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

Idiopathic Parkinson's Disease Clinical Trial

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617135
• Other study ID #: CVT-301-002
• Secondary ID: 2012-000181-37
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2012
• Last updated: July 25, 2017
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2017
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• CVT-301

• Placebo

• Sinemet (carbidopa/levodopa)

• CVT-301

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Acorda Therapeutics	Michael J. Fox Foundation for Parkinson's Research

Countries where clinical trial is conducted

Israel,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function	change from baseline up to 13 weeks
Secondary	Pharmacodynamics	Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia	3 hours post-dose
Secondary	Pharmacokinetics	Serial blood draw for determination of plasma concentration-time profile	3 hours post-dose

External Links

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