Parkinson's DiseasePhase 3NCT00134966
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
A Phase 3 study testing capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) in people with Parkinson's Disease, run by Novartis at 60 sites in 8 countries.
Trial summary
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 60 sitesin 8 countries
- Study dates
- Aug 2005to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis
- Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
- Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment
Who cannot join
- History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
- History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
- Diagnosis of Parkinson's disease for more than 5 years prior to Screening
- Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline
- Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
Trial locations and contacts
60 sites in 8 countries.
60 sites in 8 countries
Canada18 sites
Heritage Medical Research Clinic
Calgary, Alberta, T2N 4N1
Neuro Rive Sud
Greenfield Park, Quebec, J4V 2J2
Neurology Division, Health Science Center
Halifax, Nova Scotia, B3J 3T1
Eastern Health Care - Health Sciences Centre, Neurology Department
HSC Room 5317, 300 Prince Philip Drive, Saint John's, Newfoundland and Labrador, A1B 3V6
Grand River Hospital
Kitchener, Ontario, N2H 5Z8
London Health Sciences Center, University Hospital, Rm. A10-026
London, Ontario, N6A 5A5
Centre for Movement Disorders
Markham, Ontario, L6B 1C9
Study site
Moncton, New Brunswick, E1C 2M4
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Unite des Troubles du Mouvement Andre-Barbeau, CHUM-Hotel-Dieu
Montreal, Quebec
Parkinson's & Neurodegenerative Disorders Clinic
Ottawa, Ontario, K1G 4G3
Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Quebec Memory and Motor Skills Disorders Clinic
Québec, G1R 3X5
Dr. Felix Veloso Research
Regina, Saskatchewan, S4T 1A5
University of Saskatchewan, Royal University Hospital
Saskatoon, S7N 0W8
Centre de Recjerche Clinique du CHUS
Sherbrooke, Quebec, J1H 5N4
Cape Breton Regional Hospital, Neurology Department
Sydney, Nova Scotia, B1P 1P3
Hiren Desai Medicine Professional Corporation
Windsor, Ontario, N8X 5A6
United States17 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Coastal Neurology, PA
Beaufort, South Carolina, 29902
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, 15601
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, 77030
University of Florida Health Science Center
Jacksonville, Florida, 32209
Mayo Clinic
Jacksonville, Florida, 32224
Coastal Neurological Medical Group, Inc
La Jolla, California, 92037
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
Phoenix, Arizona, 85013
Neurosearch, Inc.
Reseda, California, 91335
Blue Ridge Research Center at Roanoke Neurological Center
Roanoke, Virginia, 24014
Neurology Associates
San Marcos, Texas, 78666
Clinical Neuroscience Center
Southfield, Michigan, 48034
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104
USF Medical Clinic
Tampa, Florida, 33612
NeuroHealth
Warwick, Rhode Island, 02886
Melbourne Internal Medicine Associates
Westlake, Ohio, 44145
Lankenau Hospital
Wynnewood, Pennsylvania, 19096-3425
Italy8 sites
"Dipartimento di Neuroscienze Oftalmologia e Genetica (DINOG)
Università Degli Studi Di Genova, Via de Toni 5, Genova, 16132
A.O. Istituti Clinici di Perfezionamento-Unita'Operativa Centro Parkinson
Via Bignami 1, Milan, 20126
Istituto Nazionale Neurologico "Carlo Besta"
Via Celoria 11, Milano, 20100
Dipartimento di Neuroscienze-Università degli Studi di Torino
Via Cherasco 15, Torino, 10126
Unità Operativa Complessa Neurologia - Policlinico Universitario "G. Martino"
Via Consolare Valeria, Messina, 98125
Dipartimento di Neuroscienze-Sezione Neurologia Università degli Studi di Pisa- AO S. Chiara
Via Roma, 67, Pisa, 56127
Clinica Neurologica I - Azienda Ospedaliera-Universitaria Policlinico - Università di Catania
Via Santa Sofia 78, Catania, 95123
Dipartimento di Scienze Neurologiche Università degli Studi di Roma "La Sapienza" Roma I
Viale dell'Università 30, Roma, 00185
Czechia4 sites
FN-neurologická klinika
Alej Svobody 80, Plzeň, 304 60
Neurologická klinika, Univerzita Palackého
I.P.Pavlova 6, Olomouc, 775 20
Neurologicka klinika
Katerinska 12, Praha 2, 12000
FN-Nemocnice Pardubice
Kyjevska 44, Pardubice, 53000
Israel4 sites
Dep. Of Neurology (Bitan 38, EEG institute)
Dep. of Neurology, Zerifin, 70300
