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

Parkinson's Disease Clinical Trial

Official title: Apomorphine Pump in Early Stage of Parkinson's Disease

Status Active, not recruiting

Clinical Trial Summary

The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT02864004
• Study type: Interventional
• Source: Rennes University Hospital
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 3, 2017
• Completion date: January 30, 2025