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Evaluating the effect of inhaled levodopa (Inbrija®) for early morning off in Parkinson’s disease
EU CTIS ID: 2026-526465-18-00
What this study is testing
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)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of idiopathic PD
- Age ≥ 18 years
- 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)
- 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.
- Able and willing to administer the assigned study drug independently or with minimal assistance upon waking.
- Stable antiparkinsonian background medication regimen for at least 4 weeks prior to inclusion
You likely can't join if
- Current or planned advanced PD therapies during the study period, including deep brain stimulation or continuous infusion therapies.
- Cognitive impairment or psychiatric illness that precludes adherence as evaluated by the investigator
- Clinically significant chronic lung disease or abnormal lung function on spirometry that may interfere with safe use of inhaled levodopa.
- Pregnancy or breastfeeding.
- Known allergy or intolerance to excipients in the inhaled formulation (e.g., L-leucine or to benserazide/carbidopa components).
See the full eligibility criteria
- Diagnosis of idiopathic PD
- Age ≥ 18 years
- 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)
- 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.
- Able and willing to administer the assigned study drug independently or with minimal assistance upon waking.
- Stable antiparkinsonian background medication regimen for at least 4 weeks prior to inclusion
- Able and willing to use PKG-Watch during the full study period.
- Able and willing to use inhaled levodopa (Inbrija®).
- In treatment with levodopa in combination with a peripheral decarboxylase inhibitor (carbidopa or benserazide).
- Current or planned advanced PD therapies during the study period, including deep brain stimulation or continuous infusion therapies.
- Cognitive impairment or psychiatric illness that precludes adherence as evaluated by the investigator
- Clinically significant chronic lung disease or abnormal lung function on spirometry that may interfere with safe use of inhaled levodopa.
- Pregnancy or breastfeeding.
- Known allergy or intolerance to excipients in the inhaled formulation (e.g., L-leucine or to benserazide/carbidopa components).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.