGI-S) ratings. Safety assessments included adverse events and oropharyngeal findings. Results: This study enrolled 254 patients: 248 from the large phase 3 studies (efficacy analysis) and an additional six from the prior open-label comparison (safety analysis) in order to evaluate a larger population for safety purposes. Mean reduction from baseline in daily off time was 9.4% (1.6h) for patients previously given selegiline ODT, 6.0% (1.2h) for those switched from placebo, and 8.1% (1.4h) overall. PGI-I and CGI-S ratings indicated little or no change from baseline. Treatment-related adverse events occurred in 132 (52%) patients. No severe oral irritations were attributed to selegiline ODT or prompted discontinuation. Conclusions: Long-term selegiline ODT 2.5 mg/day was effective, safe, and well tolerated in patients with Parkinson's disease experiencing off episodes during levodopa therapy.

Original languageEnglish (US)
Pages (from-to)741-750
Number of pages10
JournalCurrent Medical Research and Opinion
Volume23
Issue number4
DOIs
StatePublished - Apr 1 2007

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Selegiline
Levodopa
Tablets
Parkinson Disease
Safety
Dopamine Agonists
Double-Blind Method
Placebos
Research Personnel
Therapeutics

Keywords

  • Clinical study
  • Levodopa
  • Motor fluctuations
  • Parkinson's disease
  • Selegiline orally disintegrating tablet

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease. / Lew, Mark F.; Pahwa, Rajesh; Leehey, Maureen; Bertoni, John; Kricorian, Greg; Avin, Brian H.; Calabrese, Vincent; Factor, Stewart; Fazzini, Enrico A.; Hauser, Robert A.; Hubble, Jean P.; Hutton, J. Thomas; Jacoby, Robert G.; Kelly, John; Kirby, Louis C.; Klapper, Jack; Koller, William; Lou, Jau Shin; Marek, Kenneth; Nance, Patricia W.; Nausieda, Paul A.; Perkins, Todd; Perlmutter, Joel; Rogers, John D.; Schim, Jack D.; Sergay, Steven M.; Sethi, Kapil D.; Stern, Mathew B.; Tuchman, Michael M.; Waters, Cheryl E.

In: Current Medical Research and Opinion, Vol. 23, No. 4, 01.04.2007, p. 741-750.

Research output: Contribution to journalArticle

Lew, MF, Pahwa, R, Leehey, M, Bertoni, J, Kricorian, G, Avin, BH, Calabrese, V, Factor, S, Fazzini, EA, Hauser, RA, Hubble, JP, Hutton, JT, Jacoby, RG, Kelly, J, Kirby, LC, Klapper, J, Koller, W, Lou, JS, Marek, K, Nance, PW, Nausieda, PA, Perkins, T, Perlmutter, J, Rogers, JD, Schim, JD, Sergay, SM, Sethi, KD, Stern, MB, Tuchman, MM & Waters, CE 2007, 'Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease', Current Medical Research and Opinion, vol. 23, no. 4, pp. 741-750. https://doi.org/10.1185/030079906X167697
Lew, Mark F. ; Pahwa, Rajesh ; Leehey, Maureen ; Bertoni, John ; Kricorian, Greg ; Avin, Brian H. ; Calabrese, Vincent ; Factor, Stewart ; Fazzini, Enrico A. ; Hauser, Robert A. ; Hubble, Jean P. ; Hutton, J. Thomas ; Jacoby, Robert G. ; Kelly, John ; Kirby, Louis C. ; Klapper, Jack ; Koller, William ; Lou, Jau Shin ; Marek, Kenneth ; Nance, Patricia W. ; Nausieda, Paul A. ; Perkins, Todd ; Perlmutter, Joel ; Rogers, John D. ; Schim, Jack D. ; Sergay, Steven M. ; Sethi, Kapil D. ; Stern, Mathew B. ; Tuchman, Michael M. ; Waters, Cheryl E. / Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease. In: Current Medical Research and Opinion. 2007 ; Vol. 23, No. 4. pp. 741-750.
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abstract = "Objective: Patients receiving levodopa for Parkinson's disease experience motor fluctuations and immobility ('off' episodes) between doses. This study assessed adjunctive Zelaparf (selegiline orally disintegrating tablet (ODT)) for managing off episodes and for long-term safety. Methods: This open-label extension evaluated long-term safety, efficacy, and tolerability of adjunctive selegiline ODT 2.5 mg in patients who completed either of two large phase 3 double-blind studies. The study was to end after 12 months but was amended to be open-ended. Investigators could increase levodopa doses and introduce controlled-release formulations of levodopa or dopamine agonists if warranted. Additionally, results of a small randomized trial of open-label selegiline ODT 1.25 mg in comparison to conventional selegiline was added only to the safety analysis. Efficacy variables included changes in daily off time and Patient's Global Impression of Improvement (PGM) and Clinical Global Impressions Severity of Disease (CGI-S) ratings. Safety assessments included adverse events and oropharyngeal findings. Results: This study enrolled 254 patients: 248 from the large phase 3 studies (efficacy analysis) and an additional six from the prior open-label comparison (safety analysis) in order to evaluate a larger population for safety purposes. Mean reduction from baseline in daily off time was 9.4{\%} (1.6h) for patients previously given selegiline ODT, 6.0{\%} (1.2h) for those switched from placebo, and 8.1{\%} (1.4h) overall. PGI-I and CGI-S ratings indicated little or no change from baseline. Treatment-related adverse events occurred in 132 (52{\%}) patients. No severe oral irritations were attributed to selegiline ODT or prompted discontinuation. Conclusions: Long-term selegiline ODT 2.5 mg/day was effective, safe, and well tolerated in patients with Parkinson's disease experiencing off episodes during levodopa therapy.",
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T1 - Safety and efficacy of newly formulated selegiline orally disintegrating tablets as an adjunct to levodopa in the management of 'off' episodes in patients with Parkinson's disease

