Treatment of amyotrophic lateral sclerosis with high-dose methylcobalamin: phase III clinical trial
Not Applicable
- Conditions
- Amyotrophic lateral sclerosis
- Registration Number
- JPRN-UMIN000029588
- Lead Sponsor
- Tokushima University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in ALSFRS-R scores at 16 weeks
- Secondary Outcome Measures
Name Time Method