Parkinson DiseaseEFN-VALIDNCT04455074
Validation of the Neuropsychiatric Fluctuations Scale (EFN-VALID))
A study testing FN scale auto-questionnaire in people with Parkinson Disease and Fluctuating Mood Symptoms, run by University Hospital, Grenoble at 6 sites in France.
Trial summary
Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson Disease, Fluctuating Mood Symptoms
- What is being tested?
- FN scale auto-questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Sep 2020to 23 Mar 2023
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
- presence of motor fluctuations, requiring a levodopa test
- french native speaker
Who cannot join
- Dementia (MoCa < 24)
- Parkinson syndrome other than idiopathic PD
- people excluded according to french law (including pregnant women or nursing mothers, ...)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Amiens
Amiens, 80 054
CHU de Bordeaux-Hôpital Pellegrin
Bordeaux, 33 076
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
University hospital grenoble
Grenoble, 38043
Hospices Civils Lyon (HCL)
Lyon, 69 677
CHRU Strasbourg
Strasbourg, 67091
About this study
Official title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.
Read the detailed description
Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. Early diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. The NFS is composed of 20 items among which ten measure the "ON neuropsychological state" and ten, the "OFF neuropsychological state". It provides two sub-scores (one ON and one OFF) with a maximal total score of 30.
- Conditions
- Parkinson Disease, Fluctuating Mood Symptoms
- Being tested
- FN scale auto-questionnaire
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FN scale auto-questionnaireOther
Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.
| Study group | Role | What they receive |
|---|---|---|
| PD patients with motor fluctuations | Experimental | FN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition Receives: Other: FN scale auto-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of FN scale: realiability
EFN score
Measured: 2 months
validation of FN scale: internal consistency
EFN score
Measured: 4 hours
validation of FN scale: measurement error
test-retest
Measured: 2 months
validation of FN scale: structural validity
EFN score
Measured: 4 hours
validation of FN scale: responsiveness
Measured: 4 hours
validation of FN scale: acceptability
EFN score
Measured: 4 hours
Secondary outcomes (9)
correlation of EFN scores with socio-clinical characteristics 1
MDS-UPDRS
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics 2
Severity of PD (Clinical Impression of Severity Index for PD - CISI-PD)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics 3
stage of PD (Hoehn \& Yahr stage)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (4)
cognitif state (Montreal cognitive assessment - MoCA test)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (5)
Impulsive-Compulsive Disorders (QUIP-RS)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (6)
Dopamine-dependant behavior (ACDD)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (7)
Wearing off (QUICK questionnaire)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (8)
Depression (Beck depression inventory BDI-II)
Measured: 4 hours
correlation of EFN scores with socio-clinical characteristics (9)
Evalulation of impulsive behavior (UPSS)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start23 Sep 2020
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
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 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Elena MORO, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455074
- Sponsor's protocol ID
- 38RC20.116
- Other IDs
- 2020-A00862-37
- Acronym
- EFN-VALID
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmitt E, Bouvard M, Anheim M, Guehl D, Klinger H, Laurencin C, Marques A, Meissner WG, Thobois S, Thomas J, Tir M, Debu B, Moro E; NFS-VALID Study. Neuropsychiatric fluctuations in Parkinson's disease: A French multicenter study of the NFS psychometric properties. Parkinsonism Relat Disord. 2025 Sep;138:107954. doi: 10.1016/j.parkreldis.2025.107954. Epub 2025 Jul 11.
PubMed 40683099
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
- ClinicalTrials.gov ID
- NCT04455074
- Acronym / sponsor ID
- EFN-VALID / 38RC20.116
- Conditions
- Parkinson Disease, Fluctuating Mood Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 2 Jul 2020 (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.
Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.
Detailed description
Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. Early diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. The NFS is composed of 20 items among which ten measure the "ON neuropsychological state" and ten, the "OFF neuropsychological state". It provides two sub-scores (one ON and one OFF) with a maximal total score of 30.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients with motor fluctuations | Experimental | Other: FN scale auto-questionnaireFN scale is an autoquestionnaire consisting of 20 questions, to be answered in On-med and OFF-med condition |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Parkinson's disease
- presence of motor fluctuations, requiring a levodopa test
- french native speaker
Key exclusion criteria (3 listed)
- Dementia (MoCa < 24)
- Parkinson syndrome other than idiopathic PD
- people excluded according to french law (including pregnant women or nursing mothers, ...)
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 |
|---|---|---|
| FN scale auto-questionnairePatients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med. | Other | PD patients with motor fluctuations |
Primary outcome
validation of FN scale: realiability
Time frame: 2 months
EFN score
validation of FN scale: internal consistency
Time frame: 4 hours
EFN score
validation of FN scale: measurement error
Time frame: 2 months
test-retest
validation of FN scale: structural validity
Time frame: 4 hours
EFN score
validation of FN scale: responsiveness
Time frame: 4 hours
validation of FN scale: acceptability
Time frame: 4 hours
EFN score
9 secondary outcomes
correlation of EFN scores with socio-clinical characteristics 1
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics 2
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics 3
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (4)
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (5)
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (6)
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (7)
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (8)
Time frame: 4 hours
correlation of EFN scores with socio-clinical characteristics (9)
Time frame: 4 hours
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 22 Dec 2025.
- Results publication: PubMed 40683099Schmitt E, Bouvard M, Anheim M, Guehl D, Klinger H, Laurencin C, Marques A, Meissner WG, Thobois S, Thomas J, Tir M, Debu B, Moro E; NFS-VALID Study. Neuropsychiatric fluctuations in Parkinson's disease: A French multicenter study of the NFS psychometric properties. Parkinsonism Relat Disord. 2025 Sep;138:107954. doi: 10.1016/j.parkreldis.2025.107954. Epub 2025 Jul 11.
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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.
Elena MORO, MD PhD principal investigator
University Hospital, Grenoble
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FN scale auto-questionnaire in people with Parkinson Disease and Fluctuating Mood Symptoms, run by University Hospital, Grenoble at 6 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 3 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
validation of FN scale: realiability (time frame: 2 months). The study lists 6 primary outcomes in all. 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 NCT04455074, 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 22 Dec 2025.