Rambam Medical Center
Haliya Hashniya 8, Haifa District, 31096
Belinson Campus, Jabotinsky st. Movement Disorder Unit
Petah Tikva, 49100
Sourasky Medical Center
Weitzman Saint Movement Disorder Clinic, Tel Aviv, 64239
Poland3 sites
Samodzielny Publiczny Szpital Kliniczny Oddzial Kliniczny Neurologii i Epiletologii
Ul. Czerniakowska 231, Warszawa, 00-416
Centrum Neurologii Klinicznej
Ul. Dwernickiego 8, Krakow, 31-530
Klinika Neruologii Wieku Podeszlego
ul.Medykow 14, Katowice, 40-752
Portugal3 sites
Hospitais da Universidade de Coimbra (Serv. Neurologia)
Avenida Bissaya Barreto, Coimbra, 3000-075
Hospital de Santa Maria (Serv. Neurologia)
Avenida Professor Egas Moniz, Lisbon, 1649-035
Hospital de Santo António (Serv. Neurologia)
Largo Professor Abel Salazar, Porto, 4099-001
Turkey (Türkiye)3 sites
Hacettepe Medical School, Department of Neurology
Hacettepe Universitesi Hastaneleri Norooji AD Sihhiye, Ankara, 6,100
Istanbul CAPA Medical School
Istanbul University CAPA Medical School, Dept. of Neurology, Istanbul, 34610
Dokuz Eylul Medical School, Department of Neurology
Noroloji Anabilim Dali Inciralti Izmir, Izmir, 35340
About this study
Official title: A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
Read the detailed description
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
- Conditions
- Parkinson's Disease
- Being tested
- capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
- Keywords
- Parkinson's disease, levodopa, 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.
capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)Drug
Also called Stalevo, CELC200
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) |
| 2 | Active comparator | Not described Receives: Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom control change from baseline to week 39
Secondary outcomes (4)
Change from baseline to week 39 in activities of daily living
Change from baseline to week 39 in motor function
Change from baseline to week 39 in mental acuity
Change from baseline to week 39 in incidence of dyskinesia and wearing off
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134966
- Sponsor's protocol ID
- CELC200A2305
- Status last verified
- May 2017
- First submitted
- 23 Aug 2005
- Last updated
- 17 May 2017
- Results posted
- No
Publications
Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343.
PubMed 19058133
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa
- ClinicalTrials.gov ID
- NCT00134966
- Acronym / sponsor ID
- CELC200A2305
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, levodopa, dyskinesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
Detailed description
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) |
| 2 | Active comparator | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis
- Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
- Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment
Key exclusion criteria (5 listed)
- History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
- History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
- Diagnosis of Parkinson's disease for more than 5 years prior to Screening
- Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline
- Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)Also: Stalevo, CELC200 | Drug | 1, 2 |
Primary outcome
Symptom control change from baseline to week 39
4 secondary outcomes
Change from baseline to week 39 in activities of daily living
Change from baseline to week 39 in motor function
Change from baseline to week 39 in mental acuity
Change from baseline to week 39 in incidence of dyskinesia and wearing off
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 19058133Hauser RA, Panisset M, Abbruzzese G, Mancione L, Dronamraju N, Kakarieka A; FIRST-STEP Study Group. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease. Mov Disord. 2009 Mar 15;24(4):541-50. doi: 10.1002/mds.22343.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) in people with Parkinson's Disease, run by Novartis at 60 sites in 8 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 3 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Canada, United States, Italy, Czechia, Israel and 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptom control change from baseline to week 39. 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 NCT00134966, 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 17 May 2017.