Printable Handouts

PDF

Navigable Slide Index

1. Introduction
2. Conflict of interest statement and disclaimer
3. Antiseizure drugs versus antiepileptic drugs
4. The discovery of antiseizure drugs
5. Potassium bromide
6. Phenobarbital
7. Phenobarbital structure
8. Phenytoin
9. Equipment for testing electroshock thresholds
10. The discovery of phenytoin
11. Early concepts in discovery of antiseizure drugs
12. Experimental seizures in mice
13. Disadvantages of MES and ScPTZ
14. The challenge of newer tests
15. ERA 1938 - 1960 (1)
16. ERA 1938 - 1960 (2)
17. ERA 1961 - 1974
18. Major antiseizure drugs in use pre-1990
19. Anticonvulsant screening program (APS)
20. ASP receipt of test substance
21. Does the ASP find new drugs?
22. Discovery of antiseizure drugs
23. New strategies for rational AED development
24. New antiseizure drugs since 1990
25. The clinical development of antiseizure drugs
26. Ideal product profile
27. Edward Sieveking citation
28. Clinical study drug treated group
29. Clinical study placebo treatment
30. Topics not discussed here
31. Investigational new drug (IND)
32. Drug product flow
33. Phase I
34. Phase I studies
35. Typical phase I studies
36. Two fundamentals of clinical pharmacology
37. Aims of phase I studies
38. Issues in determining tolerability and toxicity
39. Evaluating pharmacodynamic efficacy in phase I
40. Determining the pharmacokinetic profile (ADME)
41. Summary of phase I program
42. Phase II: proof of principle
43. Shortcuts don't provide reliable preliminary efficacy
44. Preclinical predictions
45. Choosing compounds for clinical development
46. The patients in clinical trials: seizure type
47. The first concept in epilepsy clinical trials design
48. Type of seizure
49. Two kinds of seizures
50. Clinical trials of partial seizures
51. The patients in clinical trials: seizure frequency
52. Seizure frequency of patients: guidelines
53. Concomitant medications and drug interactions
54. Drug interactions: defined before clinical trial
55. The doses to be tested
56. The doses: guidelines
57. Maximum tolerated dose (MTD) in humans (1)
58. Maximum tolerated dose (MTD) in humans (2)
59. Study designs
60. Retigabine (Ezogabine)
61. Study 202 design (phase IIA)
62. Conclusions from retigabine phase IIA study
63. Retigabine phase IIB study
64. Retigabine study 205 design (1)
65. Retigabine study 205 design (2)
66. Study 205: reduction in partial seizure frequency
67. Study 205: responder rate
68. Study 205: treatment emergent adverse events
69. Study 205: discontinuation due to adverse events
70. Study 205: conclusions
71. Study 212
72. Phase III
73. Retigabine phase III
74. Primary efficacy endpoints at phase III
75. Lecture summary (1)
76. Lecture summary (2)
77. Lecture summary (3)
78. References

Topics Covered

• Seizures and epilepsy
• Drugs for the symptomatic treatment of seizures
• Finding new Anti-Seizure Drugs is a combination of serendipity, screening and rational approaches
• Drug Development
• Preclinical studies
• Controlled Clinical Trials are needed to prove that an anti-seizure drug is effective

Links

Series:

• Drug Discovery and Development in the Neurosciences
• Epilepsy and Seizures

Categories:

• Neuroscience
• Pharmaceutical Sciences

Therapeutic Areas:

• Neurology

Talk Citation

Publication History

• Published on March 28, 2013

Financial Disclosures

• Dr. Roger Porter, Consultant: Epilepsy Therapy Project, NeuroPace, Upsher-Smith, Zalicus, Medivation, SK Pharma, Civitas.