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Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study

Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002010-38-DE
Enrollment
80
Registered
2006-02-10
Start date
2005-11-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Parkinson´s Disease

Interventions

Product Name: Trivastal Product Code: S 90049 Pharmaceutical Form: Orodispersible tablet INN or Proposed INN: Piribedil Current Sponsor code: S 90049 Concentration unit: mg milligram(s) Concentration

Sponsors

Institut de Recherches Internationales Servier (I.R.I.S.)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients, male or female, aged 35-75 years, fulfiling the U.K.P.D.S.B.B. criteria for the diagnosis of Parkinson´s disease, disease stage I-III in ON state according to the modified Hoehn and Yahr classification, patients treated with l-dopa and a dopamine agonist drug (up to th maximal recommended dosage). Other non dopamin agonist antiparkinsonian medications are allowed except apomorphine and dispersible Modopar, good therapeutic response to L-dopa complicated with incapacitating motor fluctuations, subjects with at least 3 hours of OFF time daily despite optimized oral antiparkinsonian medications Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients presenting with sudden (switches ON-OFF or OFF-ON within 1 minute), and unpredictable ON-OFF phenomena, currently treated with subcutaneous injections of apomorphine, patients with symptomatic orthostatic hypotension, patients with history of invasive hallucinations (non-critical, durable, threatening) and/or episodes confusion, patients with psychosis, dementia and chronic neurologic disorders other thzan Parkinson´s disease non-authorized concomitant treatment : Modopar dispersible, apomorphine, neuroleptics (antiemetic and antipsychotic)

Design outcomes

Primary

MeasureTime frame
Main Objective: Assessment of the acceptability of a sublingual formulation of piribedil;Secondary Objective: Global assessment of efficacy;Primary end point(s): Acceptability based on the occurence of adverse events—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026