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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT03693872
• Date of registration: 01/10/2018
• Prospective Registration: Yes
• Primary sponsor: Rennes University Hospital
• Public title: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals AGAPO
• Scientific title: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
• Date of first enrolment: May 15, 2019
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03693872
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Marc VERIN, PH
• Affiliation: Rennes University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Apomorphine

Drug: Dopaminergic Agonist + Apomorphine

Primary Outcome(s)

Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Secondary Outcome(s)

Change in emotional function assessed by the short form of the TEIQue between the Baseline assessment and the assessment at 6 months' follow upscale [Time Frame: 6 months]

Change in motor examination with the Hoehn & Yarr scale [Time Frame: 6 months]

Change in motor examination with the Schwab and England scale between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change in cognitive function assessed by the MoCA scale between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change of dose for treatments assessed by levodopa (L-DOPA) équivalents between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

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 [Time Frame: 6 months]

Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Frequency, type and severity of therapy-related adverse events [Time Frame: 6 months]

Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

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) [Time Frame: 6 months]

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 [Time Frame: 6 months]

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 [Time Frame: 6 months]

Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up [Time Frame: 6 months]

Secondary ID(s)

35RC18_9721_AGAPO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors