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Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

NCT03505021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 496

Last updated 2022-05-11

Study results available
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Summary

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

Conditions

Interventions

DRUG

Levosimendan

Levosimendan 1 mg capsule for oral administration

DRUG

Placebo for levosimendan

Placebo capsule for oral administration

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Merja Mäkitalo, CSD · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2020-07-23
Completion
2020-07-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03505021 on ClinicalTrials.gov