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

Phase 2

Completed

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: Placebo; Drug: Sinemet (carbidopa/levodopa); Drug: CVT-301

• Registration Number: NCT01617135
• Lead Sponsor: Acorda Therapeutics

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhaled Placebo	Placebo	Inhaled placebo powder
Oral Sinemet (carbidopa/levodopa)	Sinemet (carbidopa/levodopa)	Open-label oral carbidopa/levodopa (CD/LD)
CVT-301 High Dose	CVT-301	CVT-High; levodopa inhalation powder (LIP)
CVT-301 Low Dose	CVT-301	CVT-Low; levodopa inhalation powder (LIP)

Primary Outcome Measures

Name	Time	Method
Safety	change from baseline up to 13 weeks	Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Civitas Clinical Site #1; 🇬🇧 Glasgow, United Kingdom

Civitas Clinical Site #2; 🇬🇧 Norwich, United Kingdom

Civitas Clinical Site #3; 🇬🇧 Newcastle, United Kingdom

Civitas Clinical Site #5; 🇮🇱 Tel Aviv, Israel

Civitas Clinical Site #4; 🇷🇸 Belgrade, Serbia

Civitas Clinical Site #7; 🇷🇸 Belgrade, Serbia

Civitas Clinical Site #6; 🇮🇱 Petach-Tikva, Israel