Trials Sponsors Conditions Drugs Pricing

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's DiseaseMotor fluctuationslevodopainhaled drugsOff episodes

Outcome Measures

Primary Outcomes (1)

Change in average Unified Parkinson's Disease Rating Scale Part III motor score
pre-dose to 60 minutes following treatment

Secondary Outcomes (2)

Time to resolution of OFF episode to an ON state.
28 days duration outpatient treatment
To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.
change from baseline through 28 days outpatient use

Study Arms (2)

CVT-301

EXPERIMENTAL

CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.

Drug: CVT-301

Inhaled Placebo

PLACEBO COMPARATOR

Subjects randomized to receive placebo in a 1:1 randomization scheme

Drug: Placebo

Interventions

CVT-301Drug

Also known as: Levodopa Inhalation Powder

CVT-301

PlaceboDrug

Inhaled Placebo

Eligibility Criteria

Age30 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
Hoehn and Yahr Stage 1-3 in an "on" state;

Sponsors & Collaborators

Acorda Therapeutics
Industrylead

Study Sites (22)

Civitas Investigational Site 1013

Little Rock, Arkansas, 72201, United States

Civitas Investigational Site 1004

Boca Raton, Florida, 33427, United States

Civitas Investigational Site 1002

Port Charlotte, Florida, 33948, United States

Civitas Investigational Site 1015

Tampa, Florida, 33601, United States

Civitas Investigational Site 1007

Kansas City, Kansas, 66101, United States

Civitas Investigational Site 1010

Boston, Massachusetts, 02108, United States

Civitas Investigational Site 1001

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

Martin Freed, MD
Acorda Therapeutics
STUDY CHAIR

Enrollment

89 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 29, 2013

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

CVT-301

Inhaled Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

CVT-301

Inhaled Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (22)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations