Clinical Trials

Inclusion Criteria: 

• Subjects who have consented to participate.
• Subjects who have successfully completed the placebo-controlled 24-week study AV-101- 002 without a treatment-limiting toxicity resulting in discontinuation of study drug.
• Female subjects of childbearing potential who have agreed to continue to use a highly effective form of contraception during the LTE and for at least 30 days after completing or discontinuing study treatment (highly effective forms of contraception are described in Section 7.9).

Exclusion Criteria: 

• Subjects for whom the investigator believes that it would not be in the best interest of the subject to be included in the LTE; e.g., for clinical or social reasons.
• Subjects who were not compliant with study medication in AV-101-002 as assessed by the Investigator.
• Clinically relevant history or current psychological abnormality (including alcohol abuse), psychiatric or neurological illness or autonomic neuropathy, which in the opinion of the Investigator could jeopardize or would compromise the subject’s ability to participate in the trial.
• Recent major surgical intervention which in the opinion of the Investigator would compromise the subject’s ability to participate in the trial.
• Pregnant or breast-feeding females.

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

Eligibility last updated 8/22/22. Questions regarding updates should be directed to the study team contact.