Effects of inhaled CVT-301 in Subjects with Parkinson’s disease
Research type
Research Study
Full title
A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control
IRAS ID
166630
Contact name
Nicola Pavese
Contact email
Sponsor organisation
Civitas Therapeutics, Inc.
Eudract number
2014-003799-22
Duration of Study in the UK
2 years, 3 months, 7 days
Research summary
This study will compare the safety and effects of a drug called Levodopa administered in a different way (inhaled rather than ingested as per standard of care). This will be given for the treatment of up to 5 OFF episodes (times of sudden loss of muscle control and onset of Parkinson symptoms) per day in Parkinsons Disease (PD) participants experiencing muscle fluctuations (OFF episodes) with their standard oral medications.
Each treated episode will require 2-capsule inhalations of Levodopa inhalation powder (CVT-301) (i.e., 2 capsules used in the inhaler per treated episode) to deliver the dose.
To enable comparison, the study will include a simultaneous observational group of PD participants who will be managed using the usual standards of care (i.e. oral medications).
The study is open-label, meaning that the study team and the participants will know whether they are receiving CVT-301 or the normal standard of care.
Participants may have been previously enrolled in the previous CVT-301-002 or CVT-301-003 studies, or may have never taken CVT-301. Participants who were previously enrolled in the CVT-301-002 and CVT-301-003 studies will be assigned to the CVT-301 treatment group (CVT-301 at a dose of 50 mg levodopa [LD] fine particle dose [FPD]), in this study.
Participants who have never taken CVT-301 will be randomized in a 2:1 ratio to the CVT-301 treatment group (CVT-301 at a dose of 50 mg LD FPD) or the observational group.
The study is expected to last 12-months and will take place in approximately 65 sites across Europe. The study is being funded by Civitas Therapeutics, Inc.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1427
Date of REC Opinion
19 Dec 2014
REC opinion
Favourable Opinion