|- candidate number||22965|
|- NTR Number||NTR5435|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-okt-2015|
|- Secondary IDs||ParkinsonDPI-2 |
|- Public Title||Inhalation of Levodopa in Parkinson's disease|
|- Scientific Title||Pharmacokinetic evaluation of a pulmonary administered levodopa dry powder formulation in Parkinsonís disease.|
|- hypothesis||A more rapid rise of the levodopa plasma level after inhalation compared to oral administration of levodopa.|
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease|
|- Inclusion criteria||Signed informed consent.|
Diagnosed with Parkinsonís disease
At least 18 years old.
Currently on stable Parkinsonís disease levodopa regimen.
Require levodopa containing medication regimen with a maximum of 4 administrations a day.
Able to perform spirometry
|- Exclusion criteria||Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent.|
Pregnant or breast feeding.
Active pulmonary disease.
Patients with known symptomatic orthostatic hypotension.
The use of COMT inhibitors and/or MAO-B inhibitors.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2016|
|- planned closingdate||1-jul-2017|
|- Target number of participants||8|
|- Interventions||First visit: inhalation of 30 mg levodopa inhalation powder.|
Second visit: inhalation of 60 mg levodopa inhalation powder.
Third visit: regular oral levodopa medication.
During all three visits, the participants undergo spirometry (lung function testing) and multiple bloodsamples are drawn.
|- Primary outcome||Maximum levodopa concentration in plasma(Cmax).|
Time to maximum concentration (Tmax).
Area under the concentration time (minutes) curve at 0-180 min (AUC0-180) after administration of the dose (related to the actual dose administered, weighed dose minus remained dose in inhaler after inhalation).
|- Secondary outcome||Absorption rate constant (Ka) of levodopa after pulmonary administration.|
Terminal elimination half life (T1/2el) of levodopa after pulmonary administration.
Decrease of FEV1 in percentage measured by spirometry (at predose, 35 and 100 minutes after administration.
Number of participants with adverse events (both spontaneously reported and reported as a result of questioning by the researcher.
|- Timepoints||3 visits: at least 1 week between 2 visits and all visits within 6 months.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M. Luinstra|
|- CONTACT for SCIENTIFIC QUERIES|| M. Luinstra|
|- Sponsor/Initiator ||Department of Pharmaceutical Technology and Biopharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen|
(Source(s) of Monetary or Material Support)
|- Publications||Can Patients with Parkinsonís Disease Use Dry Powder Inhalers during Off Periods?
M. Luinstra, A. W. F. Rutgers, H. Dijkstra et al. Published: July 14, 2015. DOI: 10.1371/journal.pone.0132714
A levodopa dry powder inhaler for the treatment of Parkinson's disease patients in off periods. M. Luinstra, F. Grasmeijer, P. Hagedoorn et al. Eur J Pharm Biopharm. 2015 Oct 7. pii: S0939-6411(15)00404-X. doi: 10.1016/j.ejpb.2015.10.003
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||12-okt-2015 - 22-jun-2016|