Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

July 25, 2017 updated by: Acorda Therapeutics

A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations ("Off Episodes")

The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson's Disease patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson's medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Civitas Clinical Site #6
      • Tel Aviv, Israel
        • Civitas Clinical Site #5
  • Serbia
      • Belgrade, Serbia
        • Civitas Clinical Site #4
      • Belgrade, Serbia
        • Civitas Clinical Site #7
  • United Kingdom
      • Glasgow, United Kingdom
        • Civitas Clinical Site #1
      • Newcastle, United Kingdom
        • Civitas Clinical Site #3
      • Norwich, United Kingdom
        • Civitas Clinical Site #2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVT-301 Low Dose
CVT-Low; levodopa inhalation powder (LIP)
Drug: CVT-301
Experimental: CVT-301 High Dose
CVT-High; levodopa inhalation powder (LIP)
Drug: CVT-301
Placebo Comparator: Inhaled Placebo
Inhaled placebo powder
Drug: Placebo
Active Comparator: Oral Sinemet (carbidopa/levodopa)
Open-label oral carbidopa/levodopa (CD/LD)
Drug: Sinemet (carbidopa/levodopa)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: change from baseline up to 13 weeks
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
change from baseline up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics
Time Frame: 3 hours post-dose
Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
3 hours post-dose
Pharmacokinetics
Time Frame: 3 hours post-dose
Serial blood draw for determination of plasma concentration-time profile
3 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Collaborators

Michael J. Fox Foundation for Parkinson's Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-301-002
  • 2012-000181-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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