21.Apr.2014

Site initiation has been started in alcohol disorder study

OCT has started site initiation for the phase III study in patients with alcohol disorder.

This is a double-blind placebo controlled randomized parallel-group multi-centre clinical study to access efficiency and safety conducted in adaptive design with two periods in patients with alcohol abuse.

The main study objective is to demonstrate therapeutic efficacy of the investigational product, which is nasal drops, in patients suffering from alcohol disorder, according to one of the two criteria: either stabilization of remission on the 16th week of therapy or decrease in consumption of alcohol on the 16th week of therapy, comparing to the same index before the investigational drug administration.

Among the additional objectives of the current study, the following can be marked out:

  • Assessment of effectiveness of the investigational drug in comparison to placebo in respect to the number of days of abstinence from alcohol starting from the start of therapy.
  • Assessment of effectiveness of the investigational drug in comparison to placebo in respect to the number of days during the follow-up period when the patient was drinking alcohol.
  • Assessment of effectiveness of the investigational drug in comparison to placebo against the scales of assessment of pathological attraction to alcohol
  • Assessment of effectiveness of the investigational drug in comparison to placebo against the scale of assessment of the quality of life
  • Assessment of safety of the investigational drug,

and others.

Previously conducted pre-clinical studies of the investigational nasal drops showed that its administration in animals (rats) who had a free choice between alcohol solution and water had led to prolonged decline in consumption of alcohol. Moreover, the distinctive feature of the investigational drug is its delayed and growing effect after the completion of administration.

The safety of these nasal drops has been previously investigated in the framework of the phase I study in 12 healthy volunteers.

Alcohol abuse is a major public health problem in Russia, which has one of the highest rates of alcohol consumption in the world. This is the major reason why many European and American pharmaceutical and biotechnology companies place trials in alcoholic patients and patients with alcohol abuse-related diseases in this region. The Sponsor of the current study is a Russian biotechnology company, and it is planned to screen 137 patients, 115 of which will be randomized, in the current study.