OCT has launched the second part of a two-stage clinical research on safety and efficacy confirmation of an oligopeptide immunomodulating drug in patients with multiple sclerosis.
The 20-months study, which started autumn 2012, consists of the two stages. The first part of the trial was conducted in healthy volunteers during 4 months. Screening and enrollment took 4 weeks to accomplish. The main goal of this phase was to assess safety and tolerability of the investigational medicinal product within one-dose administration. The first phase, which was completed December 2012, showed positive results – no Serious Adverse Events were registered within the treatment period.
The second phase of the study will be conducted in patients with relapsing and remitting and secondary-progressive forms of multiple sclerosis to access safety and tolerability of the investigational medicinal product within multiple-dose administration. The second phase will involve 20 patients divided in two cohorts to receive treatment weekly in increasing dosage during 5 weeks. The planned follow-up period is 3 months.
After the successful completion of the first stage, the study has currently proceeded to its second phase. Two sites have already been opened and they are in the process of active enrollment. As a whole, 4 to 8 sites are planned to be opened in Russia, depending on patients recruitment rate.
The described trial is complex and significant by its nature, considering lack of a reference drug. Results, obtained within the current clinical trial, will be used to plan the future studies of the investigational drug safety and efficacy.
As a full-service contract research organization, OCT was addressed by the Sponsor to assist in conducting the current clinical trial starting with consulting, feasibility assessment and medical documentation preparation and ending with a final report provision. OCT was also responsible for selection of the phase I unit for the study conduct in healthy volunteers, as well as for clinical and safety monitoring, project management and reporting.
This is not the first study on multiple sclerosis conducted by the OCT team: we have extensive experience of such clinical trials not only in Russia, but in other countries of OCT presence.
With a complete team of our skillful clinical research associates and project managers and constant quality control from the inside of the company, we always feel secure about the level of services we provide.