Researchers Recruiting People with Cluster Headaches for Antibody Clinical Trial
Monoclonal antibodies could be a whole new class of therapies to treat debilitating episodic or chronic cluster headaches. For this reason, researchers are actively recruiting patients for an international, multicenter and randomized trial to evaluate the safety and effectiveness of one of these agents, galcanezumab, through the Department of Neurology at the University of Miami Miller School of Medicine.
“These cluster headaches are very disabling disorders and cause some of the worst pain known to man,” said Teshamae Monteith, M.D., assistant professor of clinical neurology and chief of the headache division.
The Phase 3 clinical trial offers patients access to a potentially effective treatment prior to full FDA approval, as well as a chance to help others prevent cluster headaches now and in the future. After screening and informed consent, participants will record the frequency of their headaches in an electronic diary to determine their baseline severity. Investigators will then randomly assign appropriate candidates to three subcutaneous injections of either galcanezumab or a placebo. The treatment phase will be eight weeks for people with episodic cluster headaches and 12 weeks for those with chronic cluster headaches. Researchers plan an additional open label phase to allow all participants to receive active treatment for up to 52 weeks.
“Clearly we need better options,” Monteith said. Even though sumatriptan can treat an oncoming migraine or cluster headache for many patients, the goal is to develop preventive therapy. Also, some patients do not tolerate or respond to existing preventive treatments. That’s where monoclonal antibodies could have a role.
Sumatriptan may work in part by decreasing levels of the calcitonin gene-related peptide (CGRP) released in large amounts during a migraine or cluster headache. Monoclonal antibodies show promise because they can bind to the CGRP molecule in advance and thereby prevent excess CGRP from triggering the trigeminal vascular pain associated with these headaches.
There are currently four monoclonal antibody therapies “racing toward approval for migraines,” Monteith said. “It’s very exciting. This could be a paradigm shift for treating cluster headaches, too.”
For more information or to refer a patient for consideration for the study, please call or email study coordinator Mario Perez at MPerez20@med.miami.edu or call (305) 243-7043.