AzTrials
AzTrials

Idiopathic Parkinson's DiseasePhase 3SPAN-PD™NCT02240030

Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes

A Phase 3 study testing CVT-301 Low Dose and CVT-301 High Dose in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 74 sites in 5 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 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. 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 Low Dose and CVT-301 High Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
351 participants
Where
74 sitesin 5 countries
Study dates
Nov 2014to Dec 2016
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

  • Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
  • Hoehn and Yahr Stage 1-3 in an "on" state;
  • Require levodopa-containing medication regimen at least 3 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;
  • Total daily LD dose <1600 mg/day;
  • Able to perform a spirometry maneuver in the ON and OFF states;
  • Normal cognition confirmed by MMSE score ≥25

Who cannot join

  • 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;
  • Known contraindication to the use of levodopa;
  • Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
  • Any contraindication to performing routine spirometry.

Trial locations and contacts

74 sites in 5 countries.

74 sites in 5 countries

United States55 sites

  • Acorda Site #5028

    Albany, New York, 12208

  • Acorda Site #5036

    Allentown, Pennsylvania, 18103

  • Acorda Site #5040

    Atlanta, Georgia, 30329

  • Acorda Site #5046

    Atlantis, Florida, 33462

  • Acorda Site #5053

    Aventura, Florida, 33180

  • Acorda Site #5057

    Baltimore, Maryland, 21201

  • Acorda Site #5067

    Baton Rouge, Louisiana, 70810

  • Acorda Site #5002

    Bingham Farms, Michigan, 48025

  • Acorda Site #5013

    Boca Raton, Florida, 33486

  • Acorda Site #5056

    Boston, Massachusetts, 02114

  • Acorda Site #5018

    Boston, Massachusetts, 02118

  • Acorda Site #5039

    Brooklyn, New York, 11203

  • Acorda Site #5022

    Charleston, South Carolina, 29425

  • Acorda Site #5048

    Charlotte, North Carolina, 28204

  • Acorda Site #5025

    Chicago, Illinois, 60611

  • Acorda Site #5030

    Chicago, Illinois, 60612

  • Acorda Site #5005

    Cleveland, Ohio, 44195

  • Acorda Site #5011

    Elk Grove Village, Illinois, 60007

  • Acorda Site #5042

    Fresno, California, 93710

  • Acorda Site #5064

    Fullerton, California, 92835

  • Acorda Site #5041

    Golden Valley, Minnesota, 55427

  • Acorda Site #5049

    Henrico, Virginia, 23226

  • Acorda Site #5019

    Houston, Texas, 77030

  • Acorda Site #5045

    Houston, Texas, 77030

  • Acorda Site #5016

    Jacksonville, Florida, 32209

  • Acorda Site #5003

    Kansas City, Kansas, 66160

  • Acorda Site #5051

    Kirkland, Washington, 98034

  • Acorda Site #5023

    Las Vegas, Nevada, 89102

  • Acorda Site #5035

    Loma Linda, California, 92354

  • Acorda Site #5027

    Long Beach, California, 90806

  • Acorda Site #5037

    Los Angeles, California, 90033

  • Acorda Site #5071

    Maitland, Florida, 32751

  • Acorda Site #5029

    Nashville, Tennessee, 372322551

  • Acorda Site #5031

    New York, New York, 10016

  • Acorda Site #5032

    New York, New York, 10029

  • Acorda Site #5004

    New York, New York, 10032

  • Acorda Site #5050

    Norwood, Ohio, 45212

  • Acorda Site #5044

    Orlando, Florida, 32806

  • Acorda Site #5060

    Palm Beach Gardens, Florida, 33410

  • Acorda Site #5070

    Pasadena, California, 91105

  • Acorda Site #5010

    Philadelphia, Pennsylvania, 19107

  • Acorda Site #5001

    Port Charlotte, Florida, 33952

  • Acorda Site #5062

    Portland, Oregon, 97239

  • Acorda Site #5047

    Reseda, California, 91335

  • Acorda Site #5068

    Santa Ana, California, 92705

  • Acorda Site #5020

    Scottsdale, Arizona, 85259

  • Acorda Site #5006

    St Louis, Missouri, 63110

  • Acorda Site #5065

    St. Petersburg, Florida, 33713

  • Acorda Site #5038

    Syracuse, New York, 13210

  • Acorda Site #5012

    Tampa, Florida, 33613

  • Acorda Site #5069

    Torrance, California, 90505

  • Acorda Site #5059

    Virginia Beach, Virginia, 23456

  • Acorda Site #5052

    Washington D.C., District of Columbia, 20007

  • Acorda Site #5014

