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

Phase 1

• 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: 20.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004006-18-NL
• Lead Sponsor: Pharmaceutical Technology and Biopharmacy, University of Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified