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Parkinson DiseaseAGAPONCT03693872

Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

A study testing Apomorphine and Dopaminergic Agonist + Apomorphine in people with Parkinson Disease, run by Rennes University Hospital at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Apomorphine and Dopaminergic Agonist + Apomorphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
6 sitesFrance
Study dates
15 May 2019to 2 Jun 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged = or > 18 years,
  • Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of symptoms,
  • Indicated for apomorphine pump therapy and according to the centers' practice, treatment with apomorphine pump association with dopamine agonists or apomorphine pump therapy alone
  • Presence of fluctuations for > 3 years,
  • Patients covered with social insurance.
  • Written informed consent

Who cannot join

  • Neurological (other than Parkinson's disease) or severe psychiatric history (depression, schizophrenia, addiction, bipolar disorder, anxiety and depressive disorders);
  • Severe neurocognitive disorders (DSM-V)
  • History of use of apomorphine pump treatment or deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa;
  • History or current drug or alcohol abuse or dependencies;
  • History of impulse control disorders;
  • Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty;
  • Inability to understand the information given on the study, to express informed consent.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites
  • Hôpital Gui de Chauliac

    Montpellier, 34295

  • CH Caremeau

    Nîmes, 30029

  • CHU La Pitié Salpêtrière

    Paris, 75013

  • CHU de Reims- hôpital Maison Blanche

    Reims, 51100

  • CHU de Rennes

    Rennes, 35033

  • CHU Charles Nicolle

    Rouen, 76000

Other trials in France

About this study

There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. To date, there has been no study led to determine the best strategy for efficiently treating motor and nonmotor symptoms, as well as improving patients' quality of life (QoL). This preliminary study, entitled AGAPO, aims at identifying significant differences in patients' evolution (nonmotor symptoms and quality of life), over a course of 6 months, depending on the two strategies adopted in French centers (apomorphine pump with or without dopaminergic agonists), through the Non Motor Symptoms Scale (NMSS, Chaudhuri et al, 2017).

Read the detailed description

The recruitment period will be 24 months. The duration of the study will be 6 months for each patient due to adjustments of apomorphine pump parameters and oral medication as well time needed for motor and nonmotor changes to develop and influence QoL.

This study will be done without any modification of the planned treatment plan for each patient included. The treatments are administered in accordance with their marketing authorization and according to the usual practices of each center. No additional visits are expected.

Being tested
Apomorphine, Dopaminergic Agonist + Apomorphine
Keywords
Parkinson, Nonmotor symptomatology
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApomorphineDrug

    Also called APO

    Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient

  • Dopaminergic Agonist + ApomorphineDrug

    Also called AGAPO

    Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient and associated with dopaminergic agonists

Study groups in NCT03693872
Study groupRoleWhat they receive
ApomorphineOtherWithdrawal of dopaminergic agonists at pump initiation
Receives: Drug: Apomorphine
Dopaminergic Agonist + ApomorphineOtherContinuation of dopaminergic agonists at pump initiation
Receives: Drug: Dopaminergic Agonist + Apomorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up

    The Non-Motor Symptoms Scale (NMSS) measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease, through 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe). Frequency is rated on a scale from 1 (rarely) to 4 (very frequent). Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms (reduced score).

    Measured: 6 months

Secondary outcomes (17)
  1. Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up

    Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life.

    Measured: 6 months

  2. Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up

    The Change in the Neurologist (clinician) Global Impression of change (CGI) provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. It ranges from severely impaired to dramatically improved.

    Measured: 6 months

  3. Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6 months' follow up

    The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part I include 13 items (6 semistructured interview items and 7 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.

    Measured: 6 months

  4. Change in apathy assessed on the long version of Lille Apathy Rating Scale between the Baseline assessment and the assessment at 6 months' follow up (LARS)

    The Lille apathy rating scale (LARS) is a measure of apathy through nine domains (each corresponding to a clinical manifestation of apathy: everyday productivity, interests, taking the initiative, novelty seeking, motivation - Voluntary actions, emotional responses, concern, social life \& self-awareness) and 33 queries. The interview is structured, with a precise scoring mode for each reply (-2 to 2); when an item does not apply to the patient or the reply cannot be classified, it is scored "0" (for non-applicable and/or non-classifiable) The scale's overall score ranges from -36 to +36, with highest scores reflecting apathy severity. 4 factorial sub-scores (intellectual curiosity, emotion, action initiation and self-awareness) are calculated from sub-scale scores.

    Measured: 6 months

  5. Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up

    Present feelings

    Measured: 6 months

  6. Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up

    General feelings

    Measured: 6 months

  7. Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up

    Changes from baseline in hyper and hypo dopaminergic symptoms scores will be assessed through the Ardouin Scale of Behavior in Parkinson's Disease (ASBPD). It is designed for assessing mood and behavior with a view to quantifying changes related to Parkinson's disease, to dopaminergic medication, and to non-motor fluctuations. Its 21 items address nonmotor symptoms and are grouped into four dimensions: general psychological assessment, apathy, nonmotor fluctuations and hyperdopaminergic behaviors, with a 5-point rating scale ranging from 0 (Absent) to 4 (Severe). A score ≥ 2 is considered as a warning sign.

    Measured: 6 months

  8. Change in emotional function assessed by the short form of the TEIQue between the Baseline assessment and the assessment at 6 months' follow upscale

    The Trait Emotional Intelligence Questionnaire-Short Form (TEIQue-SF) aims at evaluating emotional intelligence through a self-report inventory that measure global trait emotional intelligence (trait EI) through a 30-item questionnaire. The trait EI is about perceptions and not about abilities, competencies or skills ; high scores are not necessarily adaptive (good) and low scores are not necessarily maladaptive (bad).

    Measured: 6 months

  9. Change in emotional function assessed by the short form of the BEQ scale between the Baseline assessment and the assessment at 6 months' follow up

    The Berkeley Expressivity Questionnaire (BEQ) is a self-report measure of three emotional expressivity facets related to emotional expressivity: expressivity of negative and positive emotions, and strength of expression impulse. Each of the 16 items is answered on a 7-point Likert-type ranging from 1 (strongly disagree) to 7 (strongly agree). The 3 facets can be kept as separate scores or combined to form an overall Emotional Expressivity score.

    Measured: 6 months

  10. Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the Baseline assessment and the assessment at 6 months' follow up

    The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part II include 13 self-reported items) scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.

    Measured: 6 months

  11. Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6 months' follow up

    The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part III include 18 items scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.

    Measured: 6 months

  12. Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6 months' follow up

    The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the standard validated tool for the assessment of patients with Parkinson's Disease (PD). This combined scale includes subsections collecting data regarding: nonmotor experiences of daily living (part I), their motor experiences of daily living (part II) an examination of the motor features of PD (part III), and motor complications arising from the use of dopamine replacement (part IV). The Part IV include 6 items assessed in a semistructured interview, scored on a scale from 0 (normal) to 4 (severe). Higher scores reflect worse condition.

    Measured: 6 months

  13. Change in motor examination with the Schwab and England scale between the Baseline assessment and the assessment at 6 months' follow up

    The Schwab \& England activities of daily living evaluates patients' autonomy through a percentage ranging from 0% (=Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden.) to 100% ( = Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal).

    Unaware of any difficulty.

    Measured: 6 months

  14. Change in motor examination with the Hoehn & Yarr scale

    The severity of PD is assessed through the Modified Hoehn \& Yahr rating scale, consisting of 10levels comprised between 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).

    Measured: 6 months

  15. Change in cognitive function assessed by the MoCA scale between the Baseline assessment and the assessment at 6 months' follow up

    The Montreal Cognitive Assessment (MoCA) is a short tool (one-page 30-point test administered in approximately 10 minutes) to evaluate a multitude of cognitive domains (visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation). MoCA scores range between 0 and 30; a score ≥ 26 is considered to be normal.

    Measured: 6 months

  16. Change of dose for treatments assessed by levodopa (L-DOPA) équivalents between the Baseline assessment and the assessment at 6 months' follow up

    Measured: 6 months

  17. Frequency, type and severity of therapy-related adverse events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start15 May 2019
  3. Primary completion2 Jun 2022
  4. Study completion2 Jun 2022

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Interventional to minimal risks and constraints, non randomized, open
Masking
Single blind
Who is masked
Participant
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03693872
Sponsor's protocol ID
35RC18_9721_AGAPO
Acronym
AGAPO
Status last verified
Nov 2023
First submitted
1 Oct 2018
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Apomorphine and Dopaminergic Agonist + Apomorphine in people with Parkinson Disease, run by Rennes University Hospital 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 6 inclusion and 7 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 27 Nov 2023. 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?

Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up (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 27 Nov 2023.

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