Zosano Pharma has started enrolment in a Phase II/III clinical trial being conducted to assess C213 for the acute treatment of adults with cluster headache.

C213 is an investigational formulation of zolmitriptan and is delivered using the company’s ADAM patch technology. ADAM is made of titanium micro-projections that are coated with the drug.

The randomised, double-blinded, multi-centre, placebo-controlled Phase II/III trial will assess the safety and efficacy of C213 compared to placebo in a total of 120 patients.

Participants will be treated with 1.9mg or 3.8mg of C213 or placebo.

Cluster headache is a neurological condition causing severe unilateral temporal and orbital pain that lasts from 15 minutes to three hours. Patients may suffer cluster headache episodes up to eight times per day.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Currently, more than 300,000 people in the US suffer from the debilitating neurological condition.

Zosano Pharma Clinical Development and Medical Affairs vice-president Dr Don Kellerman said: “We are pleased to expand the application of our ADAM microneedle technology beyond our lead development indication for the acute treatment of migraine with this advanced stage clinical study in cluster headache.

“This population suffers from excruciating and debilitating pain and has limited effective treatment options with no new FDA-approved drugs for the acute treatment of cluster headache since the 1990s.”

The trial’s co-primary endpoints are the proportion of participants experiencing pain relief at 15 minutes and the proportion of patients who have pain relief maintained from 15 to 60 minutes.

The trial will also measure multiple secondary outcomes, including incidence of adverse events and serious adverse events, pain freedom and use of rescue therapy.

Kellerman added: “We are excited that the clinically significant pain freedom and relief observed in our migraine trial will potentially also be demonstrated in the cluster headache clinical trial.”