Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (REFALS)
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|ClinicalTrials.gov Identifier: NCT03505021|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
In the randomized, double-blind, placebo-controlled, parallel-group, multicentre study, ODM-109 capsules and placebo capsules for ODM-109 is administered for 48 weeks. The subjects are allocated to 2 parallel groups receiving either levosimendan 1-2 mg daily or placebo in 2:1 ratio. There is a screening visit, a baseline visit followed by visits at 2, 4, 8, 12, 24, 36 and 48 weeks, and telephone contacts during weeks 18, 30 and 42. An end-of-study visit takes place 14-25 days after the last study treatment administration for each subject. The total study duration for each subject is about 51-52 weeks including the end-of-study visit.
The planned number of study subjects is approximately 450.
Primary objective is to confirm that levosimendan can significantly improve respiratory function in patients with amyotrophic lateral sclerosis (ALS).
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Levosimendan Drug: Placebo for levosimendan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS|
|Estimated Study Start Date :||June 11, 2018|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks
Levosimendan 1 mg capsule for oral administration
Other Name: ODM-109
Placebo Comparator: Placebo for levosimendan
Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.
Drug: Placebo for levosimendan
Placebo capsule for oral administration
Other Name: Placebo for ODM-109
- Supine slow vital capacity SVC [ Time Frame: the change from baseline at 12 weeks ]Pulmonary assessment
- Combined assessment of ALSFRS-R function and survival through 48 weeks [ Time Frame: the change from baseline at 48 weeks ]Scale
- Time to respiratory event through 48 weeks [ Time Frame: the change from baseline at 48 weeks ]Pulmonary assessment, scale
- CGI at 48 weeks [ Time Frame: the change from baseline at 48 weeks ]Scale
- Change from baseline in respiratory function of ALSFRS-R at 48 weeks [ Time Frame: the change from baseline at 48 weeks ]Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505021
|Contact: Merit E Cudkowicz, MD||+1 617 726 2383||Cudkowicz.Merit@mgh.harvard.edu|
|Contact: Merja Mäkitalo, CSD||+358 50 email@example.com|
|Study Director:||Merja Mäkitalo, CSD||Orion Corporation, Orion Pharma|