NCT06037590

A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops® Relative to INBRIJA®

Completed Phase 1 Last updated 31 May 2025

What this trial tests

Phase 1 trial testing Levodopa Cyclops® in Parkinson in 26 participants. Completed in 27 October 2023.

Timeline

25 September 2023

Primary endpoint
20 October 2023

27 October 2023

Quick facts

Lead sponsor	PureIMS B.V.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	25 September 2023
Primary completion	20 October 2023
Estimated completion	27 October 2023
Sites	1 location across Bulgaria

Drugs / interventions tested

• Levodopa Cyclops®
• INBRIJA®

Conditions studied

• Parkinson — all drugs for Parkinson →
• Parkinson Disease — all drugs for Parkinson Disease →
• Parkinson's Disease and Parkinsonism — all drugs for Parkinson's Disease and Parkinsonism →

Sponsor

PureIMS B.V.

Who can join

Adults 18 to 55, any sex, with Parkinson or Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment.

This unmet medical need was addressed by the approval of INBRIJA®, an orally inhaled product, for producing therapeutic relief during the OFF episodes. INBRIJA® is a capsule-based inhaler system and in order to administer the full dose of levodopa, the patients need to inhale the contents of two capsules. In order to administer the full dose of levodopa, patients need to inhale the contents of two capsules. Since the INBRIJA® device is a standalone and reusable unit, the patients have to load the capsule prior to inhalation several times a day during the OFF episodes (except early-morning OFF) to get relief. Also, the INBRIJA® device is repeatedly used by PD patients and therefore needs to be properly cleaned to avoid contamination.

PureIMS is developing a more user-friendly alternative called Levodopa Cyclops®, a pre-filled drug-device combination of levodopa inhalation powder for use with the Cyclops® dry powder inhaler. Due to the nature of the Cyclops®, it offers PD patients greater ease and convenience in use. Moreover, the device's moderate to high resistance to airflow and minimal use of excipients suggests minimal cough episodes during oral inhalation.

The current study is planned in order to determine the dose at which comparative bioavailability of Levodopa Cyclops® will be reached compared to INBRIJA®.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Parkinson's Disease Drug Therapies in the Clinical Trial Pipeline: 2024 Update.
   McFarthing K, Buff S, Rafaloff G, Pitzer K, et al · · 2024 · cited 49× · PMID 39031388 · DOI 10.3233/jpd-240272
2. p53: from understanding its structure to advances in therapeutic targeting.
   Wang W, Liu X, Liu H, Abolhassani H, et al · · 2026 · PMID 41942427 · DOI 10.1038/s41392-025-02549-5
3. An In Vitro-In Vivo Comparison of Two Levodopa Dry Powder Products for Inhalation: A Randomized Trial Comparing Inbrija and Levodopa Cyclops.
   Berends JME, Wimmenhove EJ, Hoppentocht M, Hagedoorn P, et al · · 2025 · PMID 41012486 · DOI 10.3390/pharmaceutics17091149