Status
Not open for further replies.

Al

Moderator emeritus
Joined
May 25, 2004
Messages
7,960
Reason
PALS
Diagnosis
10/2003
Country
CA
State
On
City
NW of Toronto
In collaboration with Avanir Pharmaceuticals, we're pleased to announce a new research initiative for members diagnosed with ALS experiencing pseudobulbar affect (PBA), also known as emotional lability.

Star Trial

As you know, people living with ALS experience a number of disabling symptoms as a result of their illness. Many experience a neurologic disorder called PBA which is characterized by sudden and unpredictable episodes of crying, laughing or other emotional displays. PBA episodes are often incongruent or exaggerated relative to the patient's inner mood state or social context and can cause anxiety or embarrassment, frequently leading to increased social isolation.

More than a million people in the United States with neurologic diseases or injuries also have PBA — impacting their lives, and the lives of those close to them. An estimated 20% to 50% of patients diagnosed with ALS suffer from PBA episodes.

Presently no medications have been approved by the U.S. Food and Drug Administration for the treatment of PBA. However, Avanir Pharmaceuticals is studying an investigational targeted PBA therapy known as Zenvia™ or AVP-923. The STAR trial, sponsored by Avanir Pharmaceuticals, is currently enrolling 180 adults diagnosed with ALS exhibiting the signs and symptoms of PBA at approximately 40 study sites across the United States. You may be eligible to participate in this clinical research study.

Please visit www.pbatrial.com to learn more about PBA and locate the nearest study site of the STAR trial. You can help make a difference for everyone with ALS!

Regards,

The staff of PLM & Avanir Pharmaceuticals

__________________
Live today like tomorrow may never come.
 
Last edited by a moderator:

Al

Moderator emeritus
Joined
May 25, 2004
Messages
7,960
Reason
PALS
Diagnosis
10/2003
Country
CA
State
On
City
NW of Toronto
I received this today and have no other information on it.

AL.
 

brooksea

Legendary member
Joined
Sep 27, 2006
Messages
5,171
Reason
Other
Country
HM
My husband is participating in the trial at Emory.

the medication is dextromethorphan, the cough suppressant and quinidine.

http://www.clinicaltrial.gov/ct2/show/NCT00573443?term=avanir+pharmaceuticals&rank=1

You must keep a diary of "episodes" of emotional lability. They also have questionnaire for caregiver strain on 2nd vist or baseline visit. pALS will have to answer questionnaire re: depression and PBA to see if they qualify.

the pALS will have to give blood to be analyzed to see if they qualify. Also an ECG will be done during the trial, as quinidine "controls heart rhythms."

Be prepared to be at he facility for a couple of hours.
 

BethU

Extremely helpful member
Joined
May 11, 2008
Messages
2,644
Reason
PALS
Diagnosis
05/2008
Country
US
State
California
City
Los Angeles
That's the clinical study I started on yesterday at UCLA. I can't remember if this study includes a placebo ... it was my understanding originally that they had completed the placebo studies and decided that it was a worthwhile med, and that now they are evaluating the dosage.

Placebo or real med, this stuff is great. I've come out of my funk and actually feel normal again (or as normal as I ever get). And so far (2 days) no outbursts.

BethU
 

brooksea

Legendary member
Joined
Sep 27, 2006
Messages
5,171
Reason
Other
Country
HM
The trial at Emory includes placebo. After the study, participants get the real thing.
 
Status
Not open for further replies.
Top