Parkinson's DiseasePhase 4NCT00642356

Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

A Phase 4 study testing Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa in people with Parkinson's Disease, run by Novartis at 21 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have Parkinson's disease. Read more about this study

Who is it for?: Ages 30 to 85 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: 14 participants
Where: 21 sitesUnited States
Study dates: Mar 2008to May 2009
Phase: Phase 4
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

Be aged 30 to 85 years.
Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

Who cannot join

Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
Have unstable Parkinson's Disease requiring frequent booster doses;
Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
Have a history or current diagnosis of psychotic features according to the investigator;
Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

South Coast Health Center
Aliso Viejo, California, 92656
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Neurology, Inc
Columbia, Missouri, 65201
Parkinson's Disease & Movement Disorders
Commack, New York, 11725
University of Texas Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27705
Sunrise Clinical Research, Inc
Hollywood, Florida, 33021
University of Texas Medical School
Houston, Texas, 77030
University of California
Irvine, California, 92697
Coastal Neurological Medical Group, Inc
La Jolla, California, 92037
Neurology Associates
Monroeville, Pennsylvania, 15146
Creighton U Medical Center, Dept of Neurology
Omaha, Nebraska, 68131
Xenoscience, Inc
Phoenix, Arizona, 85004
University of Pittsburg
Pittsburgh, Pennsylvania, 15213
Charlotte Neurological Services
Port Charlotte, Florida, 33952
Dr. John's Mercy Medical Center
St Louis, Missouri, 63141
Central New York Research Corporation
Syracuse, New York, 13210
Neurological Care of Central NY
Syracuse, New York, 13210
Scott & White Hospital
Temple, Texas, 76508
Cotton O'Neil Clinic
Topeka, Kansas, 66606
Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off

Conditions: Parkinson's Disease
Being tested: Carbidopa/levodopa/entacapone, Immediate release carbidopa/levodopa
Keywords: Idiopathic Parkinson's disease, carbidopa/levodopa/entacapone, non-motor symptoms, motor-symptoms
Medical subject headings: Parkinson Disease

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 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.
Immediate release carbidopa/levodopaDrug
Immediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.

Study groups in NCT00642356
Study group	Role	What they receive
Carbidopa/levodopa/entacapone	Experimental	Not described Receives: Drug: Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa	Active comparator	Not described Receives: Drug: Immediate release carbidopa/levodopa

What is being measured

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

Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.
Measured: Baseline to 15 minutes prior to 2nd dose at Week 8

Secondary outcomes (1)

Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 5 motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the motor subscale of the QWOQ-9 is 0 to 20. A higher score indicates greater disability. A negative change score indicates improvement.
Measured: Baseline to 15 minutes prior to 2nd dose at Week 8

Timeline

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

Mar 2008May 2009

First posted25 Mar 2008 (estimated)
Study startMar 2008
Primary completionMay 2009
Study completionMay 2009

Why it stopped: slow enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642356
Sponsor's protocol ID: CELC200AUS14
Status last verified: Feb 2011
First submitted: 19 Mar 2008
Last updated: 18 Feb 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
ClinicalTrials.gov ID: NCT00642356
Acronym / sponsor ID: CELC200AUS14
Conditions: Parkinson's Disease
Keywords: Idiopathic Parkinson's disease, carbidopa/levodopa/entacapone, non-motor symptoms, motor-symptoms
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow enrollment
Enrolment: 14 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Posted 11 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
Carbidopa/levodopa/entacapone	Experimental	Drug: Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa	Active comparator	Drug: Immediate release carbidopa/levodopa

Who may qualify

Ages: 30 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Be aged 30 to 85 years.
Be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol.
Have a clinical diagnosis of idiopathic Parkinson's Disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia)
Have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of Parkinson's Disease which improves with the next immediate release (IR) carbidopa/levodopa dose as determined by the Quantitative Wearing-Off Questionnaire 9 and investigator's assessment. At least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (IR) carbidopa/levodopa administration. Also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled)
Be taking a stable dose of immediate release (IR) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (IR) carbidopa/levodopa between 300 to 800 mg. Dosing should be either 3 to 6 times per day.

Key exclusion criteria (6 listed)

Have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization;
Have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism;
Have unstable Parkinson's Disease requiring frequent booster doses;
Disabling dyskinesias, indicated by a score of greater than 1 on Unified Parkinson Disease Rating Scale question #32, or a score of greater than 1 on Unified Parkinson Disease Rating Scale question #33;
Have a history or current diagnosis of psychotic features according to the investigator;

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
Carbidopa/levodopa/entacaponeAlso: Stalevo®Carbidopa/levodopa/entacapone 25/100/200 mg tablets plus placebo immediate release carbidopa/levodopa capsules, administered orally for 8 weeks. Total daily dosage and frequency of dosing for each patient was determined by the investigator and stabilized upon entry into the study.	Drug	Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopaImmediate release carbidopa/levodopa 25/100 mg capsules plus placebo carbidopa/levodopa/entacapone tablets, administered orally for 8 weeks. The maximum daily dose is 800 mg. Total daily dosage and frequency of dosing for each patient was determined by the investigator.	Drug	Immediate release carbidopa/levodopa

Primary outcome

Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Time frame: Baseline to 15 minutes prior to 2nd dose at Week 8
The QWOQ-9 is a self-rated questionnaire used to assess motor and non-motor symptoms of Parkinson's disease. The 4 non-motor symptoms are each measured on a five item (0-4) Likert scale, reflecting the severity of the item from "not present" to "very severe". The range of possible score values of the non-motor subscale of the QWOQ-9 is 0 to 16. A higher score indicates greater disability. A negative change score indicates improvement.

1 secondary outcome

Change From Baseline on the Motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)
Time frame: Baseline to 15 minutes prior to 2nd dose at Week 8

Results and safety

Results posted to the registry on 11 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carbidopa/Levodopa/Entacapone	7	5
Immediate Release Carbidopa/Levodopa	7	4

Primary outcome: Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9)

Time frame: Baseline to 15 minutes prior to 2nd dose at Week 8. Mean (Standard Deviation). Unit: Units on a scale

Measure	Carbidopa/Levodopa/Entacapone n = 7	Immediate Release Carbidopa/Levodopa n = 5
Value	-0.9 (0.90)	-0.2 (2.49)

Population analysed: All subjects that were assessed for efficacy

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carbidopa/Levodopa/Entacapone	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Immediate Release Carbidopa/Levodopa	0 of 7 (0%)	1 of 7 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carbidopa/levodopa/entacapone and Immediate release carbidopa/levodopa in people with Parkinson's Disease, run by Novartis at 21 sites in United States.

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 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: stopped early, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 11 Jan 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?

Change From Baseline on the Non-motor Score of the Quantitative Wearing-Off Questionnaire 9 Item (QWOQ-9) (time frame: Baseline to 15 minutes prior to 2nd dose at Week 8). 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 NCT00642356.

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 18 Feb 2011.