Clinical Trials

Inclusion Criteria:

1. Subjects or their legally authorized representative must provide a signed and dated
informed consent form to participate in the study.

2. Subjects must be able (in the judgment of the Investigator) to understand the nature
of the study and all risks involved with participation in the study.

3. Subjects must be willing to cooperate and comply with all protocol restrictions and
requirements.

4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been
compliant with study drug.

Exclusion Criteria:

1. Subjects of childbearing potential unwilling to use an acceptable method of
contraception from the Day 1/screening visit until 3 months after the last dose of
study medication. Subjects who are sexually active who do not agree to use
contraception during the study period.

2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy
test) or lactating at the Day 1/screening visit.

3. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior
or suicidal ideation of type 4 (active suicidal ideation with some intent to act,
without a specific plan) or type 5 (active suicidal ideation with specific plan and
intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of
Study MT-1186-A02.

4. Subjects who are not eligible to continue in the study, as judged by the Investigator
in conjunction with the MTDA medical monitor.

5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.