Success story in Neurology

Therapeutic area: Epilepsy

In the most of developed countries the number of patients with epilepsy is 0.8 -1.2% of the population. The range of epilepsy in Russia is 5-8 persons per thousand.
A partial seizure is an episode of abnormal electrical activity that is the product of a lesion in some part of the cerebral cortex.  These lesions may have been present since birth or earlier (congenital), or they may develop following head trauma, infections, stroke, and certain other conditions.  Partial seizures can be further characterized as:
- simple (not affecting awareness and memory)
- сomplex (affecting awareness and memory of events before, during, and immediately after the seizure, and affecting behavior).
Partial seizures commonly evolve. 

Study sponsored by: USA pharmaceutical company

Study description: Study to Evaluate the Efficacy and Safety of IMP Extended-Release as Adjunctive Therapy in Subjects with Refractory Partial Seizures due to Epilepsy on up to three Concomitant Antiepileptic Medications

Study design: Phase III, Multicenter, double-blind, randomized, placebo-controlled, three-arm, parallel group study.

Number of involved countries: 8 (USA, Bulgaria, Canada, Croatia, Mexico, Poland, Romania, Russian Federation)

Planned randomized  patients for  involved countries: 360 patients

Client goal: to immediately accelerate enrollment, recruiting 60 additional patients during one month

Challenge: complex protocol

Number of sites in Russia: 18 sites.

 

Results: The recruitment program exceeded the sponsor’s expectations. Enrollment was completed sooner than expected.