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

• ClinicalTrials.gov Identifier: NCT01777555
• Recruitment Status: Completed
• First Posted: January 29, 2013
• Last Update Posted: August 8, 2018
• Sponsor: Acorda Therapeutics
• Information provided by (Responsible Party): Acorda Therapeutics

Tracking Information

• First Submitted Date: January 23, 2013
• First Posted Date: January 29, 2013
• Last Update Posted Date: August 8, 2018
• Study Start Date: April 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 28, 2013): Change in average Unified Parkinson's Disease Rating Scale Part III motor score [ Time Frame: pre-dose to 60 minutes following treatment ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01777555 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: January 28, 2013)

• 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 ]
  Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes
• Official 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)
• Brief Summary: This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Parkinson's Disease

Intervention

• Drug: CVT-301
  Other Name: Levodopa Inhalation Powder
• Drug: Placebo

Study Arms

• Experimental: CVT-301
  CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.
  Intervention: Drug: CVT-301
• Placebo Comparator: Inhaled Placebo
  Subjects randomized to receive placebo in a 1:1 randomization scheme
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2014): 89
• Original Estimated Enrollment (submitted: January 28, 2013): 80
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy, Serbia, United Kingdom, United States

Administrative Information

• NCT Number: NCT01777555
• Other Study ID Numbers: CVT-301-003; 2012-005822-31 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Acorda Therapeutics
• Study Sponsor: Acorda Therapeutics
• Collaborators: Not Provided

Investigators

• Study Chair: Martin Freed, MD; Acorda Therapeutics

• PRS Account: Acorda Therapeutics
• Verification Date: May 2015