DISEASE CLASSIFICATION(S):
Amyotrophic Lateral Sclerosis(ALS)
NAME OF CLINICAL TRIAL/STUDY:
Neurodex For Emotional Lability
TRIAL RESULTS:
The trial showed that Neurodex was more effective than either single component in its composition — dextromethorphan or quinidine — in reducing the severity and frequency of episodes of undesired emotional expression, according to a press release from Avanir dated June 20, 2002.
"The data from this study are robust and favor Neurodex over the other treatment arms," James E. Berg, Avanir's Vice President of Clinical and Regulatory Affairs, is quoted as saying in the company's press release. For more information, see the Avanir Web site at http://www.avanir.com.
The company plans discussions with the Food and Drug Administration to work toward drug approval for Neurodex in the treatment of pseudobulbar affect in ALS.
TRIAL UPDATES:
7/19/02:
EMOTIONAL LABILITY STUDY CLOSED
PURPOSE AND RATIONALE:
A double blind, controlled, multicenter phase 2/3 study to assess the safety and efficacy of AVP-923 - Neurodex - in the treatment of pseudobulbar affect in patients with amyotrophic lateral sclerosis. This drug is a combination of dextromethorphan and quinidine.
Avanir Pharmaceuticals of San Diego, Calif., has begun a study to determine the safety and effectiveness of AVP-923 as a potential treatment for pathological laughing and crying (emotional lability) in ALS patients. Pathological laughing and crying is a condition characterized by frequent episodes of laughing or crying out of proportion or incongruous to the underlying emotion of happiness or sadness. Other terms used to describe this condition include pseudobulbar affect, emotionalism, emotional incontinence, emotional discontrol, and excessive emotionalism. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events. Irrespective of its origins, the syndrome can have a number of problematic social consequences, which may depend upon the frequency and intensity of the behavior. In the extreme, pseudobulbar affect can be disabling, in part due to the stigma attached to loss of emotional control.
The basic mechanisms underlying emotional control are unknown. Lesions in a variety of areas of the brain, including the frontal and temporal lobes, have been associated with the occurrence of pathological laughing and crying. Conceptually, it may be useful to think of pseudobulbar affect as an example of a disconnection syndrome which interrupts the normal integration of cortical and brain stem functions. This is a double-blind, controlled, randomized, national, multicenter clinical study. Patients who are eligible for the clinical trial will be in the study for one month.
OPENING DATES:
Jan 15 2001
CLOSING DATES:
Mar 31 2002
TARGET NUMBER OF PARTICIPANTS:
96
RECRUITMENT STATUS:
Closed
ELIGIBILITY REQUIREMENTS:
ALS patients thought to exhibit pseudobulbar affect will be screened for general health within four weeks prior to entry into the study. In order to be included in the study, patients must have clinically diagnosed pseudobulbar affect.
Inclusion criteria:
- age range of 18 to 75
- adequate respiratory function (vital capacity of > 60%)
- women of child-bearing age must be non-pregnant, non-lactating, and practicing an established method of birth control or be surgically sterile
- must have a normal EKG (electrocardiogram).
Exclusion criteria:
- recently diagnosed (within two months) with ALS
- taking antidepressive medication; score of > 16 on the Hamilton Rating Scale for Depression; previous history of torsades de pointe (heart abnormality)
- abnormal EKG.
Investigators will determine eligibility based upon patient interview against protocol-determined criteria.
