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Parkinson's DiseasePhase 3STRIDE-PDNCT00099268

Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

A Phase 3 study testing Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa in people with Parkinson's Disease, run by Novartis Pharmaceuticals at 73 sites in 14 countries.

Completed

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

Official record
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Trial summary

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
747 participants
Where
73 sitesin 14 countries
Study dates
Sep 2004to Nov 2008
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of idiopathic Parkinson's disease
  • Diagnosis of Parkinson's disease for no more than 5 years

Who cannot join

  • History, signs, or symptoms of atypical or secondary parkinsonism
  • Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
  • Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
  • Other inclusion/exclusion criteria applied to this study.

Trial locations and contacts

73 sites in 14 countries.

73 sites in 14 countries

United States31 sites

  • Parkinson's Disease and Movement Disorder Center of Albany Medical

    Albany, New York, 12208

  • Wesley Woods Health Center

    Atlanta, Georgia, 30329

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Parkinson's Disease and Movement Disorder Center

    Boca Raton, Florida, 33486

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Parkinson's Disease and Movement Disorders Center of Long Island

    Commack, New York, 11725

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9016

  • Duke University Medical Center Movement Disorders Center

    Durham, North Carolina, 27705

  • Baylor College of Medicine, Parkinson's Disease Center

    Houston, Texas, 77030

  • Landon Center on Aging

    Kansas City, Kansas, 66160

  • Coastal Neurological Medical Group

    La Jolla, California, 92037

  • Keck School of Medicine, Division of Movement Disorders

    Los Angeles, California, 90033

  • Reed Neurological Research Center

    Los Angeles, California, 90095-1769

  • Semmes-Murphey Clinic

    Memphis, Tennessee, 38104

  • University of Miami

    Miami, Florida, 33136

  • Wisconsin Institute for Neurologic and Sleep Disorders

    Milwaukee, Wisconsin, 53233

  • Molecular NeuroImaging, LLC

    New Haven, Connecticut, 06510

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University, Neurological Institute

    New York, New York, 10032-3784

  • Pennsylvania Neurology Institute

    Philadelphia, Pennsylvania, 19107

  • Charlotte Neurological Service

    Port Charlotte, Florida, 33952

  • University of Rochester

    Rochester, New York, 14618

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Clinical Neuroscience Center

    Southfield, Michigan, 48034

  • The Parkinson's Institute

    Sunnyvale, California, 94085

  • University of South Florida

    Tampa, Florida, 33606

  • NeuroHealth, Inc.

    Warwick, Rhode Island, 02886

Other trials in United States

Italy6 sites

  • Novartis Investigative Site

    Catania

  • Novartis Investigative Site

    Chieti Scalo

  • Novartis Investigative Site

    Lido di Camaiore

  • Novartis Investigative Site

    Naples

  • Novartis Investigative Site

    Pozzilli

  • Novartis Investigative Site

    Roma

Other trials in Italy

Finland5 sites

  • Novartis Investigative Site

    Helsinki

  • Novartis Investigative Site

    Kuopio

  • Novartis Investigative Site

    Mikkeli

  • Novartis Investigative Site

    Oulu

  • Novartis Investigative Site

    Pori

Other trials in Finland

Germany5 sites

  • Novartis Investigative Site

    Berlin

  • Novartis Investigative Site

    Bochum

  • Novartis Investigative Site

    Dresden

  • Novartis Investigative Site

    Marburg

  • Novartis Investigative Site

    Tübingen

Other trials in Germany

Canada4 sites

  • Novartis Investigative Site

    Edmonton, Alberta

  • Novartis Investigative Site

    London, Ontario

  • Novartis Investigative Site

    Montreal, Quebec

  • Novartis Investigative Site

    Toronto, Ontario

Other trials in Canada

France4 sites

  • Novartis Investigative Site

    Lille

  • Novartis Investigative Site

    Nantes

  • Novartis Investigative Site

    Paris

  • Novartis Investigative Site

    Toulouse

Other trials in France

Sweden4 sites

  • Novartis Investigative Site

    Jönköping

  • Novartis Investigative Site

    Linköping

  • Novartis Investigative Site

    Norrköping

  • Novartis Investigative Site

    Stockholm

Other trials in Sweden

United Kingdom4 sites

  • Novartis Investigative Site

    Birmingham

  • Novartis Investigative Site

    Glasgow

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Newcastle upon Tyne

Other trials in United Kingdom

Belgium2 sites

  • Novartis Investigative Site

    Antwerp

  • Novartis Investigative Site

    Bruges

Other trials in Belgium

Greece2 sites

  • Novartis Investigative Site

    Ioannina

  • Novartis Investigative Site

    Thessaloniki

Other trials in Greece

Spain2 sites

  • Novartis Investigative Site

    Barcelona

  • Novartis Investigative Site

    Madrid, 28035

Other trials in Spain

Switzerland2 sites

  • Novartis Investigative Site

    Lausanne

  • Novartis Investigative Site

    Zurich

Other trials in Switzerland

Austria1 site

  • Novartis Investigative Site

    Innsbruck

Other trials in Austria

Turkey (Türkiye)1 site

  • Novartis Investigative Site

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Being tested
Carbidopa/levodopa/entacapone, Immediate release carbidopa/levodopa
Keywords
Parkinson's disease, levodopa therapy, dyskinesia
Medical subject headings
Parkinson Disease, Dyskinesias

What participants receive

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

  • Carbidopa/levodopa/entacaponeDrug

    Also called Stalevo

    Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.

  • Immediate release carbidopa/levodopaDrug

    Also called Sinemet

    Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Study groups in NCT00099268
Study groupRoleWhat they receive
Carbidopa/levodopa/entacaponeExperimentalPatients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Receives: Drug: Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopaActive comparatorPatients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Receives: Drug: Immediate release carbidopa/levodopa

What is being measured

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

  1. Time to First Occurrence of Dyskinesia

    Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.

    Measured: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first

Secondary outcomes (5)

  1. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)

    The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.

    Measured: Baseline, Week 6 and Week 130

  2. Occurrence of Wearing-off

    Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.

    Measured: Baseline to Week 134

  3. Time to First Occurrence of Wearing-off

    Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.

    Measured: Baseline to end of study (134-208 weeks of treatment)

  4. Occurrence of Dyskinesia

    Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?"

    Measured: Baseline to Week 208

  5. Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)

    The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.

    Measured: Baseline to Week 156

Timeline

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

  1. First posted10 Dec 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099268
Sponsor's protocol ID
CELC200A2401
Acronym
STRIDE-PD
Status last verified
Apr 2012
First submitted
10 Dec 2004
Last updated
23 Apr 2012

Publications

  • Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060.

    PubMed 20582993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa in people with Parkinson's Disease, run by Novartis Pharmaceuticals at 73 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 2 inclusion and 4 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Italy, Finland, Germany, Canada 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 8 Mar 2011). 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?

Time to First Occurrence of Dyskinesia (time frame: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first). 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 NCT00099268, 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 23 Apr 2012.

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