CVS HopeClinical Trial

The CVS Hope trial is the first of its kind to evaluate an investigational medication designed specifically to treat Cyclic Vomiting Syndrome

Enrollment for the CVS Hope Clinical Trial has been completed.  We thank everyone who has participated or expressed interest in this important study!

What is Cyclic Vomiting Syndrome (CVS)?

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.

  • CVS symptoms are often triggered by stress and frequently occur “out of the blue”
  • Many people report that episodes occur early in the morning, with some people reporting a seasonal variation to their symptoms
  • CVS can be divided into 4 phases: the prodromal phase, the emetic phase, the recovery phase, and the asymptomatic phase
  • People with CVS might also have other medical conditions such as migraine, anxiety, or depression
  • Many people with CVS are often misdiagnosed as having a stomach flu, food poisoning, or gastroparesis (slow emptying of the stomach)

If you have experienced each of the following, you might have CVS:

  • Episodes of vomiting that come on suddenly and last from 1-6 days,
  • At least 2 of these episodes in the past 6 months and at least 3 episodes in the past year and,
  • Absence of vomiting between episodes (other milder symptoms can be present between episodes)
CVS Cycle
Illustration of CVS phases
Fleisher et al. (2005) BMC Medicine

What is Staccato™ Granisetron

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.

staccato device
Rapid vaporization + Rapid absorption = Rapid onset of action

What is the CVS Hope Trial?

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

What Happens During the Study?

This study has 4 parts: 3 visits and 1 at home treatment period

Screening Visit: See if the study is a good fit for you

  • The study will be explained to you to see if you would like to participate (provide informed consent)
  • We will collect basic information about you (age, sex, height, weight)
  • We will ask questions about your medical history and any medications you are taking or have taken recently
  • We will conduct medical tests (blood tests, urine tests, heart tests, physical exam) to see if you are healthy enough to participate in the study

Visit 2: Health Followup and First Dose

  • We will ask some of the same questions about your health to see if the study is still a good fit for you
  • You will be assigned to receive either 1 mg granisetron, 3 mg granisetron, or placebo (a device with no granisetron in it). What you receive will be randomly assigned by a computerized system and neither you nor the investigator will know what you were assigned to receive until the study is over
  • You will be shown how to use the Staccato device and you will take one dose at the clinic. For the next two hours, we will do heart tests and ask you how you feel
  • We will show you how to use the electronic diary (eDiary) and how to record any side effects that you might experience or medications that you might take during the home treatment period

Home Treatment Period

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:

  • Answer questions on the eDiary before taking study medication
  • Use one dose of your study medication per day for up to 5 days
  • Contact the study site to let them know that you used a dose of study medication
  • Answer questions on the eDiary after taking study medication

Post-dose Visit

The main purpose of this visit is to look at safety after using the study medication

  • We will ask you to return to the study site 3-5 days after you use the study medication to treat a CVS episode
  • We will do blood tests, heart tests, and a physical exam, and ask you about your health and any medications that you might have taken during the home treatment period
  • Your participation will be over at the end of this visit (unless you have any side effects that require additional monitoring or treatment)

Who can join the study?

You might qualify to participate in the CVS Hope study if you:

Are between 18 and 60 years of age
Have received a diagnosis of cyclic vomiting syndrome (CVS)
Are otherwise healthy

You might not qualify if you:

Have a medical or psychiatric condition that would make it unsafe for you to participate
Have a known hypersensitivity or allergy to granisetron or other drugs like granisetron

What if there are no study sites near me?

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:

  • Reimbursement for use of personal vehicle or ground transportation such as Uber, Lyft, or taxi
  • Reimbursement for reasonable meal expenses
  • Other travel-related expenses (parking expenses, tolls)
  • Hotel accommodations (requires sponsor approval)
  • Air travel (requires sponsor approval)

Who is Alexza

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.