If you or someone you know has ever suffered from a migraine, you know how debilitating they can be. Now, clinical trials on a drug that prevents migraines are showing promising results. Researchers are testing an antibody that basically attacks the molecule that causes migraines.
Bianca Harris’ migraines started two years ago. She gets them five days a week.
Harris told Ivanhoe, “I’m lucky sometimes it doesn’t come on for like an hour and kind of fools me for a little bit. But yeah, they’re always there.”
She’s a patient of David Kudrow, M.D., director of the Neurological Research Institute of Southern California in Los Angeles. She hopes to get into his study of ALD 403, an antibody targeting a peptide that triggers migraine pain. It’s in an IV given every three months.
“The studies that have been reported so far show that it is effective in reduction of frequency, intensity, duration of migraines, and it reduces the amount of medication that patients will need acutely to treat their migraines,” explained Dr. Kudrow.
The most recent results show that 33 percent of patients taking the higher dose of the drug report a 75 percent reduction in their number of migraine days.
“It would be wonderful if I could just go back to having a normal life and be productive and not have to worry about if I’m out doing something if I am going to have a terrible headache,” said Harris.
She has high hopes for this drug because nothing else has worked for her.
Alder Biopharmaceuticals just wrapped up its Phase 2B trial and is about to enter the final phase of testing before going to the FDA for approval. It is one of four pharmaceutical companies developing a drug to prevent migraines.
Contributors to this news report include: Cyndy McGrath, Supervising Producer; Wendy Chioji, Field Producer; Milvionne Chery, Assistant Producer; Roque Correa, Editor; Rusty Reed, Videographer.
BACKGROUND: Nearly one in four U.S. households includes someone with migraine. Approximately 36 million Americans suffer from migraines. A migraine causes severe throbbing or a pulsing sensation usually on just one side of the head and is often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can last for hours to days and can be so severe that the pain is disabling. Auras are visual disturbances, such as flashes of light or wavy, zigzag vision. Migraines are most common between the ages of 25 and 55.
MIGRAINE TRIGGERS: A number of factors may trigger migraines. One is those factors can be hormonal changes in women. Women with a history of migraines often report headaches immediately before or during their periods, and hormonal medications, such as oral contraceptives and hormone replacement therapy, may worsen migraines. Foods such as aged cheeses, salty foods, processed foods and food additives may trigger migraines. Skipping meals can trigger attacks. Alcohol, especially wine, and highly caffeinated beverages may trigger migraines. Missing sleep, getting too much sleep or jet lag may trigger migraines in some people. Also a change of weather or barometric pressure can prompt a migraine.
NEW TECHNOLOGY: Clinical trials are currently being conducted for a new drug that may prevent migraines. ALD403 is an antibody targeting a peptide that can trigger migraine pain. The study calls for an IV of it given every three months. In the study randomized groups of approximately 120 patients each received ALD403 in either 10 mg, 30 mg, 100 mg, or 300 mg doses intravenously. A final group of approximately 120 patients received a placebo intravenously. At the 12-week mark, 33% and 31% of patients who received a single intravenous dose of 300 mg and 100 mg ALD403, respectively, had a 75% reduction in migraine days and a significant reduction in migraine days.
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David Kudrow, M.D, Director of the Neurological Research Institute of Southern California, talks new clinical trials for drugs trying to prevent migraines with few side effects.
Interview conducted by Ivanhoe Broadcast News in November 2016.
Tell us a little bit about the study that you’re doing for migraine prevention?
Dr. Kudrow: Well just as sort of a background I think we do have very effective acute treatments for migraine. For about the past twenty five years, revolutionary advance in the treatment of migraine with the development of a class of medications called triptans, suma triptan being the first one, very effective acute treatment for migraine. But what we have not had, what we have lacked over the past many years is an effective and well tolerated preventive treatment. These new medications that are being developed currently and the study that we are involved in currently is looking at a medication that is specifically designed to treat migraine. Remember that all the medications we have used up until now for preventive treatment of migraine have been drugs that were developed for other purposes, for epilepsy, for depression, for blood pressure control and essentially co-opted for migraine because they were found by serendipity to be somewhat effective for migraine as well. But always at a cost and the cost is side effects and tolerability. Now we are in the midst of this I would say revolution in development of a class of medications called anti CGRP monoclonal antibodies that are directly targeted for the migraine mechanism.
