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

This study is not yet open for participant recruitment.
Verified January 2013 by Civitas Therapeutics
Sponsor:
Information provided by (Responsible Party):
Civitas Therapeutics
ClinicalTrials.gov Identifier:
NCT01777555
First received: January 23, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
 Drug: CVT-301
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Levodopa
U.S. FDA Resources

Further study details as provided by Civitas Therapeutics:

Primary Outcome Measures:
  • Change in average Unified Parkinson's Disease Rating Scale Part III motor score [ Time Frame: pre-dose to 60 minutes following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of OFF episode to an ON state. [ Time Frame: 28 days duration outpatient treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry


Estimated Enrollment: 80
Study Start Date: April 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: CVT-301
Other Name: Levodopa Inhalation Powder
Placebo Comparator: Inhaled Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777555

Contacts
Contact: Tia DeFeo-Fraulini, MS 617-660-4141 tia@civitastherapeutics.com

Sponsors and Collaborators
Civitas Therapeutics
  More Information

No publications provided

Responsible Party: Civitas Therapeutics
ClinicalTrials.gov Identifier: NCT01777555     History of Changes
Other Study ID Numbers: CVT-301-003, 2012-005822-31
Study First Received: January 23, 2013
Last Updated: January 28, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Italy: The Italian Medicines Agency

Keywords provided by Civitas Therapeutics:
Parkinson's Disease
Motor fluctuations
levodopa
inhaled drugs
Off episodes

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013