AU - Lew, Mark F.

AU - Pahwa, Rajesh

AU - Leehey, Maureen

AU - Bertoni, John

AU - Kricorian, Greg

AU - Avin, Brian H.

AU - Calabrese, Vincent

AU - Factor, Stewart

AU - Fazzini, Enrico A.

AU - Hauser, Robert A.

AU - Hubble, Jean P.

AU - Hutton, J. Thomas

AU - Jacoby, Robert G.

AU - Kelly, John

AU - Kirby, Louis C.

AU - Klapper, Jack

AU - Koller, William

AU - Lou, Jau Shin

AU - Marek, Kenneth

AU - Nance, Patricia W.

AU - Nausieda, Paul A.

AU - Perkins, Todd

AU - Perlmutter, Joel

AU - Rogers, John D.

AU - Schim, Jack D.

AU - Sergay, Steven M.

AU - Sethi, Kapil D.

AU - Stern, Mathew B.

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AB - Objective: Patients receiving levodopa for Parkinson's disease experience motor fluctuations and immobility ('off' episodes) between doses. This study assessed adjunctive Zelaparf (selegiline orally disintegrating tablet (ODT)) for managing off episodes and for long-term safety. Methods: This open-label extension evaluated long-term safety, efficacy, and tolerability of adjunctive selegiline ODT 2.5 mg in patients who completed either of two large phase 3 double-blind studies. The study was to end after 12 months but was amended to be open-ended. Investigators could increase levodopa doses and introduce controlled-release formulations of levodopa or dopamine agonists if warranted. Additionally, results of a small randomized trial of open-label selegiline ODT 1.25 mg in comparison to conventional selegiline was added only to the safety analysis. Efficacy variables included changes in daily off time and Patient's Global Impression of Improvement (PGM) and Clinical Global Impressions Severity of Disease (CGI-S) ratings. Safety assessments included adverse events and oropharyngeal findings. Results: This study enrolled 254 patients: 248 from the large phase 3 studies (efficacy analysis) and an additional six from the prior open-label comparison (safety analysis) in order to evaluate a larger population for safety purposes. Mean reduction from baseline in daily off time was 9.4% (1.6h) for patients previously given selegiline ODT, 6.0% (1.2h) for those switched from placebo, and 8.1% (1.4h) overall. PGI-I and CGI-S ratings indicated little or no change from baseline. Treatment-related adverse events occurred in 132 (52%) patients. No severe oral irritations were attributed to selegiline ODT or prompted discontinuation. Conclusions: Long-term selegiline ODT 2.5 mg/day was effective, safe, and well tolerated in patients with Parkinson's disease experiencing off episodes during levodopa therapy.

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KW - Motor fluctuations

KW - Parkinson's disease

KW - Selegiline orally disintegrating tablet

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