Het effect van inhaleerbare levodopa op het herstel van off-periodes bij patienten met de ziekte van Parkinson
Het effect van inhaleerbare levodopa op het herstel van off-periodes bij patienten met de ziekte van Parkinson
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A timed tapping test, the Timed Up & Go test and the Movement Disorders Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) score were performed pre-dose and at set time points up to 90 minutes post-dose as measures of motor function.Location evidence
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Original abstract
Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease Background Limited treatment options are available with a rapid onset of action to counter off periods in patients with Parkinson's disease (PD). Therefore, the development of rapid-onset levodopa formulations is warranted, and an inhalable formulation of levodopa is currently being investigated. Objective The aim was to determine the time to maximum effect of inhaled levodopa on the improvement of motor function in patients with Parkinson's disease during an off period. Design An open-label randomised two-way one-period crossover trial was performed. Methods Nine patients with Parkinson's disease in the 'off state' received one dose of inhaled levodopa (90 mg) and one dose of levodopa orodispersible tablet (100 mg) on two consecutive days in randomised order. A timed tapping test, the Timed Up & Go test and the Movement Disorders Society Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) score were performed pre-dose and at set time points up to 90 minutes post-dose as measures of motor function. In addition, blood samples were taken for a pharmacokinetic evaluation. Results The positive effect on the UPDRS was statistically significant 20 minutes after inhalation (compared with t = 0), the first moment at which the UPDRS procedure allows an assessment. The maximum clinical improvement in motor function after pulmonary administration was similar to that after oral administration. Inhaled levodopa was absorbed faster than oral levodopa, reaching peak plasma concentration 7 minutes after dosing, compared with 28 minutes after oral administration. The levodopa inhalation powder was well tolerated; no adverse events were observed, specifically no cough or dyspnoea, and no significant differences were found in lung function parameters. Conclusion Inhaled levodopa has a clinically meaningful effect on off periods in patients with Parkinson's disease. It appears to be a suitable fast-acting rescue therapy for patients with Parkinson's disease with motor fluctuations. Background Limited treatment options are available with a rapid onset of action to counter off periods in patients with Parkinson’s disease (PD). Therefore, the development of rapid-onset levodopa formulations is warranted, and an inhalable formulation of levodopa is currently being investigated. Objective The aim was to determine the time to maximum effect of inhaled levodopa on the improvement of motor function in patients with Parkinson’s disease during an off period. Design An open-label randomised two-way one-period crossover trial was performed. Methods Nine patients with Parkinson’s disease in the ‘off state’ received one dose of inhaled levodopa (90 mg) and one dose of levodopa orodispersible tablet (100 mg) on two consecutive days in randomised order. A timed tapping test, the Timed Up & Go test and the Movement Disorders Society Unified Parkinson’s Disease Rating Scale III (MDS-UPDRS III) score were performed pre-dose and at set time points up to 90 minutes postdose as measures of motor function. In addition, blood samples were taken for a pharmacokinetic evaluation. Results The positive effect on the UPDRS was statistically significant 20 minutes after inhalation (compared with t = 0), the first moment at which the UPDRS procedure allows an assessment. The maximum clinical improvement in motor function after pulmonary administration was similar to that after oral administration. Inhaled levodopa was absorbed faster than oral levodopa, reaching peak plasma concentration 7 minutes after dosing, compared with 28 minutes after oral administration. The levodopa inhalation powder was well tolerated; no adverse events were observed, specifically no cough or dyspnoea, and no significant differences were found in lung function parameters. Conclusion Inhaled levodopa has a clinically meaningful effect on off periods in patients with Parkinson’s disease. It appears to be a suitable fast-acting rescue therapy for patients with Parkinson’s disease with motor fluctuations.