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 |
| Protocol serial number | CL3-04200-006 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | International multicentre randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | Parkinson's disease |
| Intervention | Piribedil versus placebo |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Piribedil |
| Primary outcome measure(s) |
Occurrence and time to develop dyskinesia or other motor complications |
| Key secondary outcome measure(s) |
1. UPDRS III |
| Completion date | 11/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/05/2001 |
| Date of final enrolment | 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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
