“As we got involved in the work and began to learn more about the patient experience, along with the treatment gaps in what was available, we became compelled to find new solutions as soon as possible.” – Dr. Jim Martinez, Eli Lilly and Company
Dr. Jim Martinez, who practiced psychiatry for several years before joining Eli Lilly and Company in 2006, works with a team to develop new treatments for patients who suffer from cluster headache, which remains an area of high unmet need. Often mistaken for migraine, cluster headache is a debilitating neurologic disease characterized by attacks of excruciating pain, usually behind the eye, and lasting anywhere from 15 minutes to three hours. These attacks can occur from once every other day to eight times a day during a cluster period, leaving patients restless and in severe pain until the attack passes.
“Unlike migraine, during which a person may retreat to their bed or a quiet environment, due to the extreme sensitivity to light and sound, people experiencing a cluster headache attack are often restless and may pace or rock back and forth,” says Dr. Martinez. “They can be highly agitated, but it’s the result of the cluster headache attack, which many clinicians describe as one of the most painful medical conditions to exist.”
Cluster headache is challenging to diagnose because of limited awareness and, for some people, may take many years to receive an accurate diagnosis.
The Driving Force
The past two years have resulted in major medical advances in both migraine and cluster headache, including the first medication in the United States to be approved for both the preventive treatment of migraine and the treatment of episodic cluster headache. This innovation can be credited to the exploration of new solutions based on targeting the underlying biology of these serious neurologic disorders.
In the search for solutions, biopharmaceutical researchers turned to CGRP, a peptide believed to play a role in episodic cluster headache and migraine. During a cluster headache attack, for example, researchers have observed elevated levels of CGRP, which return to normal once the attack passes. Thus, scientists believed if they could find ways to inhibit CGRP in patients, the frequency of cluster headache attacks could be reduced.
The resulting treatments, known as CGRP inhibitors, took years and significant investment to develop. Today, CGRP inhibitors sit at the forefront of treatment options for patients with migraine and are changing the treatment landscape.
In fact, it was only this past June when the U.S. Food and Drug Administration approved the first treatment for episodic cluster headache that reduces the frequency of cluster headache attacks. The approval marks a leap forward for patients, who previously had little to no options available.
Challenges and Looking Ahead
True to its name, episodic cluster headache manifests in phases, and patients can enter remission periods that last three months or longer. Dr. Martinez notes this is a challenge to researchers looking to study new treatments because a potential therapy can only be examined when a patient is experiencing symptoms.
“The clinical trial process to examine treatments for episodic cluster headache can be really long,” he says. “Because symptoms are so excruciating, some patients may be hesitant to participate in a clinical trial that features placebo. Combined with the fact that episodic cluster headache is uncommon to begin with, these challenges mean recruiting enough patients for studies is extremely difficult.”
However, clinical trials are crucial to determining the safety and effectiveness of new medicines, and the patients who take part in these trials help further breakthrough science in a literal way.
“One of the most rewarding aspects of our research is that we’ve also helped raise awareness about cluster headache,” says Dr. Martinez. “For that, I’m grateful because wider recognition is the first step toward pursuing additional and much-needed research in this area.”
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