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HELP MOVE HA RESEARCH FORWARD.

Study Overview

Study participation is expected to last up to 68 weeks and includes 11 study visits. Participation is divided into three parts:

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Screening Period
(up to four weeks) :

You will be asked to read and sign an Informed Consent Form, which contains information about the RESET-HA study, including potential risks and benefits of participating, and your rights as a study participant. During this time, the study doctor will review your medical history and conduct several health-related tests, assessments, and procedures to determine if you are eligible to participate.

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Placebo-controlled Study Treatment Period
(12 weeks) Part I:

You will be randomly assigned (like flipping a coin) to receive the investigational drug or placebo (an inactive substance) every day. You will also attend five study visits to monitor your health and assess the safety and effectiveness of the investigational drug.

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Study Treatment Extension Period
(52 weeks) Part II:

During this period, all study participants will receive the investigational drug. You will attend five study visits to monitor your health and assess the safety and effectiveness of the investigational drug. You will also be contacted by the study staff two weeks after you complete the study to ask how you are feeling.

All study participants will be expected to take their assigned study drug as directed, attend all scheduled study visits, take part in study-related procedures, and follow the instructions of the study doctor and study staff. In addition, all study participants will be required to regularly (daily, weekly, and monthly) enter information about their symptoms of HA in an electronic diary (e-diary).

All eligible study participants will receive at no cost:

Reimbursement for travel-related study expenses may also be available. Speak to a member of the study staff for additional information.