Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
Public ClinicalTrials.gov record NCT03948178. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.
Study identification
- NCT ID
- NCT03948178
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 227 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 26, 2019 (Actual)
- Primary completion
- Nov 18, 2020 (Actual)
- Completion
- Nov 18, 2020 (Actual)
- Last update posted
- Mar 9, 2023
2019 – 2020
United States locations
- U.S. sites
- 31
- U.S. states
- 21
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular research Centre and Neuromuscular Clinic of Arizona | Phoenix | Arizona | 85028 | — |
| University of California San Diego | La Jolla | California | 92037-0886 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| Hospital for Special Care | New Britain | Connecticut | 06053 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| The George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Holy Cross Hospital Neuroscience Institute | Fort Lauderdale | Florida | 33308 | — |
| University of Florida McKnight Brain Institute | Gainesville | Florida | 32611 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| University of South Florida/USF Health | Tampa | Florida | 33612 | — |
| Augusta University, Medical Centre | Augusta | Georgia | 30912 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan, Michigan Medicine University Hospital | Ann Arbor | Michigan | 48109 | — |
| Health Partners Speciality Center | Saint Paul | Minnesota | 55130-5302 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Neurology Associates | Lincoln | Nebraska | 68506 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Columbia Presbyterian Hospital | New York | New York | 10032 | — |
| Neurosciences Institute - Neurology Charlotte | Charlotte | North Carolina | 28207 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1023 | — |
| The Ohio State University Wexner Medical center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97201-3098 | — |
| Providence Brain and Spine Institute | Portland | Oregon | 97213 | — |
| Alleghenay General hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Nerve and Muscle Centre of Texas | Houston | Texas | 77030 | — |
| University of Utah Health-Imaging & Neurosciences Center in research Park | Salt Lake City | Utah | 84132 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03948178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03948178 live on ClinicalTrials.gov.