Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
In the double-blind, cross-over part of the study, ODM-109 capsules and placebo capsules for
ODM-109 will be administered for 2 weeks separated by a 19-23 days wash-out period. During
each treatment period of the double-blind cross-over part, there will be a baseline visit
(day 1) and 2 visits (5 ± 2 and 14 ± 2 days) after the start of study treatment. After
completing the 3rd treatment period, the subjects will continue in the open-label follow-up
part for 6 months. During the open-label follow-up, visits will be at 1, 3 and 6 months. An
end-of-study visit will take place 14-25 days after the last study treatment administration
for each subject. The study duration will be about 13-14 weeks for the double-blind
cross-over part, and about 9-10 months for the entire study including the 6 months open-label
follow-up.
The number of randomised study subjects is planned to be approximately 54 in cross-over
comparison. The maximum number of subjects will not exceed 70.
Primary objective is to investigate the efficacy of oral ODM-109 on respiratory function in
patients with amyotrophic lateral sclerosis (ALS).