Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT02864004
• Date of registration: 15/07/2016
• Prospective Registration: Yes
• Primary sponsor: Rennes University Hospital
• Public title: Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) EARLY-PUMP
• Scientific title: Apomorphine Pump in Early Stage of Parkinson's Disease
• Date of first enrolment: March 3, 2017
• Target sample size: 134
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02864004
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Sophie DRAPIER, Dr
• Affiliation: Rennes University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults aged = 65 years,

- Idiopathic PD (According to British Brain Bank Criteria) without any other known or
suspected cause of Parkinsonism,

- Hoehn and Yahr stage = 2.5 in the best ON,

- Disease duration = 4 years,

- Presence of fluctuations and/or dyskinesias for no more than 3 years,

- One of the two following forms of impairment :

- Impairment in activities of daily living (MDS-UPDRS II>6) due to PD-symptoms
despite medical treatment in the worst condition or,

- Impairment of social and occupational functioning (measured with SOFAS) due to
PD-symptoms despite medical treatment (51-80%),

- PDQ39 completed,

- Able to understand and remember the component of the study,

- Written informed consent,

- Patients covered with social insurance.

Exclusion Criteria:

- Dementia (MoCA < 22),

- Major uncontrolled depression at the time of assessment (BDI > 25) or Bipolar disease,

- Active hallucinations or history of hallucinations in the past year,

- Need for nursing care,

- Previous use of apomorphine pump treatment,

- History of respiratory depression,

- History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,

- Presence of severe freezing or clinically relevant postural instability leading to
falls during the ON state,

- Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,

- Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, Alanine Amino
Transferase (ALT) and Aspartate Amino Transferase (AST) >2 times the upper limit of
normal),

- Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL),

- Pregnant and breastfeeding women,

- Hypersensitivity to apomorphine or any excipients of the medicinal product,

- Concomitant therapy or within 28 days prior to baseline with : alpha-methyl dopa,
metoclopramide, reserpine, neuroleptics (except Clozapine), methylphenidate, or
amphetamine, intrajejunal Ldopa,

- History or current drug or alcohol abuse or dependencies,

- Patients with a borderline QT interval corrected for heart rate according to Bazett's
formula (QTc) of >470 ms for male and >480 ms for female at screening or history of
long QT syndrome;

- Adults legally protected (under judicial protection, guardianship or supervision),
persons deprived of their liberty.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Apomorphine

Other: Best Medical Treatment

Primary Outcome(s)

Difference in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) summary index between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Secondary Outcome(s)

Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in the Neurologist Global Impression of change (CGI-I) [Time Frame: 12 months]

Change in the Patient Global Impression of Change (PGIC) [Time Frame: 12 months]

Change of dose for treatments assessed by levodopa (L-DOPA) equivalents between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in motor examination during "on" periods (MDS-UPDRS III) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in apathy assessed on the short version of Lille Apathy Rating Scale (LARS) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in cognitive function between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in number of hours per day in the "best ON" state between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in pain assessed on the Visual Analog Scale (VAS) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Epworth Sleepiness Scale [Time Frame: 12 months]

Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 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 12 months' follow up [Time Frame: 12 months]

Change in number of hours per day in "ON" with dyskinesia between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in number of hours per day in "OFF" state between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Frequency, type and severity of therapy-related adverse events [Time Frame: 12 months]

Incremental Cost-Effectiveness Ratio (ICER) [Time Frame: 24 months]

Change in Score of the Non-Motor Symptoms Scales (NMSS) for PD between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up [Time Frame: 12 months]

Skin changes assessed by a clinical exam [Time Frame: 12 months]

Full blood count [Time Frame: 12 months]

Secondary ID(s)

35RC15_9724_EARLY-PUMP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors