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

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

Recruiting
18-65 years
All
Phase 3

The recruitment period will be 36 months. The duration of the study period will be one year for each patient due to:

  • adjustments of apomorphine pump parameters and oral medication (3 months interval),
  • motor and psychosocial changes which need time to develop and have an impact on QoL.

At the end of the study period, two additional visits at Months 18 and 24 will be performed during an long term follow up to collect QoL and costs related data required to medico-economic analysis.

APOMORPHINE (APO) group:

The apomorphine pump will be installed and adjusted at baseline during a first hospitalization (10 days). Modifications of the hourly flow of the pump and readjustment (reduction) of anti-parkinsonian oral medication will be checked and performed at Months 1, 2, 4, 5, 6, 9 during visits and phone calls, and at month 3 during a 3 days hospitalization. Clinical evaluations will be performed at months 6 and 12.

Control group:

Patients will be treated by optimized medical treatment according to the guidelines of the European Federation of Neurological Societies. Dose adjustments will be done at Months 3, 6, 9. Clinical evaluations will be performed at months 6 and 12.

In both groups, data for medico-economic evaluation will be collected from patients at baseline, Months 6, 12, 18 and 24 for Quality Adjusted Life Year (QALYs) and costs related data from a patient's diary and French Health Insurance database.

Study details
    Parkinson's Disease
    Parkinson's Disease

NCT02864004

Rennes University Hospital

19 February 2024

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