A Phase 2 interventional study of IR-TPM (Topamax) and XR-TPM (Trokendi XR) in Migraine and Headache, sponsored by University of Minnesota. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg
The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely Trokendi XR®, regimen on cognition in adults with migraine.
The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.
Exclusion Criteria:
IR-TPM (Topamax)
Drug: IR-TPM (Topamax) · Drug: XR-TPM (Trokendi XR)
Drug: IR-TPM (Topamax) · Drug: XR-TPM (Trokendi XR)
XR-TPM (Trokendi XR)
XR-TPM (Trokendi XR)
Controlled Oral Word Association Test (COWA)-generative phonemic fluency
The primary outcome measure is the Controlled Oral Word Association (COWA: phonemic generative fluency). COWA was chosen as the primary endpoint since in previous studies of drug-induced cognitive impairment, this measure was sensitive to the effects of topiramate (Meador et al, 2003; Marino et al, 2012; Marino et al, 2015). The primary endpoint is a change in the COWA score from baseline to each post-dose assessment
Time frame: Baseline (Day 1) through Day 52
Measures of semantic verbal fluency
Change in scores from individual baseline to each post-dose assessment on measures of semantic verbal fluency (e.g., Animals)
Time frame: Baseline (Day 1) through Day 52
Digit Span Backward
Change in scores from individual baseline to each post-dose assessment on measures of working memory (i.e., Digit Span Backward)
Time frame: Baseline (Day 1) through Day 52
Digit Symbol Modalities Test (SDMT)
Change in scores from individual baseline to each post-dose assessment on measure of psychomotor speed
Time frame: Baseline (Day 1) through Day 52
Trails A & B
Change in scores from individual baseline to each post-dose assessment on measures of executive function
Time frame: Baseline (Day 1) through Day 52
Plan to share: No
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University of Minnesota