Drug-naïve Patients With Parkinson's DiseasePhase 4NCT01765257
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
A Phase 4 study testing AZILECT® in people with Drug-naïve Patients With Parkinson's Disease and Apathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Drug-naïve Patients With Parkinson's Disease, Apathy
- What is being tested?
- AZILECT®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Mar 2015
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
- No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26)
- No depression (MADRS < 15)
- Criteria of apathy from Robert et al (2009)
- At least mild apathy (≥-21 to Lille Apathy Rating Scale)
- Age : 35-70 y
- Affiliation to social security
- Agreement of patients
Who cannot join
- - Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
- Ongoing severe psychiatric or somatic diseases
- Others treatments :
- antipsychotics
- antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
- psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)
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- any contra-indication according to SmPC
- patients under guardianship
- Women without efficient contraception
- Person who participate to an other study
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.
Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease.
The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
Read the detailed description
Study design :
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
Population :
50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.
3 visits
- Visit 1 : inclusion / randomisation/ first study medication dispensation
- Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
- Visit 3 (3 months after V1, final visit) : second evaluation
- Being tested
- AZILECT®, Placebo
- Keywords
- Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline
- Medical subject headings
- Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZILECT®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| rasagiline | Experimental | Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France Receives: Drug: AZILECT® |
| placebo | Placebo comparator | Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lille Apathy Rating Scale (LARS) score
Measured: at the visit 3 (after 3 months of treatment)
Secondary outcomes (7)
Motor assessment : Unified Parkinson's Disease Rating Scale
Measured: at the visit 3 (after 3 months of treatment)
Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale
Measured: at the visit 3 (after 3 months of treatment)
Self assessment of apathy : Starkstein
Measured: at the visit 3 (after 3 months of treatment)
Quality of life : PDQ 39
Measured: at the visit 3 (after 3 months of treatment)
Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery
Measured: at the visit 3 (after 3 months of treatment)
Hyperdopaminergic symptoms : Parkinson's disease behavioral scale
Measured: at the visit 3 (after 3 months of treatment)
Fatigue assessment : Parkinson Fatigue Scale
Measured: at the visit 3 (after 3 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-naïve Patients With Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S, CHU Purpan (Toulouse), Hôpital Haut-Lévêque, Centre Hospitalier de la côte Basque, Poitiers University Hospital, Rennes University Hospital, University Hospital, Lille, Hôpital Dupuytren, University Hospital, Caen, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier du Pays d'Aix, Hôpital de la Timone (MARSEILLE), University Hospital, Rouen, Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire de Saint Etienne, Fondation Rothschild Paris
- Responsible party
- Sponsor
- Investigators
- Denis PEZET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765257
- Sponsor's protocol ID
- CHU-0138
- Other IDs
- 2007-002800-16
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 10 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.
- ClinicalTrials.gov ID
- NCT01765257
- Acronym / sponsor ID
- CHU-0138
- Keywords
- Drug-naïve patients with Parkinson's disease, Apathy, Rasagiline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S, CHU Purpan (Toulouse), Hôpital Haut-Lévêque, Centre Hospitalier de la côte Basque, Poitiers University Hospital, Rennes University Hospital, University Hospital, Lille, Hôpital Dupuytren, University Hospital, Caen, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier du Pays d'Aix, Hôpital de la Timone (MARSEILLE), University Hospital, Rouen, Centre Hospitalier Universitaire, Amiens, Centre Hospitalier Universitaire de Saint Etienne, Fondation Rothschild Paris
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 10 Jan 2013 (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.
Among the psychiatric symptoms observed in the premotor phase of Parkinson's disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.
Rasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson's disease.
The primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson's disease, using a treatment by rasagiline.
Detailed description
Study design :
Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France
Population :
50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.
3 visits
- Visit 1 : inclusion / randomisation/ first study medication dispensation
- Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.
- Visit 3 (3 months after V1, final visit) : second evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rasagiline | Experimental | Drug: AZILECT®Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France |
| placebo | Placebo comparator | Drug: PlaceboRandomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)
- No dementia (Mattis dementia rating scale > 130; Mini Mental Sate Examination ≥26)
- No depression (MADRS < 15)
- Criteria of apathy from Robert et al (2009)
- At least mild apathy (≥-21 to Lille Apathy Rating Scale)
Key exclusion criteria (10 listed)
- - Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.
- Ongoing severe psychiatric or somatic diseases
- Others treatments :
- antipsychotics
- antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)
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 |
|---|---|---|
| AZILECT® | Drug | rasagiline |
| Placebo | Drug | placebo |
Primary outcome
Lille Apathy Rating Scale (LARS) score
Time frame: at the visit 3 (after 3 months of treatment)
7 secondary outcomes
Motor assessment : Unified Parkinson's Disease Rating Scale
Time frame: at the visit 3 (after 3 months of treatment)
Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale
Time frame: at the visit 3 (after 3 months of treatment)
Self assessment of apathy : Starkstein
Time frame: at the visit 3 (after 3 months of treatment)
Quality of life : PDQ 39
Time frame: at the visit 3 (after 3 months of treatment)
Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery
Time frame: at the visit 3 (after 3 months of treatment)
Hyperdopaminergic symptoms : Parkinson's disease behavioral scale
Time frame: at the visit 3 (after 3 months of treatment)
Fatigue assessment : Parkinson Fatigue Scale
Time frame: at the visit 3 (after 3 months of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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.
Denis PEZET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AZILECT® in people with Drug-naïve Patients With Parkinson's Disease and Apathy, run by University Hospital, Clermont-Ferrand 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 8 inclusion and 10 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 10 Jan 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lille Apathy Rating Scale (LARS) score (time frame: at the visit 3 (after 3 months of treatment)). 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 10 Jan 2013.