Amyotrophic lateral sclerosis
Conditions
Interventions
Intramuscular injection, mechylcobalamin 50 mg twice a week for 16 weeks.
Intramuscular injection, placebo twice a week for 16 weeks.
Sponsors
Tokushima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Definite, probable or probable-laboratory supported in the Updated Awaji criteria. *Within 1-year elapsed time period from disease onset at the start of observation period. *Total ALSFRS-R score was lowered by 1-2 points during the observation period (12 weeks). *Stage 1 or 2 of the severity criteria for ALS. *Able to visit study site for out-patient treatment.
Exclusion criteria
Exclusion criteria: *Tracheostomy. *Experienced non-invasive positive pressure ventilation. *%FVC >= 60%. *Chronic obstructive pulmonary disease. *Edaravone use within 4weeks before starting the observation period. *Initiated newly introduced riluzole therapy after starting the observation period. Or received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation. *Cognitive impairment. *Participated in another clinical study within 12 weeks before starting the observation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ALSFRS-R scores at 16 weeks | — |
Countries
Japan
Contacts
Public ContactYuishin Izumi
Tokushima University Hospital Office of coordinating investigator
Outcome results
None listed