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

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CVT-301
Placebo
Sinemet (carbidopa/levodopa)
CVT-301
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Motor fluctuations, levodopa, inhaled drugs, Motor fluctuation ("off episodes")

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Civitas Clinical Site #6
  • Civitas Clinical Site #5
  • Civitas Clinical Site #4
  • Civitas Clinical Site #7
  • Civitas Clinical Site #1
  • Civitas Clinical Site #3
  • Civitas Clinical Site #2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

CVT-301 Low Dose

CVT-301 High Dose

Inhaled Placebo

Oral Sinemet (carbidopa/levodopa)

Arm Description

CVT-Low; levodopa inhalation powder (LIP)

CVT-High; levodopa inhalation powder (LIP)

Inhaled placebo powder

Open-label oral carbidopa/levodopa (CD/LD)

Outcomes

Primary Outcome Measures

Safety
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function

Secondary Outcome Measures

Pharmacodynamics
Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
Pharmacokinetics
Serial blood draw for determination of plasma concentration-time profile

Full Information

First Posted
May 7, 2012
Last Updated
July 25, 2017
Sponsor
Acorda Therapeutics
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT01617135
Brief Title
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
Official Title
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")
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's disease, Motor fluctuations, levodopa, inhaled drugs, Motor fluctuation ("off episodes")

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVT-301 Low Dose
Arm Type
Experimental
Arm Description
CVT-Low; levodopa inhalation powder (LIP)
Arm Title
CVT-301 High Dose
Arm Type
Experimental
Arm Description
CVT-High; levodopa inhalation powder (LIP)
Arm Title
Inhaled Placebo
Arm Type
Placebo Comparator
Arm Description
Inhaled placebo powder
Arm Title
Oral Sinemet (carbidopa/levodopa)
Arm Type
Active Comparator
Arm Description
Open-label oral carbidopa/levodopa (CD/LD)
Intervention Type
Drug
Intervention Name(s)
CVT-301
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sinemet (carbidopa/levodopa)
Intervention Type
Drug
Intervention Name(s)
CVT-301
Primary Outcome Measure Information:
Title
Safety
Description
Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function
Time Frame
change from baseline up to 13 weeks
Secondary Outcome Measure Information:
Title
Pharmacodynamics
Description
Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia
Time Frame
3 hours post-dose
Title
Pharmacokinetics
Description
Serial blood draw for determination of plasma concentration-time profile
Time Frame
3 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Civitas Clinical Site #6
City
Petach-Tikva
Country
Israel
Facility Name
Civitas Clinical Site #5
City
Tel Aviv
Country
Israel
Facility Name
Civitas Clinical Site #4
City
Belgrade
Country
Serbia
Facility Name
Civitas Clinical Site #7
City
Belgrade
Country
Serbia
Facility Name
Civitas Clinical Site #1
City
Glasgow
Country
United Kingdom
Facility Name
Civitas Clinical Site #3
City
Newcastle
Country
United Kingdom
Facility Name
Civitas Clinical Site #2
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://foxtrialfinder.michaeljfox.org/
Description
Related Info

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

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