This trial is active, not recruiting.

Condition idiopathic parkinson's disease
Treatments cvt-301, observational cohort
Phase phase 3
Sponsor Acorda Therapeutics
Start date March 2015
End date December 2016
Trial size 365 participants
Trial identifier NCT02352363, CVT-301-005


This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
cvt-301 Inhaled levodopa
Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.
observational cohort

Primary Outcomes

Pulmonary safety within the CVT-301 treated patients, assessed by spirometry (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC] and FEV1/FVC ratio)
time frame: Over a 12-month period

Secondary Outcomes

Pulmonary safety within the observational (standard of care) cohort, assessed by spirometry FEV1, FVC and FEV1/FVC ratio.
time frame: Over a 12-month period
Difference between the CVT-301-treated patients and the observational cohort on measures of pulmonary safety
time frame: Over a 12-month period
Safety of CVT-301 measured by the number of patients with Adverse Events (AEs)
time frame: Over a 12-month period
Effect of CVT-301 on mean change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part 4 measures of motor fluctuations (dyskinesias and wearing off)
time frame: Pre-dose, at 6 and 12 months
Occurrence and severity of examiner-rated dyskinesia following CVT-301 treatment of patients experiencing an OFF episode in the clinic
time frame: Over a 12-month period
Effect of CVT-301 on carbon monoxide diffusing capacity (DLco)
time frame: Over a 12-month period

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

Inclusion Criteria: - Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed. - Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study. - Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years. - Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity. - Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period. Exclusion Criteria: - Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures. - Pregnant or lactating females or females wishing to become pregnant. - Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma. - Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation). - Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Additional Information

Official title A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Acorda Therapeutics.