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NCT Number: NCT01777555

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

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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Civitas Investigational Site 4003, Cassino, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVT-301

Drug

Other names: Levodopa Inhalation Powder

Placebo

Drug

Primary outcomes

  1. Change in average Unified Parkinson's Disease Rating Scale Part III motor score

    Time frame: pre-dose to 60 minutes following treatment

Secondary outcomes

  1. Time to resolution of OFF episode to an ON state.

    Time frame: 28 days duration outpatient treatment

  2. 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

    Adverse experiences, ECGs, vital signs, clinical laboratory evaluation, pulmonary function using spirometry

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2013
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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