NCT01700387 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bootsma HP, Aldenkamp AP, Diepman L, Hulsman J, Lambrechts D, Leenen L, Majoie M, Schellekens A, de Krom M
The Effect of Antiepileptic Drugs on Cognition: Patient Perceived Cognitive Problems of Topiramate versus Levetiracetam in Clinical Practice. Epile
Kim SY, Lee HW, Jung DK, Suh CK, Park SP
Cognitive Effects of Low-dose Topiramate Compared with Oxcarbazepine in Epilepsy Patients. J Clin Neurol. 2006 Jun;2(2):126-33. doi: 10.3988/jcn.2006.2.2.126. Epub 2006 Jun 20.
Meador KJ, Loring DW, Vahle VJ, Ray PG, Werz MA, Fessler AJ, Ogrocki P, Schoenberg MR, Miller JM, Kustra RP
Cognitive and behavioral effects of lamotrigine and topiramate in healthy volunteers. Neurology. 2005 Jun 28;64(12):2108-14.

A Randomized, Pilot Study to Evaluate the Tolerability of OnabotulinumtoxinA Plus Topiramate vs. OnabotulinumtoxinA Plus Placebo and Long Term Effect of Treatment on Cognitive Efficiency and Continuation of Care

Details for clinical trial NCT01700387

Clinical trial NCT01700387 - References