Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01777555
• Date of registration: 23/01/2013
• Prospective Registration: Yes
• Primary sponsor: Acorda Therapeutics
• Public title: Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
• Scientific title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
• Date of first enrolment: April 2013
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01777555
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Italy, Serbia, United Kingdom, United States

Contacts

• Name: Martin Freed, MD
• Affiliation: Acorda Therapeutics

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;

- Hoehn and Yahr Stage 1-3 in an "on" state;

- Require levodopa-containing medication regimen at least 4 times during the waking day;

- Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
per waking day (excluding early morning "off" time) and demonstrate levodopa
responsiveness;

- Are on stable PD medication regimen.

Exclusion Criteria:

- Pregnant or lactating females;

- Previous surgery for PD or plan to have stereotactic surgery during the study period;

- History of psychotic symptoms requiring treatment, or suicide ideation or attempt
within last year;

- Adequate lung function as measured by spirometry;

- Any significant condition, severe concurrent disease, abnormality or finding that
would make patients unsuitable or may compromise patient safety.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: CVT-301

Primary Outcome(s)

Change in average Unified Parkinson's Disease Rating Scale Part III motor score [Time Frame: pre-dose to 60 minutes following treatment]

Secondary Outcome(s)

Time to resolution of OFF episode to an ON state. [Time Frame: 28 days duration outpatient treatment]

To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes. [Time Frame: change from baseline through 28 days outpatient use]

Secondary ID(s)

2012-005822-31

CVT-301-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors