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A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)

NCT02807675 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-01-30

No results posted yet for this study

Summary

This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's disease (PD).

Conditions

Interventions

DRUG

CVT-301, LIP

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

OTHER

Placebo

All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)

Sponsors & Collaborators

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Steven Komjathy, MD · Acorda Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807675 on ClinicalTrials.gov