    West Bloomfield, Michigan, 48322

  • Acorda Site #5058

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Poland8 sites

  • Acorda Site #5304

    Katowice, 40588

  • Acorda Site #5306

    Krakow, 30349

  • Acorda Site #5303

    Krakow, 30510

  • Acorda Site #5307

    Krakow, 31505

  • Acorda Site #5302

    Lodz, 90130

  • Acorda Site #5308

    Warsaw, 00453

  • Acorda Site #5301

    Warsaw, 01868

  • Acorda Site #5305

    Zaspa, 80462

Other trials in Poland

Spain6 sites

  • Acorda Site #5404

    Barcelona, 08026

  • Acorda Site #5406

    Barcelona, 08035

  • Acorda Site #5405

    Madrid, 28006

  • Acorda Site #5407

    Pamplona, Navarre, 31008

  • Acorda Site #5403

    San Sebastián, 20009

  • Acorda Site #5401

    Sant Cugat del Vallès, 08190

Other trials in Spain

Canada3 sites

  • Acorda Site #5103

    London, Ontario, N6A5A5

  • Acorda Site #5104

    Ottawa, Ontario, K1Y4E9

  • Acorda Site #5105

    Toronto, Ontario, M5T2S8

Other trials in Canada

Czechia2 sites

  • Acorda Site #5201

    Prague, 10000

  • Acorda Site #5203

    Prague, 14000

Other trials in Czechia

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

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.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Being tested
CVT-301 Low Dose, CVT-301 High Dose, Placebo
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-301 Low DoseDrug

    Also called Inhaled levodopa

  • CVT-301 High DoseDrug

    Also called Inhaled levodopa

  • PlaceboOther

    Also called Inhalation-grade lactose

Study groups in NCT02240030
Study groupRoleWhat they receive
CVT-301 Low DoseExperimentalCapsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Receives: Drug: CVT-301 Low Dose
CVT-301 High DoseExperimentalCapsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Receives: Drug: CVT-301 High Dose
PlaceboPlacebo comparatorCapsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Receives: Other: Placebo

What is being measured

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

  1. Unified Parkinson's Disease Rating Scale (UPDRS) Part III

    Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

    Measured: 30 minutes post-dose at week 12

Secondary outcomes (5)

  1. Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.

    Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed

    Measured: at week 12

  2. UPDRS Part III Motor Score at 20 Minutes

    Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

    Measured: at week 12

  3. Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12

    Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.

    Measured: week 12

  4. UPDRS Part III at 10 Min.

    Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.

    Measured: week 12

  5. PD Patient Diary

    Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.

    Measured: post week 12

Timeline

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

  1. First posted15 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240030
Sponsor's protocol ID
CVT-301-004
Acronym
SPAN-PD™
Status last verified
May 2019
First submitted
11 Sep 2014
Last updated
28 May 2019
Data monitoring committee
Yes

Publications

  • LeWitt PA, Hauser RA, Pahwa R, Isaacson SH, Fernandez HH, Lew M, Saint-Hilaire M, Pourcher E, Lopez-Manzanares L, Waters C, Rudzinska M, Sedkov A, Batycky R, Oh C; SPAN-PD Study Investigators. Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2019 Feb;18(2):145-154. doi: 10.1016/S1474-4422(18)30405-8.

    PubMed 30663606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CVT-301 Low Dose and CVT-301 High Dose in people with Idiopathic Parkinson's Disease, run by Acorda Therapeutics at 74 sites in 5 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 8 inclusion and 6 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 74 sites in United States, Poland, Spain, Canada, Czechia. 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. Some participants in this study may receive a placebo. 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 17 Apr 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?

Unified Parkinson's Disease Rating Scale (UPDRS) Part III (time frame: 30 minutes post-dose at week 12). 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 NCT02240030, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in