Effectiveness of inhaled levodopa in Parkinson's disease
- Conditions
- Parkinson's diseaseZiekte van Parkinson
- Registration Number
- NL-OMON22984
- Lead Sponsor
- Department of Pharmaceutical Technology and Biopharmacy, Faculty of Mathematics and Natural Sciences, University of Groningen
- Brief Summary
Can Patients with Parkinson’s 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.2015.10.00
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 9
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;
Exclusion Criteria
Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
Current treatment with apomorphine or duodopa by pump;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Pharmacokinetic:<br /><br>Maximum levodopa concentration in plasma(Cmax).<br /><br>Time to maximum concentration (Tmax).<br /><br>Area under the concentration time (minutes) curve at 0-180 min (AUC0-180) after administration of the dose<br /><br>Pharmacodynamic:<br /><br>Finger tap count in 30 seconds (3.4 Finger tapping).<br /><br>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). <br />