Parkinson DiseaseIMPACTNCT03141944
Evolution of Hypodopaminergic Syndrome in Early Parkinson's Disease
An observational study of Parkinson Disease and Apathy, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 33 to 72 years
- Conditions the study is for
- Parkinson Disease, Apathy
- What is being tested?
- Starkstein scale of Apathy
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Feb 2017to 11 Mar 2020
- Phase
- Observational
- 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 33 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinon's disease who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667 between june 2012 and june 2016
Who may be able to join
- patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
- Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
- Patients with medical insurance
- signed informed consent
Who cannot join
- diagnosis other than Parkinson's Disease
- dementia (Mattis <130)
- patients protected by law (i.e. pregnant or parturient women)
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital of Grenoble
Grenoble, 38043
Hôpital Neurologique Pierre Wertheimer
Lyon
Centre Expert Régional pour la maladie de Parkinson
Poitiers
Hôpital de Hautepierre
Strasbourg
About this study
Official title: Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease
The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.
Read the detailed description
All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.
3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.
The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.
Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.
- Conditions
- Parkinson Disease, Apathy
- Being tested
- Starkstein scale of Apathy
- Keywords
- non motor symptoms
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starkstein scale of ApathyOther
The degree of apathy will be evaluated with the "Starkstein scale of Apathy"
| Study group | Role | What they receive |
|---|---|---|
| Apathetic patients | De novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion.
All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy" Receives: Other: Starkstein scale of Apathy | |
| Non-apathetic patients | De novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion.
All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy" Receives: Other: Starkstein scale of Apathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of apathy in Parkinson's disease
Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".
Measured: 1day
Secondary outcomes (8)
Evolution of hypodopaminergia in Parkinson's disease
Evolution of hypodopaminergic symptoms in Patients with Parkinson's disease under dopaminergic treatment. Hypodopaminergic symptoms are evaluated with different scales: ECMP (behavioral evaluation in Parkinsons's disease) for depression and anxiety, STAI (State-trait-anxiety inventory, self-assessment-questionnaire for anxiety, BDI (Beck depression inventory) for depression, PFS-16 (Piper Fatigue Sale) for fatigue. Hypodopaminergia is the expressed as the sum of its symptoms.
Measured: 1 day
Apparition of hyperdopaminergic symptoms in Parkinson's disease
Apparition of hyperdopaminergic symptoms in patients with Parkinson's disease under dopaminergic treatment, with the questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP) and the ECMP scale.
Measured: 1 day
Evolution of impulsivity in Parkinson's disease
Evolution of impulsivity in patients with Parkinson's disease under dopaminergic treatment. Evaluation with a self-assessment-questionnaire (UPPS Impulsive Behavior Scale)
Measured: 1 day
Evolution of personality in Parkinson's disease
Evolution of personality in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire "Temperament and Character Inventory" (TCI).
Measured: 1 day
Evolution of pain in Parkinson's disease
Evolution of pain in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire NPSI (Neuropathic Pain Symptom Inventory).
Measured: 1 day
Evolution of quality of life in Parkinson's disease
Evolution of quality of life in patients with Parkinson's disease under dopaminergic treatment with the self-assessment-questionnaire PDQ39 (Parkinson's disease questionnaire).
Measured: 1 day
Evolution of somnolence in Parkinson's disease
Evolution of somnolence in patients with Parkinson's disease under dopaminergic treatment with the ECMP scale.
Measured: 1 day
Evolution of eating behavior in Parkinson's disease
Evolution of eating behavior in patients with Parkinson's disease under dopaminergic treatment with the self-assesment-questionnaire "Dutch Eating Behavior Questionnaire" - DEBQ.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start23 Feb 2017
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna CASTRIOTO, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141944
- Sponsor's protocol ID
- 38RC16.184
- Acronym
- IMPACT
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2017
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03141944
- Acronym / sponsor ID
- IMPACT / 38RC16.184
- Conditions
- Parkinson Disease, Apathy
- Keywords
- non motor symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 5 May 2017 (actual)
- 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 objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.
Detailed description
All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.
3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.
The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.
Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apathetic patients | – | Other: Starkstein scale of ApathyDe novo Parkinson's Disease patients with Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy" |
| Non-apathetic patients | – | Other: Starkstein scale of ApathyDe novo Parkinson's Disease patients without Apathy which participated in a former study and are under dopaminergic treatment at inclusion. All patients will be evaluated with regard to apathy, depression, pain, behavior and personality. Primary outcome measure is the degree of Apathy by the "Starkstein scale of apathy" |
Who may qualify
- Ages
- 33 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinon's disease who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667 between june 2012 and june 2016
Key inclusion criteria (4 listed)
- patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
- Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
- Patients with medical insurance
- signed informed consent
Key exclusion criteria (3 listed)
- diagnosis other than Parkinson's Disease
- dementia (Mattis <130)
- patients protected by law (i.e. pregnant or parturient women)
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 |
|---|---|---|
| Starkstein scale of ApathyThe degree of apathy will be evaluated with the "Starkstein scale of Apathy" | Other | Apathetic patients, Non-apathetic patients |
Primary outcome
Evolution of apathy in Parkinson's disease
Time frame: 1day
Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".
8 secondary outcomes
Evolution of hypodopaminergia in Parkinson's disease
Time frame: 1 day
Apparition of hyperdopaminergic symptoms in Parkinson's disease
Time frame: 1 day
Evolution of impulsivity in Parkinson's disease
Time frame: 1 day
Evolution of personality in Parkinson's disease
Time frame: 1 day
Evolution of pain in Parkinson's disease
Time frame: 1 day
Evolution of quality of life in Parkinson's disease
Time frame: 1 day
Evolution of somnolence in Parkinson's disease
Time frame: 1 day
Evolution of eating behavior in Parkinson's disease
Time frame: 1 day
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 29 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Anna CASTRIOTO, MD principal investigator
University Hospital, Grenoble
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Apathy, run by University Hospital, Grenoble at 4 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 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Evolution of apathy in Parkinson's disease (time frame: 1day). It is what the study was designed to measure, not a finding.
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 29 Mar 2021.