Condition category
Nervous System Diseases
Date applied
07/02/2006
Date assigned
31/03/2006
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Olivier Rascol

ORCID ID

Contact details

Institut National de la Santé et de la Recherche Médicale (INSERM) U317
Pharmacologie Médicale et Clinique
Faculté de Médecine
37 Allée Jules Guesdes
Toulouse
31073
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-04200-006

Study information

Scientific title

Early treatment of idiopathic Parkinson's disease with dopaminergic agonist piribedil in monotherapy. A two-year randomised, parallel, placebo-controlled study in idiopathic Parkinsonian de novo patients

Acronym

REGAIN

Study hypothesis

To compare the therapeutic effects of piribedil to placebo, on motor symptoms of idiopathic Parkinson's disease (PD) in the early stage of the disease in out-patients naive to L-dopa

Ethics approval

First Ethics Committee approval on 27/11/2000 in Argentina

Study design

International multicentre randomised double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Parkinson's disease

Intervention

Piribedil versus placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Piribedil

Primary outcome measures

Occurrence and time to develop dyskinesia or other motor complications

Secondary outcome measures

1. UPDRS III
2. UPDRS II
3. Time to therapeutic failure
4. Percentage of patients requiring treatment with L-dopa
5. L-dopa daily dose
6. UPDRS IV
7. Other motor scores
8. Quality of life

Overall trial start date

10/05/2001

Overall trial end date

11/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Out-patients between 30 to 77 years old, with stage 1 to 3 (Hoehn and Yahr) and less than six weeks of previous L-dopa treatment, with less than 3 months of previous treatment by a dopaminergic agonist

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients frequently falling according to unified Parkinson's disease rating scale (UPDRS) II and/or III
2. Prior experience of a dopaminergic complication
3. Prior neurosurgery for PD
4. Previous history of freezing
5. Suspected autosomal juvenile Parkinsonism
6. Atypical Parkinsonian symtoms caused by drugs, metabolic disorders or encephalitis
7. History of psychotic symptoms
8. Poor cognitive performance

Recruitment start date

10/05/2001

Recruitment end date

11/08/2004

Locations

Countries of recruitment

Argentina, France, India, Mexico, Portugal, South Africa, Spain

Trial participating centre

Institut National de la Santé et de la Recherche Médicale (INSERM) U317
Toulouse
31073
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Current version as of 28/03/2018:
Summary results are published in https://clinicaltrials.servier.com.
For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.

IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Previous version as of 24/01/2018:
Publication plan:
All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study.
Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ if a Marketing Authorisation has been granted after 2014.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

http://clinicaltrials.servier.com/wp-content/uploads/CL3-04200-006_synopsis_report.pdf

Publication summary

Publication citations

Additional files

Editorial Notes

18/04/2018: Internal review 28/03/2018: The publication and dissemination plan has been changed. 24/01/2018: Publication plan and IPD sharing statement added. 04/12/2017: results summary added.