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

Phase 2

Completed

• Conditions: parkinsonism; Parkinson's disease; 10028037

• Registration Number: NL-OMON55857
• Lead Sponsor: Martini Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

- Diagnosed with Parkinson*s disease;
- At least 18 years of age;
- Predictable off periods totalling *2 h per waking day despite PD medications,
including oral levodopa taken at least four times daily;
- Recognisable off periods for themselves and others;
- Sufficiently large (measurable) difference between on and off state
- At least 2 years of levodopa use;
- At least 4 weeks on a stable medication scheme prior to inclusion;
- 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;
- Prolonged QT-interval;
- Pregnancy or breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the time until maximum effect on motor function. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome is the maximum change in MDS-UPDRS III score as<br /><br>pseudo-quantitative measure for the clinical improvement in motor function.<br /><br>Additionally, a secondary study outcome is the levodopa blood profile after<br /><br>inhalation of 90 mg levodopa in comparison to 100/25 mg orally administered<br /><br>levodopa/benserazide. Pharmacokinetic parameters that will be derived from the<br /><br>concentration vs. time curve are tmax, Cmax and AUC0-180. </p><br>