Effectiveness of inhaled levodopa in Parkinson's disease

Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22984

Enrollment

Registered

2018-02-14

Start date

2018-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Ziekte van Parkinson

Interventions

Inhalation of 90 mg levodopa Oral administration of 100/25 mg orodispersible tablet levodopa/benserazide

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Contacts

Public ContactM. Luinstra

RVE klinische farmacie Van Swietenplein 1 Postbus 30033

m.luinstra@mzh.nl050-5245771

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)