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Parkinson's pump trial aims to keep Early-Stage patients on their feet

NCT ID NCT02864004

Symptom relief Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an apomorphine pump can improve quality of life for people in the early stages of Parkinson's disease who have just started experiencing motor complications. 134 adults aged 65 or younger with mild Parkinson's used either the pump plus standard care or standard care alone for 12 months. The goal was to see if the pump helps maintain daily function and social participation better than pills alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apomorphine
What this could lead to
If it works, this could offer a way to manage motor symptoms earlier in Parkinson's, helping people stay active and independent longer.
What could go wrong
This is a Phase 3 trial, but it's relatively small (134 people) and focuses on early-stage patients, so results may not apply to everyone. The pump requires a continuous infusion, which can cause side effects like nausea or skin reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

134 people

The number who actually took part.

Started

Mar 2017

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • APHM, hospital of Timone

    Marseille, 13385, France

  • Amiens University Hospital

    Amiens, 80054, France

  • Bayonne Côte Basque Hospital

    Bayonne, 64109, France

  • Caen University Hospital

    Caen, 14033, France

  • Caremeau University Hospital

    Nîmes, 30029, France

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63003, France

  • Clinique Beau-Soleil

    Montpellier, 34070, France

  • Hautepierre University Hospital

    Strasbourg, 67098, France

  • Laennec Hospital

    Nantes, 44093, France

  • Lille University Hospital

    Lille, 59037, France

  • Montpellier University Hospital

    Montpellier, 34295, France

  • Nancy University Hospital

    Nancy, 54035, France

  • Pasteur 2 University Hospital

    Nice, 06002, France

  • Pellegrin University Hospital

    Bordeaux, 33000, France

  • Pierre Wertheimer Hospital

    Bron, 69677, France

  • Pitié-Salpêtriere Hospital

    Paris, 75651, France

  • Poitiers University Hospital

    Poitiers, 86021, France

  • Purpan University Hospital

    Toulouse, 31059, France

  • Rennes University Hospital

    Rennes, 35033, France

  • Saint-Etienne University Hospital

    Saint-Etienne, 42055, France

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