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
| ISRCTN | ISRCTN36646813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36646813 |
| Secondary identifying numbers | CL3-04200-006 |
- Submission date
- 07/02/2006
- Registration date
- 31/03/2006
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Olivier Rascol
Scientific
Scientific
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
Study information
| Study design | International multicentre randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | First Ethics Committee approval on 27/11/2000 in Argentina |
| Condition | Parkinson's disease |
| Intervention | Piribedil versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Piribedil |
| Primary outcome measure | 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 study start date | 10/05/2001 |
| Overall study end date | 11/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| 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 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
Study participating centre
Institut National de la Santé et de la Recherche Médicale (INSERM) U317
Toulouse
31073
France
31073
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |
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.
