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Continuous Levodopa Delivery with an Intraoral Micropump System: An Open-Label Pharmacokinetics and Clinical Study.
Olanow, C Warren; McIntyre, Deborah; Matarazzo, Michele; Leinonen, Mika; McGarry, Andrew; Kamp, Cornelia; Kennedy, Julie; Torti, Margherita; Kruger, Rejko; Obeso, José A; Stocchi, Fabrizio; Heller, Ephraim; Kieburtz, Karl.
Afiliación
  • Olanow CW; Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA.
  • McIntyre D; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Matarazzo M; Luxembourg Institute of Health, Transversal Translational Medicine, Strassen, Luxembourg.
  • Leinonen M; Centro Integral de Neurociencias AC (CINAC), Hospital Universitario HM Puerta del Sur, Fundación de Investigación HM Hospitales, Madrid, Spain.
  • McGarry A; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Kamp C; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Kennedy J; Cooper Medical School of Rowan University, Camden, New Jersey, USA.
  • Torti M; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Kruger R; Center for Health & Technology, University of Rochester, Rochester, New York, USA.
  • Obeso JA; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Stocchi F; Clintrex Research Corporation, Sarasota, Florida, USA.
  • Heller E; Luxembourg Institute of Health, Transversal Translational Medicine, Strassen, Luxembourg.
  • Kieburtz K; CEU San Pablo University Madrid; Network Center for Biomedical Research in Neurodegenerative Diseases, Madrid, Spain.
Mov Disord ; 39(6): 945-954, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38698639
ABSTRACT

BACKGROUND:

Double-blind studies have demonstrated that motor complications in Parkinson's disease (PD) can be reduced with continuous delivery of levodopa. The DopaFuse system is a novel, intraoral micropump that attaches to a retainer and uses a propellant to deliver levodopa/carbidopa (LD/CD) continuously into the mouth.

OBJECTIVES:

Evaluate the safety, pharmacokinetics, and efficacy of LD/CD delivered via the DopaFuse system compared to treatment with intermittent doses of standard oral LD/CD in PD patients with motor fluctuations.

METHODS:

This was a 2-week, open-label study (NCT04778176) in 16 PD patients treated with ≥4 levodopa doses/day and experiencing motor fluctuations. On Day 1 (clinic setting) patients received their usual dose of standard LD/CD; DopaFuse therapy was initiated on Day 2, and on Day 3 patients received DopaFuse plus a morning oral LD/CD dose. Patients returned home on Days 4-14 and returned for in-clinic assessment on Day 15.

RESULTS:

Continuous DopaFuse delivery of LD/CD was associated with reduced variability in plasma levodopa levels compared to oral LD/CD (mean ± SD levodopa Fluctuation Index reduced from 2.15 ± 0.59 on Day1 to 1.50 ± 0.55 on Day 2 (P = 0.0129) and to 1.03 ± 0.53 on Day 3 (P < 0.0001)). This pharmacokinetic improvement translated into significantly reduced OFF time with DopaFuse therapy (reduction of -1.72 ± 0.37 h at Day 15; P = 0.0004) and increased ON time without severe dyskinesias (increase of 1.72 ± 0.37 h at Day 15; P = 0.0004) versus oral LD/CD administration. DopaFuse therapy was not associated with any clinically significant adverse events.

CONCLUSIONS:

Continuous delivery of LD/CD using the DopaFuse system was associated with significantly less variability in plasma levodopa concentrations and reductions in OFF time compared to treatment with standard oral LD/CD therapy and was well tolerated. © 2024 International Parkinson and Movement Disorder Society.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de Parkinson / Carbidopa / Levodopa / Antiparkinsonianos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Mov Disord Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedad de Parkinson / Carbidopa / Levodopa / Antiparkinsonianos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Mov Disord Asunto de la revista: NEUROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos