Healthy Choices

Sacramento one of 50 sites testing new drug for inner ear disorder

Tamara Cardinal never knows where she’ll be when vertigo attacks. Sometimes it’s in the office, sometimes it’s on the freeway. Wherever she is, she has one crucial minute to get to stable ground before her world starts spinning.

“All you can do is just sit still with your eyes closed,” she said. “You can’t imagine what it feels like. It’s so debilitating.”

Cardinal, 58, suffers from the intense dizziness of vertigo as a result of her Ménière’s disease – an inner ear disorder that causes imbalance, nausea, ringing ears and hearing loss due to inflammation. The disorder affects about 600,000 people nationwide, mostly between the ages of 30 and 70.

While there are currently no FDA-approved drug therapies for Ménière’s disease, Cardinal is one of nine patients locally and hundreds in North America to be receiving treatment for the condition via a clinical drug trial.

The trial is live at 50 sites across the United States and Canada, including the Sacramento Ear, Nose and Throat Surgical and Medical Group Inc., a private practice employing Dr. Kevin McKennan, an expert in Ménière’s disease.

“Our treatment of it in ENT has been difficult and largely unsuccessful,” McKennan said. “It really doesn’t treat the entire condition or do anything to improve the hearing ... all of us in the field are waiting for some future development that will do that.”

The treatment being tested in Sacramento and elsewhere is a gel form of a steroid called Decadron, which was shown in a pilot study at the University of South Carolina to reduce symptoms in 70 percent of Ménière’s patients for up to six months.

While Decadron has proved effective in reducing inflammation in other parts of the body, Ménière’s researchers have had difficulty administering it to the inner ear, where it might slosh around and cause problems in its liquid form, McKennan said. The new treatment combines Decadron with a chemical compound called poloxamer to form a gel with reverse thermal qualities, meaning it begins as a liquid and becomes a semi-solid once heated inside the body. Clinicians inject the liquid into the inner ear, where it then takes three to four weeks to dissolve into the ear drum and begin reducing inflammation, McKennan said.

Cardinal said her symptoms became worse during the two weeks immediately following her injection in May, but began improving drastically after that. Now Cardinal, who lives in the Bay Area and commutes to McKennan’s office, said she has not had a vertigo attack in more than three months.

“It was unbelievably better,” she said. “This is going to work for people. I was kind of skeptical at first, I didn’t know if there was anything that could make it better.”

To be eligible for the trial, which opened in January and will accept participants for the next two months, patients must have a confirmed Ménière’s diagnosis and a referral from a physician. So far, there are nine participants enrolled in Sacramento, more than in any of the 50 participating sites, according to clinical trial coordinator Bryan Hughes.

There are only 39 total Ménière’s-related trials being conducted internationally, said Hughes, a fraction of the number being done for more studied conditions.

Hughes said the current study has been a collaborative effort among the sites, the FDA, the Institutional Review Board and Otonomy Inc., a San Diego-based drug developer specializing in ear medicine, to move the gel closer to FDA approval. In the next stage of testing, patients who received the placebo this time around will be guaranteed to receive the treatment.

“It’s a ‘takes a village’ kind of thing,” Hughes said. “We’re excited about a new treatment outcome – an arrow in a quiver, if you will.”

Patients interested in the clinical trial can visit www.menieresresearchstudy.com or call (866) 331-5157 to see if they qualify.

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