Cyclic vomiting syndrome (CVS) is a chronic condition in which people have episodes of severe nausea and vomiting that alternate with periods during which they feel normal.
Granisetron is a drug that blocks the actions of chemicals in the body that can trigger nausea and vomiting.
The Staccato granisetron uses the Staccato One Breath Technology™ (OBT™) to deliver granisetron, which has the advantages of bypassing the GI system and resulting in rapid drug delivery for a fast onset of effect and potential relief of CVS symptoms.
The Staccato OBT system comprises the rapid vaporization of an excipient-free drug to form aerosol particles optimal for systemic delivery through inhalation. These aerosol particles are rapidly absorbed, resulting in peak plasma blood levels obtained in the first few minutes after administration.
The CVS Hope trial is the first of its kind to evaluate a medication designed specifically to treat CVS symptoms
The main purpose of this study is to see if Staccato granisetron can help with CVS and whether Staccato granisetron is safe in people who have CVS
This study will also help us determine what dose(s) of Staccato granisetron might be best for CVS
The main purpose of this part of the study is to see if the study medication that you were assigned helps with a CVS episode
After we know that your ECG (a test that measures and records the electrical activity of your heart) results from Visit 2 look good, you will be provided with the study medication for the Home Treatment Period.
For the next 12 weeks, if you feel a CVS episode coming on, we will ask you to:
The main purpose of this visit is to look at safety after using the study medication
You might qualify to participate in the CVS Hope study if you:
You might not qualify if you:
Travel support is available for people who do not live near a study site
The study sponsor has implemented a program designed to assist participants to attend study visits. A clinical research support company who has experience working with participants in clinical trials will assist you with all travel-related needs and reimbursements for this study.
How does it work? The travel support company will be working with you and your study site representative to make necessary travel arrangements. Your confidentiality will be maintained at all times.
The following travel expenses may be arranged or reimbursed for your traveling needs, as applicable:
The CVS Hope Trial is being conducted at approximately 18 study sites in the US.Find a Trial Location
The CVS Hope Trial is sponsored and funded by Alexza Pharmaceuticals. Alexza Pharmaceuticals is a technologically advanced, forward-thinking and innovative company based in Mountain View, California. We are focused on the research and development of novel, proprietary products for the acute treatment of underserved medical needs.
Alexza has developed the Staccato One Breath Technology™ (OBT™) system, which is a hand-held inhaler designed to deliver a pure drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.