NCT01291537

Brief Summary

The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

4.3 years

First QC Date

February 7, 2011

Last Update Submit

October 10, 2016

Conditions

Parkinson's Disease

Keywords

AdvancedSevere form

Study Arms (2)

Duodopa

EXPERIMENTAL
Drug: Duodopa

Best medical treatment

ACTIVE COMPARATOR
Drug: best médical treatment

Interventions

DuodopaDRUG
Duodopa
best médical treatmentDRUG
Best medical treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years and ≤ 80 years
  • Akineto-hypertonic and/or tremor forms of Parkinson's disease as defined by the criteria of the French National Consensus conference for Parkinson's disease (March 2000)
  • Absence of parkinsonism other than a Parkinson's disease, including absence of one or more of the following signs: autonomic syndrome, hallucinations, pyramidal signs, early postural instability, early cognitive impairment (including apraxia or severe frontal lobe syndrome) (Consensus Conference, March 2000)
  • Severe and advanced forms of Parkinson's disease with sensitivity to L-dopa (≥ 40%)
  • No contraindication to Duodopa®: hypersensitivity to levodopa and carbidopa, or any of the excipients, angle-closure glaucoma, kidney and liver failures, severe heart failure, severe cardiac arrhythmia, acute stroke, pheochromocytoma, hyperthyroidism, Cushing syndrome, association with non-selective MAOIs and selective MAOIs-A (stop at least 2 weeks before initiation of Duodopa®)
  • Fluctuations in motor performance (with OFF time ≥ 2 hours per day) and/or dyskinesia induced by L-DOPA altering significantly the activities of daily life in spite of an optimized treatment
  • Hoehn and Yahr score \< 4 in best ON
  • Ability to complete a diary of self-evaluation (with the help of another person if necessary)
  • MMSE ≥ 24/30
  • No evolutive psychosis or history of severe psychosis requiring hospitalization
  • No digestive disease or ENT evolutionary
  • No concomitant treatment by continuous infusion of apomorphine
  • No concomitant treatment by deep brain stimulation
  • No serious somatic disease likely to interfere with a good participation to the study, contraindication for gastrostomy
  • Menopause proven or woman of childbearing potential with an effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgery: ligation of the fallopian tubes, hysterectomy, total ovariectomy)

You may not qualify if:

  • Age \<18 and\> 80 years
  • No signature of the informed consent form
  • Patient with no social insurance or who cannot benefit it through a third person in accordance with the French law on biomedical research
  • Population under enhanced protection (i.e minors), pregnant women, breast-feeding women, persons deprived of their liberty by a judicial or administrative decision, people in health and social service, adults under legal protection, and finally patients in emergency situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CH d'Aix en Provence

Aix-en-Provence, 13616, France

Location

Chu Amiens

Amiens, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Chu Lille

Lille, 59037, France

Location

Chu de Limoges

Limoges, 87000, France

Location

Chu de Lyon

Lyon, 69229, France

Location

Chu de Marseille

Marseille, 13354, France

Location

Chu de Nantes

Nantes, 44035, France

Location

Chu de Nice

Nice, 06003, France

Location

Chu de Nimes

Nîmes, 30029, France

Location

Ch Saint Antoine

Paris, 75571, France

Location

Ch La Pitie Salpetriere

Paris, 75651, France

Location

Chu de Poitiers

Poitiers, 86021, France

Location

Chu de Rennes

Rennes, 35033, France

Location

Chu de Rouen

Rouen, 76031, France

Location

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

Chu de Strasbourg

Strasbourg, 67091, France

Location

Chu Bordeaux

Talence, 33404, France

Location

Chu de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(20)