CHALLENGES & OPPORTUNITIES WITH CLINICAL TRIALS FOREPILEPSY
CHALLENGES & OPPORTUNITIES WITH CLINICAL TRIALS FOR EPILEPSY
Epilepsy is characterized by recurrent, unprovoked seizures as a result of a genetic or an acquired brain injury, such as trauma or stroke. Epilepsy is not a single condition but a group of different sets of epilepsies; all of them share a tendency for seizures that gets started in the brain.
COMMON CAUSES:
Children: genetic causes, birth injury.
Adults: trauma.
Old age: stroke, tumors and CNS degenerative changes.
PREVALANCE:
Epilepsy is a group of conditions with a wide range of seizure types, causes & associated symptoms. Around the globe, epilepsy is not considered as a rare disease as it affects more than 2 lakh individuals. According to Epilepsy foundation, of the 65million people worldwide suffering with epilepsy, a significant population has a rare form of the disease, which initially affects children & can shorten their life span.
CONDUCTING EPILEPSY CLINICAL TRIALS: CHALLENGES & SOLUTIONS
A major barrier to ASD development is the greater difficulty of conducting randomized placebo-controlled trials, a mainstay for demonstrating efficacy. Availability of numerous ASDs, especially in developed countries, makes enrollment in trial is difficult, since a patient may get a placebo. Recruitment in monotherapy trials, in which a patient get only placebo, is even more difficult.
Artificial intelligence & machine learning reviews EHRs which helps to identify patients with rare types of epilepsies for possible trial inclusion. Patients can also be referred to a natural history study or a clinical trial ready network.
Another challenge with epilepsy clinical trials concerns traditional outcomes which may not be clinically meaningful. Trials may be improved by incorporating multidimensional, relevant outcome measures that reflect patient experience, including patient centered outcomes such as socio-economic impacts, risk of serious injury and death. It is critical to engage patients and families when considering meaningful outcome measures.
These and other difficulties have led to recommendations for alternative trial designs. Additionally, time-to-event designs, in which patients must exit the trial after a predetermined number of seizures, can be employed.
CONCLUSION:
Treatment of epilepsy seems to be a sea of contradictions. Progress has been made on many fronts, including community services, education access to care and funding for new therapies. Yet people with epilepsy are at higher risk for depression, suicide in many countries. And while new and improved ASDs have been developed, 30% of patients haven’t achieved freedom from seizures. Etiologies of epilepsy, particularly rare forms of a disease, have grown exponentially, providing a key to unlock the development of better and more targeted therapies. But misperceptions about the difficulties and shortcomings of ASD development persist, declines the therapeutic progress.
REFERENCES:
• https://clinicaltrials.gov/ct2/results?cond=Epilepsy&term=&cntry=&state=&city=& dist.
• https://www.tandfonline.com/doi/abs/10.1080/17512433.2017.1356720
• https://www.sciencedirect.com/science/article/abs/pii/S1474442218300383
T. Jahnavi,
B.Pharmacy IV year,
Student at Clinosol,
Student ID – (CSRPL_INT_ONL_WKD_069/0421).
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