Parkinson's DiseasePhase 2NCT01291537
Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
A Phase 2 study testing Duodopa and best médical treatment in people with Parkinson's Disease, run by Poitiers University Hospital at 20 sites in France.
Trial summary
The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Duodopa and best médical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 20 sitesFrance
- Study dates
- Nov 2011to Mar 2016
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years and ≤ 80 years
- Akineto-hypertonic and/or tremor forms of Parkinson's disease as defined by the criteria of the French National Consensus conference for Parkinson's disease (March 2000)
- Absence of parkinsonism other than a Parkinson's disease, including absence of one or more of the following signs: autonomic syndrome, hallucinations, pyramidal signs, early postural instability, early cognitive impairment (including apraxia or severe frontal lobe syndrome) (Consensus Conference, March 2000)
- Severe and advanced forms of Parkinson's disease with sensitivity to L-dopa (≥ 40%)
- No contraindication to Duodopa®: hypersensitivity to levodopa and carbidopa, or any of the excipients, angle-closure glaucoma, kidney and liver failures, severe heart failure, severe cardiac arrhythmia, acute stroke, pheochromocytoma, hyperthyroidism, Cushing syndrome, association with non-selective MAOIs and selective MAOIs-A (stop at least 2 weeks before initiation of Duodopa®)
- Fluctuations in motor performance (with OFF time ≥ 2 hours per day) and/or dyskinesia induced by L-DOPA altering significantly the activities of daily life in spite of an optimized treatment
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- Hoehn and Yahr score < 4 in best ON
- Ability to complete a diary of self-evaluation (with the help of another person if necessary)
- MMSE ≥ 24/30
- No evolutive psychosis or history of severe psychosis requiring hospitalization
- No digestive disease or ENT evolutionary
- No concomitant treatment by continuous infusion of apomorphine
- No concomitant treatment by deep brain stimulation
- No serious somatic disease likely to interfere with a good participation to the study, contraindication for gastrostomy
- Menopause proven or woman of childbearing potential with an effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgery: ligation of the fallopian tubes, hysterectomy, total ovariectomy)
Who cannot join
- Age <18 and> 80 years
- No signature of the informed consent form
- Patient with no social insurance or who cannot benefit it through a third person in accordance with the French law on biomedical research
- Population under enhanced protection (i.e minors), pregnant women, breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, people in health and social service, adults under legal protection, and finally patients in emergency situations.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CH d'Aix en Provence
Aix-en-Provence, 13616
Chu Amiens
Amiens
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Hôpital Henri Mondor
Créteil, 94010
Chu Lille
Lille, 59037
Chu de Limoges
Limoges, 87000
Chu de Lyon
Lyon, 69229
Chu de Marseille
Marseille, 13354
Chu de Nantes
Nantes, 44035
Chu de Nice
Nice, 06003
Chu de Nimes
Nîmes, 30029
Ch Saint Antoine
Paris, 75571
Ch La Pitie Salpetriere
Paris, 75651
Chu de Poitiers
Poitiers, 86021
Chu de Rennes
Rennes, 35033
Chu de Rouen
Rouen, 76031
Chu Saint Etienne
Saint-Etienne, 42055
Chu de Strasbourg
Strasbourg, 67091
Chu Bordeaux
Talence, 33404
Chu de Toulouse
Toulouse, 31059
About this study
The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.
- Conditions
- Parkinson's Disease
- Being tested
- Duodopa, best médical treatment
- Keywords
- Advanced, Severe form
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuodopaDrug
best médical treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Duodopa | Experimental | Not described Receives: Drug: Duodopa |
| Best medical treatment | Active comparator | Not described Receives: Drug: best médical treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291537
- Sponsor's protocol ID
- CECILE 2010-020769-25
- Status last verified
- Oct 2016
- First submitted
- 7 Feb 2011
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT01291537
- Acronym / sponsor ID
- CECILE 2010-020769-25
- Conditions
- Parkinson's Disease
- Keywords
- Advanced, Severe form
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2016 (actual)
- First posted
- 8 Feb 2011 (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 goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodopa | Experimental | Drug: Duodopa |
| Best medical treatment | Active comparator | Drug: best médical treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age> 18 years and ≤ 80 years
- Akineto-hypertonic and/or tremor forms of Parkinson's disease as defined by the criteria of the French National Consensus conference for Parkinson's disease (March 2000)
- Absence of parkinsonism other than a Parkinson's disease, including absence of one or more of the following signs: autonomic syndrome, hallucinations, pyramidal signs, early postural instability, early cognitive impairment (including apraxia or severe frontal lobe syndrome) (Consensus Conference, March 2000)
- Severe and advanced forms of Parkinson's disease with sensitivity to L-dopa (≥ 40%)
- No contraindication to Duodopa®: hypersensitivity to levodopa and carbidopa, or any of the excipients, angle-closure glaucoma, kidney and liver failures, severe heart failure, severe cardiac arrhythmia, acute stroke, pheochromocytoma, hyperthyroidism, Cushing syndrome, association with non-selective MAOIs and selective MAOIs-A (stop at least 2 weeks before initiation of Duodopa®)
Key exclusion criteria (4 listed)
- Age <18 and> 80 years
- No signature of the informed consent form
- Patient with no social insurance or who cannot benefit it through a third person in accordance with the French law on biomedical research
- Population under enhanced protection (i.e minors), pregnant women, breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, people in health and social service, adults under legal protection, and finally patients in emergency situations.
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 |
|---|---|---|
| Duodopa | Drug | Duodopa |
| best médical treatment | Drug | Best medical treatment |
Primary outcome
Not reported in the source record.
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 11 Oct 2016.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duodopa and best médical treatment in people with Parkinson's Disease, run by Poitiers University Hospital at 20 sites in France.
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 15 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 11 Oct 2016.