AzTrials
AzTrials

Parkinson's DiseasePhase 4NCT00391898

Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

A Phase 4 study testing Levodopa/carbidopa/entacapone and Levodopa/carbidopa in people with Parkinson's Disease, run by Novartis at 26 sites in Spain.

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

The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa 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?
Levodopa/carbidopa/entacapone and Levodopa/carbidopa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
26 sitesSpain
Study dates
Oct 2006to Jun 2008
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients ages ≥ 30 and ≤ 80 years old.
  • A clinical diagnosis of idiopathic Parkinson's disease.
  • Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
  • Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
  • 1 full tablet, and/or
  • 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
Show all 11Show fewer
  • Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
  • Must have a minimum UPDRS part II (ADL) score of 9.
  • Patients without dyskinesia or with mild dyskinesia.
  • Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
  • Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Who cannot join

  • Previous or current use of entacapone.
  • History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
  • Unstable Parkinson's disease patients.
  • Patients who experience severe dyskinesia.
  • The following levodopa/carbidopa doses and strengths are not permitted:
  • Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
Show all 14Show fewer
  • Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
  • Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
  • Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
  • Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
  • Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
  • Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
  • Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
  • Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Spain26 sites

  • Hospital Juan Canalejo

    A Coruña, 15002

  • Hospital Universitario Principe de Asturias

    Alcalá de Henares, Madrid, 28805

  • Fundación Hospital de Alcorcón

    Alcorcón (Madrid, 28922

  • Hospital General de Alicante

    Alicante, 03010

  • Centro Médico Teknon

    Barcelona, 08022

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08025

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Corporació Sanitària Parc Taulí Sabadell

    Barcelona, 08208

  • Hospital General Yagüe

    Burgos, 09005

  • Policlínica Gipuzkoa

    Donostia / San Sebastian, 20009

  • Hospital Universitario Virgen de las Nieves

    Granada, 18012

  • Hospital Universitari Bellvitge Princeps d'Espanya

    L'Hospitalet de Llobregat , Barcelona, 08907

  • Clínica Ruber

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Universitaria de Navarra

    Pamplona, 31008

  • Hospital General de Catalunya

    Sant Cugat Del Valles, Barcelona, 08195

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario de la Fe

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Gral. de Valencia

    Valencia, 46014

Other trials in Spain

About this study

Official title: A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa

The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa

Being tested
Levodopa/carbidopa/entacapone, Levodopa/carbidopa
Keywords
Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
Medical subject headings
Parkinson Disease

What participants receive

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

  • Levodopa/carbidopa/entacaponeDrug

    Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.

  • Levodopa/carbidopaDrug

    Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Study groups in NCT00391898
Study groupRoleWhat they receive
Levodopa/carbidopa/entacaponeExperimentalNot described
Receives: Drug: Levodopa/carbidopa/entacapone
Levodopa/carbidopaActive comparatorNot described
Receives: Drug: Levodopa/carbidopa

What is being measured

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

  1. Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3

    The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.

    Measured: Baseline to end of study (Month 3)

Secondary outcomes (6)

  1. Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3

    The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part I (items 1-4; total score 0-16, calculated as the sum of the individual items) measures the patient's mentation, mood and behavior. A lower total score indicates greater symptom control. A negative change score indicates improvement.

    Measured: Baseline to end of study (Month 3)

  2. Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3

    The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part III (items 18-31; total score 0-56, calculated as the sum of the individual items) measures the patient's motor function. A lower total score indicates greater symptom control. A negative change score indicates improvement.

    Measured: Baseline to end of study (Month 3)

  3. Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3

    Part IV of the UPDRS measures complications the patient may be experiencing with therapy and was only collected at and after the visit at which the first dyskinesia or episode of wearing-off was recorded. Part IV is composed of 3 sections and 11 items: A (32-35, dyskinesia), B (36-39, clinical fluctuations, C (40-42, other complications) (total score 0-23, calculated as the sum of the individual items). A lower total score indicates greater symptom control. A negative change score indicates improvement.

    Measured: Baseline to end of study (Month 3)

  4. Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3

    The PDQ-39 is an instrument 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, cognitions, 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 195. A lower score indicates better quality of life. A positive change score indicates an improvement.

    Measured: Baseline to end of study (Month 3)

  5. Patient and Investigator Global Evaluation of the Patient

    Both the patient and the investigator made an evaluation of the change in the patient's condition by rating the condition of the patient at the end of the study compared to patient's condition at baseline. The rating was made on a scale ranging from -3 to +3: (-3: Very much improved, -2: much improved, -1: mild improvement, 0: no change, +1: mild deterioration, +2: much deterioration, +3: very much deterioration). A negative score indicates improvement.

    Measured: Baseline to end of study (Month 3)

  6. Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3

    The QQ is a self-administered questionnaire that includes 19 wearing-off (WO) symptoms (motor and non-motor). A positive answer to each of the 19 symptoms is given by patients if they presented with a symptom and the symptom disappeared after the next drug dose. Two positive answers are diagnostic of wearing-off (WO). A negative change score indicates improvement.

    Measured: Baseline to end of study (Month 3)

Timeline

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

  1. First posted25 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2008
  4. Study completionJun 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391898
Sponsor's protocol ID
CELC200AES03
Status last verified
Feb 2011
First submitted
24 Oct 2006
Last updated
15 Mar 2011

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levodopa/carbidopa/entacapone and Levodopa/carbidopa in people with Parkinson's Disease, run by Novartis at 26 sites in Spain.

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 11 inclusion and 14 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 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain. 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 15 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?

Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3 (time frame: Baseline to end of study (Month 3)). 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 NCT00391898.

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 15 Mar 2011.

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