How does it work?
Dr. Kudrow: What we’ve come to understand through a lot of research and significant advances in research in the understanding of migraine is that the main inflammatory mediator in migraine is this peptide or small protein called CGRP calicitonin and gene related peptide. If we can block CGRP in its activity in migraine then we can control the occurrence of migraine attacks. This particular class of medications is a monoclonal antibody, these are essentially mimicking what the body’s own immune system does. Is it creates antibodies that is targeted against the invading organisms and in this case they’re engineered to target the CGRP molecule, the protein itself or the receptor. If we can very specifically target this CGRP protein then hopefully we can prevent the occurrence of migraines and not cause a lot side effects. That seems to be what we’re seeing in the early phases of the study.
It sounds like it’s kind of working like immunotherapy in cancer, drugs blocking the pathway?
Dr. Kudrow: In a sense it is. I think the advantage is that you can develop a very targeted treatment. We’re not mobilizing the body’s own immune system, which is pretty much what immunotherapy really is about this is actually taking almost a passive immunity. We’re infusing or we’re injecting an antibody. We’re using the same technology that the immune system uses but it’s not, I wouldn’t call it exactly immunotherapy.
How effective is it?
Dr. Kudrow: It’s effective. The studies that have been reported so far show that it is effective in reduction of frequency, intensity, duration of migraines and it reduces the amount of medication that patients will need acutely to treat their migraines.
Where are you in the trials, in getting it approved and getting it out to folks?
Dr. Kudrow: Most of the companies that are developing these antibodies are in Phase III. That is the last phase of development before they take their data to the FDA for approval.
So time line?
Dr. Kudrow: Impossible to say.
It’s hard to say because it’s the FDA. How bad is the problem of migraine in the US and the world, any kind of statistics you might have.
Dr. Kudrow: Migraine is a very, very common condition. It’s estimated that probably 36 million Americans have migraine. It’s very, very common. You can hardly throw a rock in the city without hitting somebody who has migraines, it’s extremely common. It’s a potentially debilitating condition at least episodically debilitating. Migraines are a very severe headache; they certainly take people out of work or out of school or out of their social life temporarily. There is a social cost, there is a productivity cost and of course there’s a medication cost. There’s also a personal cost that it can certainly trigger anxiety in some people that have it. Not knowing when they’re going to have their next migraine attack or how they’re going to be able to function.
Talk a little bit about Bianca who said that five out of seven days she’s got a migraine. How could she benefit or could she benefit from this trial?
Dr. Kudrow: Well potentially she’s a great potential participant in one of these studies. If successful it would significantly relieve her burden of headache and allow her to function in a more normal way. She would be an excellent candidate for this particular study on chronic migraine.
When talking to her and how limiting it is, it limits her life it’s going to be life changing when it gets out in the public.
Dr. Kudrow: Correct, I’ve heard several patients actually endorse that as a benefit of the medication. That it actually reduces the frequency and the intensity of their headaches to such a significant degree that they feel it’s life changing. Our goal is not to eliminate migraines completely that would be very difficult to do although I’m sure there are some patients who respond almost 100 percent. But we’re really looking for a significant reduction in the frequency, intensity, duration of headaches and the amount of medication people use acutely to treat their headaches.
How is it administered?
Dr. Kudrow: The medication is administered intravenously every three months. It’s a infusion the patient comes in to the office. A nurse administers the medication. Puts an IV line in the patient’s arm and infuses the medication over a period of thirty minutes. Then we watch the patient for four hours after that and then off they go.
END OF INTERVIEW
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