The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004006-18-NL

Enrollment

Registered

2017-11-15

Start date

2018-06-07

Completion date

Unknown

Last updated

2018-06-18

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

Conditions

Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia. MedDRA version: 20.0 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 100000004852

Interventions

Product Name: Levodopa powder for inhalation Product Code: Levodopa Cyclops Pharmaceutical Form: Inhalation powder INN or Proposed INN: levodopa CAS Number: 59-92-7 Current Sponsor code: levodopa Othe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosed with Parkinson’s disease; - 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 (10 points on UPDRS III scale); - At least 2 years of levodopa use; - Able to perform spirometry; - Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

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
Main Objective: To determine the duration until maximum effect is reached of inhaled levodopa on the improvement of motor function of Parkinson's disease patients during an off period.;Secondary Objective: To determine to what extent the motor function of Parkinson's disease patients improves after inhalation of levodopa in comparison to oral levodopa. ;Primary end point(s): The UPDRS III score will be assessed pre-dose and on set time points up to 90 min post-dose as measure for motor function. The primary outcome is the time until the maximum effect on motor function (largest change in UPDRS III score) is found.;Timepoint(s) of evaluation of this end point: On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose	—

Measure

Time frame

Main Objective: To determine the duration until maximum effect is reached of inhaled levodopa on the improvement of motor function of Parkinson's disease patients during an off period.;Secondary Objective: To determine to what extent the motor function of Parkinson's disease patients improves after inhalation of levodopa in comparison to oral levodopa. ;Primary end point(s): The UPDRS III score will be assessed pre-dose and on set time points up to 90 min post-dose as measure for motor function. The primary outcome is the time until the maximum effect on motor function (largest change in UPDRS III score) is found.;Timepoint(s) of evaluation of this end point: On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome is the maximum change in UPDRS III score compared to baseline as measure for the extent of the improvement in motor function.;Timepoint(s) of evaluation of this end point: On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose	—

Countries

Netherlands

Contacts

Public ContactClinical Trial Information

Pharmaceutical Technology and Biopharmacy, University of Groningen

a.j.lexmond@rug.nl0031503633254

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026