Væ§ølis
12-27-2003, 02:32 AM
Something started happening to Virginia Kovalovich this year that the nursing supervisor could not explain: Every day, she found herself crying for no reason.
"I could look at a little puppy and start to cry," she said. "It could be something ordinarily pleasant, but the crying wasn't pleasant. It was an automatic response, not easily stopped."
Her doctor, neurologist Alex Rae-Grant, told the 57-year-old Lower Macungie Township woman that her symptoms stem from her multiple sclerosis, which was diagnosed in June 1998.
Patients with neurological disorders such as MS, Lou Gehrig's disease, Alzheimer's and Parkinson's also can develop an uncontrollable reflex for crying or laughing, he said.
"They can't control the reflex, which can be a problem socially or at work," Rae-Grant said. "Imagine being in church and not being able to stop laughing."
Called pseudobulbar affect, the condition affects an estimated 1.5 million Americans.
There is no treatment specific to the condition approved by the U.S. Food and Drug Administration, but Kovalovich is among a handful of local patients participating in a national study of the combination of two drugs previously approved for other conditions.
The new formula, known as AVP-923, combines an ingredient in cough syrup and an old heart medicine, Rae-Grant said. Those medicines are dextromethorphan and quinidine.
In the same way that dextromethorphan can stop the cough reflex, it appears to have potential in stopping the laughing and crying reflex.
"All stem from the emotional centers of the brain," Rae-Grant said. "People talk about laughing till they cry because both reflexes are closely related. The medicine seems to calm that down."
Quinidine, the old heart medicine, inhibits the enzyme that breaks down dextromethorphan, thereby allowing it to remain effective in the body longer.
Kovalovich only had the problem with crying, not laughing, but said she was willing to try almost anything to get relief.
She directs the same-day surgery center at Lehigh Valley Hospital in Allentown and found it increasingly difficult to supervise her employees when she would have to cry every day.
So this summer, she joined one of two studies Rae-Grant is conducting with AVP-923. The study was "blinded", so that neither she nor her doctor would know if she was taking a pill with the active ingredients or an inactive placebo.
The day after she took her first pill, her symptoms went away and have not returned.
"I was probably on the real medicine", Kovalovich said. "But, I said to myself, even if I'm not on it, whatever did it, the medicine or placebo, it was OK."
Kovalovich and four other local patients enrolled in the blinded study will not officially know what they received during the 85-day trial until the study is concluded and the results from 20 participating universities and medical offices are analyzed nationally. The study seeks to enroll 140 adults with MS and pseudobulbar affect.
However, the results compelled Kovalovich in October to enroll in the second trial, in which every participant gets AVP-923 for one year. Thirty-three medical centers hope to enroll 300 adults with MS and other neurological disorders, including stroke.
"I would clearly recommend this to anyone, without a doubt," she said, claiming all the benefits of the combined drugs and no side effects. "I take one pill in the morning and one in the evening."
Side effects are relatively limited, Rae-Grant said, and can include sleepiness and dizziness. People with a history of irregular heartbeats should not take the medicines and some can develop an allergic reaction to the drugs, he said.
His office would like to enroll another 10 patients in either of the two trials.
To be eligible for the studies, participants must be 18 to 68 years old and in otherwise good general health.
If studies are successful and the FDA approves the treatment, AVP-923 will be the first product to control pseudobulbar affect.
While doctors have prescribed antidepressants for the condition in the past, pseudobulbar affect is a distinct disorder and antidepressants can cause other side effects.
"More than 1 million people suffer a loss of quality of life due to the stigma attached to loss of emotional control", said Dr. Richard Smith of the Center for Neurologic Study in San Diego, Calif. "If AVP-923 can help control emotional expression, patients who are wrestling with the day-to-day challenges of their debilitating disease can regain some social stability."
Avanir Pharmaceuticals, a biopharmaceutical company in San Diego, is sponsoring the studies.
For more information, call Rae-Grant at 610-402-8420, or the national toll-free number, 800-669-0281, or visit the Web site www.pseudobulbar.com.
