View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
  2. Company News
June 19, 2018updated 12 Jul 2022 1:14pm

Teva announces change in ENFORCE Phase III trial of fremanezumab

Teva Pharmaceutical Industries has announced a change in the ENFORCE Phase III clinical development programme of monoclonal antibody fremanezumab in chronic cluster headache.

Teva Pharmaceutical Industries has announced a change in the ENFORCE Phase III clinical development programme of monoclonal antibody fremanezumab in chronic cluster headache.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

A chronic cluster headache study, an episodic cluster headache study, and a long-term safety study are part of the new programme.

Following a pre-specified futility analysis of the chronic cluster headache study, it was found that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met.

During the trial, no safety concerns were observed with fremanezumab treatment.

Teva Pharmaceutical Industries senior vice-president, Global Specialty Clinical Development head Tushar Shah said: “While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology.

“We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial.”

“We would like to thank the patients and investigators for their participation in the Chronic Cluster Clinical Trial.”

Based on the study meeting the futility criteria, the company said it will discontinue the trial for chronic cluster headache.

Patients participating in the long-term safety study will also discontinue their participation. However, the episodic cluster headache study, which is not affected, will continue as planned.

The US Food and Drug Administration (FDA) is currently reviewing fremanezumab, with an action date of 16 September.

It is also being reviewed by the European Medicines Agency (EMA), as a quarterly or monthly injection for the preventive treatment of migraine in adults.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena