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Idiopathic Parkinson's DiseasePhase 3NCT02352363

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

A Phase 3 study testing CVT-301 and Observational cohort in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 76 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD… Read more about this study

Who is it for?
Ages 30 to 85 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
CVT-301 and Observational cohort
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
76 sitesin 14 countries
Study dates
Mar 2015to May 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
  • Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
  • Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
  • Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
  • Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.

Who cannot join

  • Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
  • Pregnant or lactating females or females wishing to become pregnant.
  • Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
  • Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
  • Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Trial locations and contacts

76 sites in 14 countries.

76 sites in 14 countries

United States14 sites

  • Acorda Site #7133

    Atlanta, Georgia, 30342

  • Acorda Site #7134

    Atlanta, Georgia, 30342

  • Acorda Site #7150

    Baton Rouge, Louisiana, 70810

  • Acorda Site #7131

    Decatur, Georgia, 30033

  • Acorda Site #7140

    Des Moines, Iowa, 50309

  • Acorda Site # 7142

    Fountain Valley, California, 92708

  • Acorda Site #7138

    Honolulu, Hawaii, 96734

  • Acorda Site #7137

    Ormond Beach, Florida, 32174

  • Acorda Site #7139

    Panorama City, California, 91402

  • Acorda Site #7145

    Scottsdale, Arizona, 85258

  • Acorda Site #7135

    St. Petersburg, Florida, 33713

  • Acorda Site #7141

    Sunnyvale, California, 94085

  • Acorda Site #7130

    Sunrise, Florida, 33351

  • Acorda Site #7148

    Toledo, Ohio, 43614

Other trials in United States

Germany9 sites

  • Acorda Site #7041

    Achim, 28832

  • Acorda Site #7043

    Beelitz-Heilstätten, 14547

  • Acorda Site #7049

    Berlin, 12163

  • Acorda Site #7050

    Bochum, 44791

  • Acorda Site #7048

    Bremerhaven, 27574

  • Acorda Site #7047

    Cologne, 50937

  • Acorda Site #7046

    Marburg, 35043

  • Acorda Site #7042

    Munich, 80804

  • Acorda Site #7044

    Ulm, 89081

Other trials in Germany

Spain9 sites

  • Acorda Site #7116

    Barcelona, 08026

  • Acorda Site #7111

    Barcelona, 08028

  • Acorda Site #7120

    Barcelona, 08035

  • Acorda Site #7119

    Barcelona, 08036

  • Acorda Site #7113

    Burgos, 09006

  • Acorda Site #7115

    Donostia / San Sebastian, 20009

  • Acorda Site #7118

    Madrid, 28006

  • Acorda Site #7114

    Madrid, 28046

  • Acorda Site #7112

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

Poland8 sites

  • Acorda Site #7085

    Gdansk, 80-462

  • Acorda Site #7084

    Katowice, 40-588

  • Acorda Site #7083

    Kracow, 08026

  • Acorda Site #7086

    Krakow, 30-349

  • Acorda Site #7087

    Krakow, 31-505

  • Acorda Site #7082

    Lodz, 90-130

  • Acorda Site #7081

    Warsaw, 01-868

  • Acorda Site #7088

    Warsaw, 02-097

Other trials in Poland

France7 sites

  • Acorda Site #7036

    Amiens, 80054Cedex1

  • Acorda Site #7037

    Bordeaux, 33000

  • Acorda Site #7034

    Marseille, 13385

  • Acorda Site #7031

    Montpellier, 34295

  • Acorda Site #7033

    Nîmes, 30029

  • Acorda Site #7032

    Strasbourg, 67098

  • Acorda Site #7035

    Toulouse, 31059

Other trials in France

Czechia5 sites

  • Acorda Site #7024

    Choceň, 12163

  • Acorda Site #7025

    Ostrava, 70852

  • Acorda Site #7021

    Pardubice, 27574

  • Acorda Site #7022

    Prague, 10000

  • Acorda Site #7023

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Romania5 sites

  • Acorda Site #7094

    Brasov, 500283

  • Acorda Site #7092

    Brasov, 500365

  • Acorda Site #7093

    Bucharest, 12051

  • Acorda Site #7091

    Constanța, 900591

  • Acorda Site #7095

    Târgu Mureş, 540136

Other trials in Romania

Israel4 sites

  • Acorda Site #7062

    Jerusalem, 91120

  • Acorda Site #7064

    Petah Tikva, 49100

  • Acorda Site #7061

    Ramat Gan, 5265601

  • Acorda Site #7063

    Tel Aviv, 64239

Other trials in Israel

Austria3 sites

  • Acorda Site #7004

    Innsbruck, 64239

  • Acorda Site #7002

    Linz, 04021

  • Acorda Site #7003

    Vienna, 01220

Other trials in Austria

Belgium3 sites

  • Acorda Site #7011

    Brussels, 01200

  • Acorda Site #7012

    Edegem, B-2650

  • Acorda Site #7013

    Ghent, 09000

Other trials in Belgium

Serbia3 sites

  • Acorda Site #7101

    Belgrade, 11000

  • Acorda Site #7102

    Belgrade, 11000

  • Acorda Site #7103

    Kragujevac, 34000

Other trials in Serbia

United Kingdom3 sites

  • Acorda Site #7123

    Cambridge, CB2 0QQ

  • Acorda Site #7121

    Glasgow, G51 4TF

  • Acorda Site #7122

    London, W6 8RF

Other trials in United Kingdom

Hungary2 sites

  • Acorda Site #7053

    Budapest, 01033

  • Acorda Site #7051

    Budapest, 01135

Other trials in Hungary

Netherlands1 site

  • Acorda Site #7045

    The Hague, 83527

Other trials in Netherlands

About this study

Official title: A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

Read the detailed description

A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.

Being tested
CVT-301, Observational cohort
Keywords
Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVT-301Drug

    Also called Inhaled levodopa

  • Observational cohortOther

Study groups in NCT02352363
Study groupRoleWhat they receive
CVT-301ExperimentalCapsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Receives: Drug: CVT-301
Observational CohortOtherStandard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.
Receives: Other: Observational cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]

    To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.

    Measured: Month 12 reported

  2. Pulmonary Safety Assessed by Forced Vital Capacity [FVC].

    To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).

    Measured: Month 12 reported

  3. Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.

    To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).

    Measured: Month 12 reported

Secondary outcomes (1)

  1. Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).

    To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.

    Measured: Month 12 reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352363
Sponsor's protocol ID
CVT-301-005
Status last verified
May 2019
First submitted
26 Jan 2015
Last updated
28 May 2019
Data monitoring committee
Yes

Publications

  • Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.

    PubMed 33866196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CVT-301 and Observational cohort in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 76 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Germany, Spain, Poland, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1] (time frame: Month 12 reported). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352363, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.

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