Parkinson DiseasePhase 3HoneymoonNCT02786667
Non Motors Aspects in De Novo Parkinson's Disease
A Phase 3 study testing Rotigotine in people with Parkinson Disease and Apathy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease. Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study. Read more about this study
- Who is it for?
- Ages 30 to 72 years
- Conditions the study is for
- Parkinson Disease, Apathy
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Dec 2017
- 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 30 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson disease without treatment for Parkinson disease
- Recent diagnosis (< 2 years)
- Without cognitive troubles
Who cannot join
- Patients with cognitive troubles
- Treated patients with L-Dopa or Dopamine agonists
- Other severe illness
- Pregnant or parturient woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.
Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.
Read the detailed description
This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease.
The study consists of three parts:
- The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome.
- From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET).
- In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study.
We hypothesize a significant improvement of apathy in the rotigotine group versus placebo
- Conditions
- Parkinson Disease, Apathy
- Being tested
- Rotigotine, Placebo
- 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.
RotigotineDrug
Also called Neupro
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
PlaceboDrug
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | 6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month Receives: Drug: Rotigotine |
| Placebo | Placebo comparator | 6 months treatment with Placebo up to 8 mg per day with a titration period for one month Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
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 posted1 Jun 2016 (estimated)
- Study startJun 2012
- Primary completion15 Oct 2017
- Study completionDec 2017 (estimated)
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 199 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
- NCT02786667
- Sponsor's protocol ID
- 2011-002855-33
- Acronym
- Honeymoon
- Status last verified
- Oct 2017
- First submitted
- 18 May 2016
- Last updated
- 26 Oct 2017
- 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 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
- ClinicalTrials.gov ID
- NCT02786667
- Acronym / sponsor ID
- Honeymoon / 2011-002855-33
- Conditions
- Parkinson Disease, Apathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Jun 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.
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.
Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.
Detailed description
This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease.
The study consists of three parts:
- The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome.
- From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET).
- In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study.
We hypothesize a significant improvement of apathy in the rotigotine group versus placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: Rotigotine6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month |
| Placebo | Placebo comparator | Drug: Placebo6 months treatment with Placebo up to 8 mg per day with a titration period for one month |
Who may qualify
- Ages
- 30 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson disease without treatment for Parkinson disease
- Recent diagnosis (< 2 years)
- Without cognitive troubles
Key exclusion criteria (4 listed)
- Patients with cognitive troubles
- Treated patients with L-Dopa or Dopamine agonists
- Other severe illness
- Pregnant or parturient woman
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 |
|---|---|---|
| RotigotineAlso: Neupro6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month | Drug | Rotigotine |
| Placebo6 months treatment with Placebo up to 8 mg per day with a titration period for one month | Drug | Placebo |
Primary outcome
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- 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
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 Rotigotine in people with Parkinson Disease and Apathy, run by University Hospital, Grenoble 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 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
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?
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group (time frame: 6 months). 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 26 Oct 2017.