Zenvia(TM)

Background
Pseudobulbar affect (PBA), also known as involuntary emotional expression disorder (IEED) and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays.

Zenvia is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.

The objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of dextromethorphan/quinidine (AVP-923) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population.

Study Details
This is a double blind, randomized, placebo-controlled, multicenter study to assess the safety, efficacy and pharmacokinetics of two doses of AVP-923 (dextromethorphan/quinidine) in the treatment of pseudobulbar affect in patients with amyotrophic lateral sclerosis and multiple sclerosis.

Contact
Kate Bednarz, RD, (212) 305-2027 or kbednarz@neuro.columbia.edu