A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005861-21-IT

Enrollment

500

Registered

2007-01-05

Start date

2007-06-11

Completion date

Unknown

Last updated

2013-01-07

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

Conditions

Patients with idiopathic Parkinson's disease with motor fluctuations MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: Safinamide Product Code: NW-1015 Pharmaceutical Form: Tablet INN or Proposed INN: Monoamine oxidase B inhibitors Concentration unit: mg milligram(s) Concentration number: 50- Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patient completed 24 weeks of treatment in Study 016, or if the patient discontinued prematurely, they returned for all scheduled efficacy evaluations, at Weeks 12 and 24 as part of the Retrieved Dropout (RDO) population. 2. The patient was compliant with taking study medication in Study 016. 3. The patient is willing to participate in the study and signed an approved Informed Consent form. Are the trial subjects under 18? no Number of subjects for this age range: 0 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: 1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in this study. 2. The patient has shown clinically significant deterioration during participation in Study 016. 3. The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary efficacy variable: Mean change in Dyskinesias Rating Scale (DRS) during `??on' time from baseline (Study 016) to endpoint (last visit in Study 018).;Secondary Objective: Secondary efficacy variables: Change in ON time (ON + ON minor dyskinesia) as compared to baseline. • Diary Responder Rate at 12 months (primary), and 18, and 24 months (secondary) on the ITT and mITT populations and on the subset of those patients who completed the 2-year treatment period: o Improvement in ON time + ON time with minor dyskinesia, with no increase in troublesome dyskinesia with respect to baseline, o Lack of worsening (`?¤ 30 min) in ON time + ON time with minor dyskinesia, with no increase in troublesome dyskinesia with respect to baseline. • UPDRS IV total score (primary) and, if significant, items 32-35 and 32-34 taken individually and as subgroups (secondary), change from baseline. • Time to develop troublesome dyskinesia (> 30-minute increase of troublesome dyskinesia compared to baseline). • Time to develop any (minor and/or troublesome) dyskinesia (> 30-minute increase of dyskinesia compared to baseline). See protocol page 3.;Primary end point(s): Primary efficacy variable: Mean change in Dyskinesias Rating Scale (DRS) during `??on' time from baseline (Study 016) to endpoint (last visit in Study 018).	—

Measure

Time frame

Main Objective: Primary efficacy variable: Mean change in Dyskinesias Rating Scale (DRS) during `??on' time from baseline (Study 016) to endpoint (last visit in Study 018).;Secondary Objective: Secondary efficacy variables: Change in ON time (ON + ON minor dyskinesia) as compared to baseline. • Diary Responder Rate at 12 months (primary), and 18, and 24 months (secondary) on the ITT and mITT populations and on the subset of those patients who completed the 2-year treatment period: o Improvement in ON time + ON time with minor dyskinesia, with no increase in troublesome dyskinesia with respect to baseline, o Lack of worsening (`?¤ 30 min) in ON time + ON time with minor dyskinesia, with no increase in troublesome dyskinesia with respect to baseline. • UPDRS IV total score (primary) and, if significant, items 32-35 and 32-34 taken individually and as subgroups (secondary), change from baseline. • Time to develop troublesome dyskinesia (> 30-minute increase of troublesome dyskinesia compared to baseline). • Time to develop any (minor and/or troublesome) dyskinesia (> 30-minute increase of dyskinesia compared to baseline). See protocol page 3.;Primary end point(s): Primary efficacy variable: Mean change in Dyskinesias Rating Scale (DRS) during `??on' time from baseline (Study 016) to endpoint (last visit in Study 018).

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Countries

Italy

Outcome results

None listed

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