Inhaled levodopa provides more rapid symptom relief than orally administered levodopa
ID
Bron
Aandoening
Parkinson's disease
Ziekte van Parkinson
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Countries of recruitment: The Netherlands
Doel van het onderzoek
Inhaled levodopa provides more rapid symptom relief than orally administered levodopa
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Inhalation of 90 mg levodopa
Oral administration of 100/25 mg orodispersible tablet levodopa/benserazide
Publiek
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Wetenschappelijk
Van Swietenplein 1
Postbus 30033
M. Luinstra
Groningen 9700 RM
The Netherlands
050-5245771
m.luinstra@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6876 |
| NTR-old | NTR7054 |
| Ander register | Regionale Toetsingscommissie Patientgebonden Onderzoek Leeuwarden : RTPO 1019 |
Samenvatting resultaten
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