Trials / Withdrawn
WithdrawnNCT03280342
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IR-TPM (Topamax) | XR-TPM (Trokendi XR) |
| DRUG | XR-TPM (Trokendi XR) | XR-TPM (Trokendi XR) |
Timeline
- Start date
- 2017-10-30
- Primary completion
- 2018-08-20
- Completion
- 2018-09-13
- First posted
- 2017-09-12
- Last updated
- 2019-11-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03280342. Inclusion in this directory is not an endorsement.