By Ann Wlazelek
Of The Morning Call
read article here (http://www.mcall.com/news/local/all-b1_5studydec26,0,7185971.story?coll=all-newslocal-hed)
"I could look at a little puppy and start to cry," she said. "It could be something ordinarily pleasant, but the crying wasn't pleasant. It was an automatic response, not easily stopped."
Her doctor, neurologist Alex Rae-Grant, told the 57-year-old Lower Macungie Township woman that her symptoms stem from her multiple sclerosis, which was diagnosed in June 1998.
Patients with neurological disorders such as MS, Lou Gehrig's disease, Alzheimer's and Parkinson's also can develop an uncontrollable reflex for crying or laughing, he said.
"They can't control the reflex, which can be a problem socially or at work," Rae-Grant said. "Imagine being in church and not being able to stop laughing."
Called pseudobulbar affect, the condition affects an estimated 1.5 million Americans.
There is no treatment specific to the condition approved by the U.S. Food and Drug Administration, but Kovalovich is among a handful of local patients participating in a national study of the combination of two drugs previously approved for other conditions.
The new formula, known as AVP-923, combines an ingredient in cough syrup and an old heart medicine, Rae-Grant said. Those medicines are dextromethorphan and quinidine.
In the same way that dextromethorphan can stop the cough reflex, it appears to have potential in stopping the laughing and crying reflex.
"All stem from the emotional centers of the brain," Rae-Grant said. "People talk about laughing till they cry because both reflexes are closely related. The medicine seems to calm that down."
Quinidine, the old heart medicine, inhibits the enzyme that breaks down dextromethorphan, thereby allowing it to remain effective in the body longer.
Kovalovich only had the problem with crying, not laughing, but said she was willing to try almost anything to get relief.
She directs the same-day surgery center at Lehigh Valley Hospital in Allentown and found it increasingly difficult to supervise her employees when she would have to cry every day.
So this summer, she joined one of two studies Rae-Grant is conducting with AVP-923. The study was "blinded", so that neither she nor her doctor would know if she was taking a pill with the active ingredients or an inactive placebo.
The day after she took her first pill, her symptoms went away and have not returned.
"I was probably on the real medicine", Kovalovich said. "But, I said to myself, even if I'm not on it, whatever did it, the medicine or placebo, it was OK."
Kovalovich and four other local patients enrolled in the blinded study will not officially know what they received during the 85-day trial until the study is concluded and the results from 20 participating universities and medical offices are analyzed nationally. The study seeks to enroll 140 adults with MS and pseudobulbar affect.
However, the results compelled Kovalovich in October to enroll in the second trial, in which every participant gets AVP-923 for one year. Thirty-three medical centers hope to enroll 300 adults with MS and other neurological disorders, including stroke.
"I would clearly recommend this to anyone, without a doubt," she said, claiming all the benefits of the combined drugs and no side effects. "I take one pill in the morning and one in the evening."
Side effects are relatively limited, Rae-Grant said, and can include sleepiness and dizziness. People with a history of irregular heartbeats should not take the medicines and some can develop an allergic reaction to the drugs, he said.
His office would like to enroll another 10 patients in either of the two trials.
To be eligible for the studies, participants must be 18 to 68 years old and in otherwise good general health.
If studies are successful and the FDA approves the treatment, AVP-923 will be the first product to control pseudobulbar affect.
While doctors have prescribed antidepressants for the condition in the past, pseudobulbar affect is a distinct disorder and antidepressants can cause other side effects.
"More than 1 million people suffer a loss of quality of life due to the stigma attached to loss of emotional control", said Dr. Richard Smith of the Center for Neurologic Study in San Diego, Calif. "If AVP-923 can help control emotional expression, patients who are wrestling with the day-to-day challenges of their debilitating disease can regain some social stability."
Avanir Pharmaceuticals, a biopharmaceutical company in San Diego, is sponsoring the studies.
For more information, call Rae-Grant at 610-402-8420, or the national toll-free number, 800-669-0281, or visit the Web site www.pseudobulbar.com.
By Ann Wlazelek
Of The Morning Call
read article here (http://www.mcall.com/news/local/all-b1_5studydec26,0,7185971.story?coll=all-newslocal-hed)