AddictionPROBA-PDNCT02671240
Prognosis of Behavioral Addiction in Parkinson's Disease
An observational study of Addiction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Addiction
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2016to 19 Apr 2019
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease who developed or not a behavioral addiction
Who may be able to join
- Age greater than or equal to 30 years
- Parkinson's disease according to the criteria of UKPDSBB
- Time evolution of the top disease or equal to 5 years
Who cannot join
- Lack of Parkinson's disease and atypical parkinsonism
- Patient not previously included in PD-BADGE
Trial locations and contacts
1 site in 1 country.
About this study
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.
Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.
- Conditions
- Addiction
- Keywords
- Parkinson disease, behavioral addiction, akinéto-rigid syndrome, dopamine agonist
- Medical subject headings
- Behavior, Addictive, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| - Patients with behavioral addiction | Not described | |
| - Patients with no behavioral addiction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease
Measured: 12 months after selection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start24 Oct 2016
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Why it stopped: Investigator's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu ANHEIM, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671240
- Sponsor's protocol ID
- 6246
- Acronym
- PROBA-PD
- Status last verified
- Aug 2023
- First submitted
- 18 Jan 2016
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Behavioral Addiction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02671240
- Acronym / sponsor ID
- PROBA-PD / 6246
- Conditions
- Addiction
- Keywords
- Parkinson disease, behavioral addiction, akinéto-rigid syndrome, dopamine agonist
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator's decision
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 2 Feb 2016 (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.
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.
Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| - Patients with behavioral addiction | – | – |
| - Patients with no behavioral addiction | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease who developed or not a behavioral addiction
Key inclusion criteria (3 listed)
- Age greater than or equal to 30 years
- Parkinson's disease according to the criteria of UKPDSBB
- Time evolution of the top disease or equal to 5 years
Key exclusion criteria (2 listed)
- Lack of Parkinson's disease and atypical parkinsonism
- Patient not previously included in PD-BADGE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease
Time frame: 12 months after selection
Results and safety
The study was stopped early (reason given: Investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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.
Mathieu ANHEIM, MD, PhD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by University Hospital, Strasbourg, France 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 3 inclusion and 2 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 23 Aug 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.
Are results available for this study?
The study was stopped early (reason given: Investigator's decision). Results are not available in the source record.
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?
Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease (time frame: 12 months after selection). 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 23 Aug 2023.