Parkinsons's DiseasePhase 3APO-TEPNCT01039090
Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's Disease
A Phase 3 study testing Continuous Apomorphine infusion and Usual dopaminergic per os treatment in people with Parkinsons's Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinsons's Disease
- What is being tested?
- Continuous Apomorphine infusion and Usual dopaminergic per os treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Feb 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and more
- Parkinson's disease according to UKPDSBB diagnosis criteria
- Motor difficulties in spite of dopaminergic per os treatment
- Not eligible for deep brain stimulation for one or more reasons (age>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations)
Who cannot join
- Mattis scale < 120
- Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment)
- Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study
In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.
Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.
- Conditions
- Parkinsons's Disease
- Being tested
- Continuous Apomorphine infusion, Usual dopaminergic per os treatment
- Keywords
- Not eligible for deep brain stimulation, Parkinsons's patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Apomorphine infusionDrug
Continuous Apomorphine infusion during 6 months
Usual dopaminergic per os treatmentDrug
No specific change in the dopaminergic per os treatment
| Study group | Role | What they receive |
|---|---|---|
| Per os dopaminergic treatment | Active comparator | Not described Receives: Drug: Usual dopaminergic per os treatment |
| Continuous Apomorphine infusion | Experimental | Not described Receives: Drug: Continuous Apomorphine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2014
- Study completionFeb 2015
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 Parkinsons's DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VERIN, MD PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039090
- Sponsor's protocol ID
- 2008-006045-10
- Other IDs
- LOC/08-08, 2008
- Acronym
- APO-TEP
- Status last verified
- May 2023
- First submitted
- 22 Dec 2009
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.
PubMed 28017228
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study
- ClinicalTrials.gov ID
- NCT01039090
- Acronym / sponsor ID
- APO-TEP / 2008-006045-10
- Conditions
- Parkinsons's Disease
- Keywords
- Not eligible for deep brain stimulation, Parkinsons's patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2009 (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.
In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.
Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Per os dopaminergic treatment | Active comparator | Drug: Usual dopaminergic per os treatment |
| Continuous Apomorphine infusion | Experimental | Drug: Continuous Apomorphine infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and more
- Parkinson's disease according to UKPDSBB diagnosis criteria
- Motor difficulties in spite of dopaminergic per os treatment
- Not eligible for deep brain stimulation for one or more reasons (age>70, axial troubles in spite of dopaminergic per os treatment, cognitive troubles and/or hallucinations)
Key exclusion criteria (3 listed)
- Mattis scale < 120
- Contraindication to Apomorphine (liver insufficiency, severe cognitive troubles, allergy, pregnancy, neuroleptic treatment)
- Contraindication to Fluoro-Deoxy-Glucose which is used in PET-Scan (allergy, kidney failure, pregnancy, breast feeding)
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 |
|---|---|---|
| Continuous Apomorphine infusionContinuous Apomorphine infusion during 6 months | Drug | Continuous Apomorphine infusion |
| Usual dopaminergic per os treatmentNo specific change in the dopaminergic per os treatment | Drug | Per os dopaminergic treatment |
Primary outcome
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger
Time frame: 6 months
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 24 May 2023.
- Results publication: PubMed 28017228Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.
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.
Marc VERIN, MD PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous Apomorphine infusion and Usual dopaminergic per os treatment in people with Parkinsons's Disease, run by Rennes University Hospital at 1 site 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 4 inclusion and 3 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Neuropsychological results: Montgomery-Åsberg Depression Rating Scale (MADRS), The Lille Apathy Rating Scale (LARS), Spielberger (time frame: 6 months). 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 NCT01039090, 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 24 May 2023.