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

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

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
450
Phase:
3
Treatment Type:
Drug: Levosimendan
Trial Type:
Randomized, parallel assignment, Quadruple masking
Sponsor:
Orion Corporation, Orion Pharma
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
SVC between 60-90%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
12-48 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
no
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
no
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

7/9/2018Now recruiting at more than 12 sites in 4 countries.
4/20/2018Trial added

Locations:

Neuromuscular Research Center and Neuromuscular Cl, Phoenix, 85028
Colorado Springs Neurological Associates, Colorado Springs, 80907
Providence Holy Cross Medical Center, Fort Lauderdale, 32209
University of South Florida, Tampa, 33612
Washington University School of Medicine, St. Louis, 63110
Nerve & Muscle Center of Texas, Houston, 77030
Centre Hospitalier Régional de la Citadelle, Liège
Algemeen Ziekenhuis St. Lucas Gent, Gent
Hospital Universitari de Bellvitge, Barcelona
Hospital Universitario y Politécnico de La Fe, Valencia
Norrlands Universitetssjukhus, Umea
Karolinska Universitetssjukhuset, Stockholm

Other Information:

Purpose: 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).
Eligibility: 18 to 120 years, all genders, not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum: View Forum Link
First Published on Clinicaltrials.gov: 4/16/2018
ClinicalTrials.gov ID: NCT03505021
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov