Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Public ClinicalTrials.gov record NCT03505021. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03505021
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 496 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 21, 2018 (Actual)
- Primary completion
- Jul 23, 2020 (Actual)
- Completion
- Jul 23, 2020 (Actual)
- Last update posted
- May 11, 2022
2018 – 2020
United States locations
- U.S. sites
- 48
- U.S. states
- 25
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Neurological Associates | Phoenix | Arizona | 85006 | — |
| Neuromuscular Research Center and Neuromuscular Clinic of Arizona | Phoenix | Arizona | 85028 | — |
| University of California San Diego | La Jolla | California | 92037-0886 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California Irvine | Orange | California | 92868 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Hospital for Special Care | New Britain | Connecticut | 06053 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion | Washington D.C. | District of Columbia | 20037 | — |
| Providence Holy Cross Medical Center | Fort Lauderdale | Florida | 33308 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| University of Florida Health - Jacksonville | Jacksonville | Florida | 32209 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| Kentucky Neuroscience Research | Louisville | Kentucky | 40202 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 49007 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| HealthPartners Specialty Center | Saint Paul | Minnesota | 55130-5302 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Neurology Associates | Lincoln | Nebraska | 68506 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| 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 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1023 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97201-3098 | — |
| Providence Brain and Spine Institute | Portland | Oregon | 97213 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | — |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Texas Neurology | Dallas | Texas | 75214 | — |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | — |
| University of Utah - Imaging & Neurosciences Center | Salt Lake City | Utah | 84108 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03505021, 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 May 11, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03505021 live on ClinicalTrials.gov.