OCT has successfully completed the first part of a complicated clinical trial on safety and efficacy confirmation of an investigational product in patients with multiple sclerosis. The first part of the trial was conducted in healthy volunteers. The screening and enrollment took 4 weeks to accomplish. The treatment and follow-up of the subjects comprised up to 3,1 months. The major goal of this phase was to assess safety and tolerability of the investigational medicinal product within one-dose administration. No SAEs were registered within the treatment period. The transition to the second part of the clinical study has been implemented. The second part will be conducted in patients. The investigational product is an oligopeptideimmunomodulating product for the treatment of multiple sclerosis.
Multiple sclerosis is an autoimmune disease related to the central nervous system field. The disease affects the spinal cord and the brain. Damage to the myelin sheath – which is a special protectivecoverage (insulation) surrounding nerve cells causes multiple sclerosis. The damage of the myelin sheath leads to nerve signals becoming slower or complete degeneration. The damage is usually caused by inflammation – when the individual’s immune cells start attacking their nervous system. This can happen in the spinal cord, brain, or the optic nerve. Since the attack severity and location can be different symptoms can vary. Multiple sclerosis is more likely to occur in women than in men and is more likely to be diagnosed in Caucasians rather than in other ethnicities.
In this trial, OCT has been responsible for all major activities, this is a full-service trial for our Company. In the first part, OCT has selected and initiated clinical trial phase I unit for the study conduct in healthy volunteers. Monitoring, reporting, project management have been implemented by OCT. This first part of the trial has now given an impulse for the beginning of the second part, which will be conducted in several neurology clinical sites in patients with multiple sclerosis. OCT is also responsible for all services – including sites initiation, clinical monitoring, project management, safety monitoring, final report writing, etc. This is already not the first trial conducted with thisClient.
OCT has had experience in this therapeutic indication and in multiple sclerosis studies, as well, including studies not only in the Russian Federation but also in other OCT countries of operation like Ukraine. OCT will be glad to make feasibility assessment for your clinical trial in the region and assist you in conducting a study.