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NCT03505021 · ClinicalTrials.gov registry record · Phase 3
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
A Phase 3 study, sponsored by Orion Corporation, Orion Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 496
- Enrollment target
NCT03505021 is a Phase 3 study that has completed, run by Orion Corporation, Orion Pharma. The registered enrollment target is 496 participants.
The verdict
NCT03505021, a Phase 3 study, has completed, sponsored by Orion Corporation, Orion Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 496 participants
- Enrollment target
Study 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.
Interventions
- DRUG Levosimendan
- DRUG Placebo for levosimendan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2018-06-21 |
| Est. Completion | 2020-07-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03505021
The ClinicalTrials.gov registry entry for NCT03505021 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orion Corporation, Orion Pharma, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Levosimendan is the first listed.
NCT03505021 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03505021 about?
NCT03505021 is a clinical study titled "Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS". 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...
What is the current status of trial NCT03505021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2018-06-21. Estimated completion is 2020-07-23.
What interventions are being tested in trial NCT03505021?
The interventions under investigation include: Levosimendan (DRUG), Placebo for levosimendan (DRUG).
Who is sponsoring clinical trial NCT03505021?
This trial is sponsored by Orion Corporation, Orion Pharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
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