No registrations found.
ID
Source
Health condition
Parkinson's disease
Ziekte van Parkinson
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time until maximum effect on motor function (maximum change from baseline), determined by the MDS-UPDRS III test scores 3.3 Rigidity, 3.4 Finger tapping, 3.9 Arising from chair, and 3.10 Gait.
Secondary outcome
Pharmacokinetic:
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
Pharmacodynamic:
Finger tap count in 30 seconds (3.4 Finger tapping).
The time it takes the patient to get up from a chair, walk 10 meters, turn around and walk back 10 meters (3.9 and 3.10 combined in timed up-and-go test).
Background summary
Countries of recruitment: The Netherlands
Study objective
Inhaled levodopa provides more rapid symptom relief than orally administered levodopa
Study design
Time points motor function tests: t = -1, 10, 20, 30, 40, 50, 60, 75, 90 min
Time points blood sampling: t = -1, 5, 10, 15, 20, 30, 45, 60, 75, 90, 180 min
Intervention
Inhalation of 90 mg levodopa
Oral administration of 100/25 mg orodispersible tablet levodopa/benserazide
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Inclusion criteria
Diagnosed with Parkinson’s disease according to the UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria;
At least 18 years of age;
Predictable off periods;
Recognisable off periods for themselves and others;
Sufficiently large (measurable) difference between on and off state (at least 10 points on the UPDRS III scale);
At least 2 years of levodopa use;
Morning levodopa dose equivalent to 100 mg levodopa;
Able to perform spirometry;
Signed informed consent.
Exclusion criteria
Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
Current treatment with apomorphine or duodopa by pump;
Severe off periods during the night;
Current or past experience with depression/depressed mood;
Known symptomatic orthostatic hypotension;
Active pulmonary disease;
Pregnancy or breast-feeding.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6876 |
| NTR-old | NTR7054 |
| Other | Regionale Toetsingscommissie Patientgebonden Onderzoek Leeuwarden : RTPO 1019 |
Summary results
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.2015.10.00