Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ML Bio Solutions, Inc.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Completed Study MLB-01-005 on study drug through the final clinic visit (Month 36 or another qualifying end-of-study visit as determined by the Sponsor).
The participant (or parent/guardian) who signs the ICF understands the study procedures and agrees to participate in the study by giving informed consent (or assent, if \<18 years of age).
Is willing and able to complete all study procedures according to the Schedule of Assessments.
A WOCBP or a nonsterile male participant must be willing to use an acceptable method of contraception from the time of consent through 30 days after the last dose of study drug in this study.
You may not be if
Has developed clinically significant concomitant disease that would, in the Investigator's opinion, be likely to unfavorably impact study participation, including:
* Any significant concomitant medical condition, including psychiatric, cardiac, renal, pulmonary, hepatic, or endocrine disease other than that associated with LGMD2I/R9
* Any other significant laboratory, vital sign, ECG abnormality, clinical history, or finding
Is pregnant (based on the Baseline / Day 1 pregnancy test result) and/or breastfeeding or planning to conceive children within the projected duration of the study through 30 days after the last dose of study drug in this study.
Has active suicidal ideation, defined as having a suicide ideation score of 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS at Baseline / Day 1.
Clareo Health | Open-Label Extension Study of BBP-418 (Ribitol) for LGMD2I/R9
