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

NCT01777555 | Completed Phase 2

• 2 other identifiers: CVT-301-0032012-005822-31
• Study Type: interventional
• Target: 89
• Locations: 4 countries
• Sites: 22

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.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; Off episodes

Outcome Measures

Primary Outcomes (1)

• Change in average Unified Parkinson's Disease Rating Scale Part III motor score

  pre-dose to 60 minutes following treatment

Secondary Outcomes (2)

• Time to resolution of OFF episode to an ON state.

  28 days duration outpatient treatment

• To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.

  change from baseline through 28 days outpatient use

Study Arms (2)

CVT-301

EXPERIMENTAL

CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.

Drug: CVT-301

Inhaled Placebo

PLACEBO COMPARATOR

Subjects randomized to receive placebo in a 1:1 randomization scheme

Drug: Placebo

Interventions

CVT-301 DRUG

Also known as: Levodopa Inhalation Powder

CVT-301

Placebo DRUG

Inhaled Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (22)

Civitas Investigational Site 1013

Little Rock, Arkansas, 72201, United States

Location

Civitas Investigational Site 1004

Boca Raton, Florida, 33427, United States

Location

Civitas Investigational Site 1002

Port Charlotte, Florida, 33948, United States

Location

Civitas Investigational Site 1015

Tampa, Florida, 33601, United States

Location

Civitas Investigational Site 1007

Kansas City, Kansas, 66101, United States

Location

Civitas Investigational Site 1010

Boston, Massachusetts, 02108, United States

Location

Civitas Investigational Site 1001

Bingham Farms, Michigan, 48025, United States

Location

Civitas Investigational Site 1008

Roseville, Michigan, 48066, United States

Location

Civitas Investigational Site 1009

Saint Louis, Michigan, 48880, United States

Location

Civitas Investigational Site 1005

West Bloomfield, Michigan, 48322, United States

Location

Civitas Investigational Site 1011

Kingston, New York, 12401, United States

Location

Civitas Investigational Site 1014

Cleveland, Ohio, 44101, United States

Location

Civitas Investigational Site 1003

Kirkland, Washington, 98033, United States

Location

Civitas Investigational Site 4003

Cassino, Italy

Location

Civitas Investigational Site 4002

Chieti, Italy

Location

Civitas Investigational Site 4001

Rome, Italy

Location

Civitas Investigational Site 3001

Belgrade, Serbia

Location

Civitas Investigational Site 3002

Belgrade, Serbia

Location

Civitas Investigational Site 2004

Cambridge, United Kingdom

Location

Civitas Investigational Site 200

Glasgow, United Kingdom

Location

Civitas Investigational Site 2001

London, United Kingdom

Location

Civitas Investigational Site 2003

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Martin Freed, MD

  Acorda Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 29, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 8, 2018

Record last verified: 2015-05

Locations

IT (3); SE (2); US (13); GB (4)