Trial · NCT02352363

Randomized Safety Study of CVT-301 Compared to an Observational Control Group

NCT02352363, Phase 3, Completed, Acorda Therapeutics; results first posted 2018-07-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Safety Study of CVT-301 Compared to an Observational Control Group. Trials, record NCT02352363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02352363

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Safety Study of CVT-301 Compared to an Observational Control Group
NCT number: NCT02352363
Status: Completed
Phases: Phase 3
Enrollment: 408 participants, actual
Lead sponsor: Acorda Therapeutics
Conditions: Idiopathic Parkinson's Disease
Interventions: CVT-301, Observational cohort
First posted: 2015-02-02
Last updated: 2019-05-28
Results first posted: 2018-07-10

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]	Month 12 reported	To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second \[FEV1\], over a 12 month period.
Primary	Pulmonary Safety Assessed by Forced Vital Capacity [FVC].	Month 12 reported	To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).
Primary	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.	Month 12 reported	To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
Secondary	Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).	Month 12 reported	To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]	Month 12 reported	Liters	MEAN
PRIMARY	Pulmonary Safety Assessed by Forced Vital Capacity [FVC].	Month 12 reported	Liters	MEAN
PRIMARY	Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.	Month 12 reported	Ratio (%)	MEAN
SECONDARY	Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).	Month 12 reported	mL/min/mmHg	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]	CVT-301	2.778	Standard Deviation 0.7309	Liters
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]	Observational Cohort	2.767	Standard Deviation 0.8419	Liters
Pulmonary Safety Assessed by Forced Vital Capacity [FVC].	CVT-301	3.558	Standard Deviation 0.8987	Liters
Pulmonary Safety Assessed by Forced Vital Capacity [FVC].	Observational Cohort	3.642	Standard Deviation 1.0687	Liters
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.	CVT-301	78.1	Standard Deviation 6.04	Ratio (%)
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.	Observational Cohort	76.1	Standard Deviation 6.4	Ratio (%)
Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).	CVT-301	23.273	Standard Deviation 6.0025	mL/min/mmHg
Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).	Observational Cohort	23.473	Standard Deviation 7.0848	mL/min/mmHg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CVT-301	278
Overall Study	STARTED	Observational Cohort	130
Overall Study	COMPLETED	CVT-301	271
Overall Study	COMPLETED	Observational Cohort	127
Overall Study	NOT COMPLETED	CVT-301	7
Overall Study	NOT COMPLETED	Observational Cohort	3

Source ClinicalTrials.gov

Adverse events128

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	CVT-301	18	271	20
other	Nasopharyngitis	Infections and infestations	Observational Cohort	7	127	8
other	Upper respiratory tract infection	Infections and infestations	CVT-301	13	271	16
other	Upper respiratory tract infection	Infections and infestations	Observational Cohort	3	127	3
other	Bronchitis	Infections and infestations	CVT-301	7	271	7
other	Bronchitis	Infections and infestations	Observational Cohort	4	127	6
other	Influenza	Infections and infestations	CVT-301	4	271	5
other	Influenza	Infections and infestations	Observational Cohort	4	127	4
other	Dyskinesia	Nervous system disorders	CVT-301	17	271	18
other	Dyskinesia	Nervous system disorders	Observational Cohort	5	127	5

1 to 10 of 128Source ClinicalTrials.gov

See all 128 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CVT-301	1	271
Total, all-cause mortality	Observational Cohort	0	127
Total, other adverse events	CVT-301	192	271
Total, other adverse events	Observational Cohort	64	127
Total, serious adverse events	CVT-301	42	271
Total, serious adverse events	Observational Cohort	13	127

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33866196	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
CVT-301 vs Observational Cohort: deaths from any cause	Trial comparisons
CVT-301 vs Observational Cohort: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02352363

GET https://conductscience.org/api/trials/v1/NCT02352363/events?page=2

API reference For AI assistants