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Effect of Safinamide on Parkinson's Disease Related Chronic Pain

NCT03841604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-05-22

Study results available
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Summary

Primary objective:

• To evaluate the potential efficacy of safinamide 100 mg once daily (OD), compared with placebo, as add-on therapy for PD-related chronic pain

Secondary objectives:

* Percentage of pain responders
* Clinical Global Impression for pain
* Patient Global Impression for pain
* Reduction in use of pain drugs
* Mood
* Motor and non-motor symptoms

Safety Objectives:

• Safety and tolerability

Conditions

  • Idiopathic Parkinson Disease

Interventions

DRUG

Safinamide Methanesulfonate

50 mg, 100 mg

OTHER

Safinamide methanesulfonate matching placebo

50 mg, 100 mg

Sponsors & Collaborators

  • Zambon SpA

    lead INDUSTRY

Principal Investigators

  • Charlotte Keywood, MD · Zambon SpA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-09
Primary Completion
2021-04-30
Completion
2021-05-03

Countries

  • Austria
  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841604 on ClinicalTrials.gov