Evaluating the effect of inhaled levodopa (Inbrija®) for early morning off in Parkinson’s disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-06-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The aim of this study is to determine whether Inbrija® provides faster time-to-ON in individuals with PD compared with Madopar® Quick, using objective PKG-derived motor outcomes and patient-reported measures.

Main objective: To compare PKG-derived individualized time-to-ON after the morning fast-acting levodopa dose (Inbrija® vs Madopar® Quick)

Secondary objectives 4

1. To compare early-morning motor severity between Inbrija® and Madopar Quick using PKG-derived bradykinesia, dyskinesia, and activity measures.
2. To assess whether Inbrija® provides a more consistent early-morning response than Madopar® Quick, quantified as within-participant day-to-day variability in PKG-derived morning response measures.
3. To compare patient-reported symptom relief, perceived onset of action, and overall perceived effectiveness between treatments.
4. To explore whether treatment of EMO is associated with differences in motor state later in the day, as measured by PKG-derived daytime motor state metrics and relevant patient-reported outcomes.

Conditions and MedDRA coding

parkinson's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Diagnosis of idiopathic PD
2. Age ≥ 18 years
3. Clinical history suggestive of EMO, defined as worsening of PD symptoms upon awakening with delayed or insufficient morning symptom control, identified during screening using standardized EMO screening questions (Appendix 1)
4. Willingness and ability to refrain from using any fast-acting morning levodopa formulations (including Madopar® Quick and Inbrija®) during the baseline run-in period and washout period, in accordance with the protocol.
5. Able and willing to administer the assigned study drug independently or with minimal assistance upon waking.
6. Stable antiparkinsonian background medication regimen for at least 4 weeks prior to inclusion
7. Able and willing to use PKG-Watch during the full study period.
8. Able and willing to use inhaled levodopa (Inbrija®).
9. In treatment with levodopa in combination with a peripheral decarboxylase inhibitor (carbidopa or benserazide).

Exclusion criteria 5

1. Current or planned advanced PD therapies during the study period, including deep brain stimulation or continuous infusion therapies.
2. Cognitive impairment or psychiatric illness that precludes adherence as evaluated by the investigator
3. Clinically significant chronic lung disease or abnormal lung function on spirometry that may interfere with safe use of inhaled levodopa.
4. Pregnancy or breastfeeding.
5. Known allergy or intolerance to excipients in the inhaled formulation (e.g., L-leucine or to benserazide/carbidopa components).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time in minutes from completion of the assigned morning study dose (T0) to the first PKG-defined ON state per valid morning, evaluated within a 0–120-minute post-dose window and truncated at 120 minutes.

Secondary endpoints 13

1. Patient-reported time-to-ON following the morning dose
2. Overall preferred morning treatment
3. Experience with use of the treatment
4. Early-morning motor function, ease of initiating morning activities, perceived independence, and perceived confidence/security
5. Unified Parkinson’s Disease Rating Scale, Part II (MDS-UPDRS-II)
6. Parkinson’s Disease Questionnaire (PDQ-8)
7. Non-Motor Symptoms Scale (MDS-NMS-Q)
8. Proportion of PKG epochs below a fixed bradykinesia threshold (BKS < 25) within predefined post-dose windows (0–10, 0–20, 0–30, and 0–60 minutes after morning dosing)
9. Proportion of PKG epochs below the individualized threshold (BKS < θ) within the same post-dose windows
10. Early-morning physical activity and inactivity, quantified using PKG-derived activity metrics (including immobility time)
11. Pre-dose baseline motor severity during run-in, defined as the mean PKG BKS in the 10 minutes preceding the participant’s first levodopa/DDCI dose of the day.
12. Time spent in OFF, ON, and dyskinetic states over the day, expressed as the proportion of valid daytime epochs in each state. States will be defined using fixed PKG thresholds: OFF: BKS ≥ 25 ON: BKS < 25 and DKS ≤ 9 Dyskinesia: DKS > 9
13. Sleep-related PKG metrics derived from nocturnal recordings (e.g., total sleep duration, sleep efficiency, nocturnal immobility, and sleep fragmentation), summarised per night and averaged within each intervention period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Nordre Fasanvej 57

City

Frederiksberg

Postcode

2000

Country

Denmark

Scientific contact point

Organisation

Region Hovedstaden

Contact name

Bo Biering-Sørensen

Public contact point

Organisation

Region Hovedstaden

Contact name

Bo Biering-Sørensen

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications