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

• Register: EUCTR
• Last refreshed on: 18 June 2018
• Main ID: EUCTR2017-004006-18-NL
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: Pharmaceutical Technology and Biopharmacy, University of Groningen
• Public title: The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease
• Scientific title: 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
• Date of first enrolment: 07/06/2018
• Target sample size: 8
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004006-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Clinical Trial Information
• Affiliation: Pharmaceutical Technology and Biopharmacy, University of Groningen

• Name: Clinical Trial Information
• Affiliation: Pharmaceutical Technology and Biopharmacy, University of Groningen

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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
Other descriptive name: LEVODOPA
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 60-90

Trade Name: Madopar 125 mg, orodispersible tablet
Pharmaceutical Form: Orodispersible tablet

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose

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.

Secondary Outcome(s)

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

Secondary ID(s)

ParkinsonDPI-3

Source(s) of Monetary Support

Parkinson Vereniging

Martini Ziekenhuis Groningen

University of Groningen