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

NCT02864004 | Unknown Phase 3

• 1 other identifier: 35RC15_9724_EARLY-PUMP
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Parkinson's Disease

Keywords

Parkinson disease; Quality of Life; Apomorphine infusion

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (25)

• Change in the Patient Global Impression of Change (PGIC)

  12 months

• Change in the Neurologist Global Impression of change (CGI-I)

  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

  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

  12 months

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

  12 months

Study Arms (2)

APO group

EXPERIMENTAL

An apomorphine pump will be installed and adjusted. The target dose corresponds to the patient's individual optimized dose :maximum dose of 10 mg/hour for 16 hours

Drug: Apomorphine

Control group

ACTIVE COMPARATOR

Patients will be optimally treated with oral dopaminergic therapy to obtain the best medical treatment (BMT) defined as the most efficient single treatment options or their combination.

Other: Best Medical Treatment

Interventions

Apomorphine DRUG

Apomorphine (5 mg/ml) is supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate is adjusted during the whole duration of the study to doses of minimum 3 mg/hour up to a maximum of 10 mg/hour

Also known as: Apokinon

APO group

Best Medical Treatment OTHER

Most efficient single treatment of Parkinson's disease symptoms or their combinations, in concordance with the guidelines of the European Federation of Neurological Societies

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (20)

Amiens University Hospital

Amiens, 80054, France

Location

Bayonne Côte Basque Hospital

Bayonne, 64109, France

Location

Pellegrin University Hospital

Bordeaux, 33000, France

Location

Pierre Wertheimer Hospital

Bron, 69677, France

Location

Caen University Hospital

Caen, 14033, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

Lille University Hospital

Lille, 59037, France

Location

APHM, hospital of Timone

Marseille, 13385, France

Location

Clinique Beau-Soleil

Montpellier, 34070, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Nancy University Hospital

Nancy, 54035, France

Location

Laennec Hospital

Nantes, 44093, France

Location

Pasteur 2 University Hospital

Nice, 06002, France

Location

Caremeau University Hospital

Nîmes, 30029, France

Location

Pitié-Salpêtriere Hospital

Paris, 75651, France

Location

Poitiers University Hospital

Poitiers, 86021, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

Saint-Etienne University Hospital

Saint-Etienne, 42055, France

Location

Hautepierre University Hospital

Strasbourg, 67098, France

Location

Purpan University Hospital

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Study Officials

• Sophie DRAPIER, Dr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 11, 2016
• Study Start: March 3, 2017
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (20)