Trials Sponsors Conditions Drugs Pricing

Conditions

Dyskinesia, Drug-Induced Parkinson Disease

Outcome Measures

Primary Outcomes (1)

Assess the effect of two doses of safinamide on reducing levodopa-induced dyskinesia
Change from Baseline to Week 26 in levodopa-induced dyskinesia based on UDysRS total score. The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD
26 weeks

Secondary Outcomes (9)

Assess the effect of two doses of safinamide on ON time with No Dyskinesia
26 weeks
Assess the effect of two doses of safinamide on ON time with non-troublesome dyskinesia
26 weeks
Assess the effect of two doses of safinamide on ON time with troublesome dyskinesia
26 weeks
To assess the effect of two doses of safinamide on ON time with any dyskinesia (troublesome or non-troublesome)
26 weeks
To assess the effect of two doses of safinamide on sleep time
26 weeks
+4 more secondary outcomes

Study Arms (3)

Safinamide 100mg

EXPERIMENTAL

Participants randomized to the 100 mg study arm will receive 100 mg safinamide methanesulfonate film-coated tablets once daily during Week 1 (2 x 50 mg active tablets plus 1 placebo tablet) and throughout the rest of the study safinamide

Drug: Safinamide Methanesulfonate 100mg

Safinamide 150mg

EXPERIMENTAL

Participants randomized to the 150 mg study arm will receive 100 mg methanesulfonate film-coated tablets once daily during Weeks 1 and 2 (2 x 50 mg active tablets plus 1 placebo tablet), and 150 mg methanesulfonate film-coated tablets once daily(3 x 50 mg active tablets) from Week 3 and throughout the rest of the study

Drug: Safinamide Methanesulfonate 150mg

Placebo

PLACEBO COMPARATOR

Interventions

Safinamide Methanesulfonate 150mgDrug

150 mg (free base)

Safinamide 150mg

Safinamide Methanesulfonate 100mgDrug

100 mg (free base)

Safinamide 100mg

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female participants aged 30 years and above at the time of signing the informed consent;
Female participants may participate if they are not of child bearing potential (post-menopausal with no periods for at least one year, or surgically sterilized);

Sponsors & Collaborators

Zambon SpA
Industrylead

MeSH Terms

Conditions

Dyskinesia, Drug-InducedParkinson Disease

Interventions

safinamide

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeurotoxicity SyndromesSigns and SymptomsPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Study Officials

Charlotte Keywood, MD
Zambon SpA
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 17, 2019

Study Start

October 2019

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

Safinamide for Levodopa-induced Dyskinesia (PD-LID)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Safinamide 100mg

Safinamide 150mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Safinamide 100mg

Safinamide 150mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record