MigrainePhase 2NCT03280342
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
A Phase 2 study testing IR-TPM (Topamax) and XR-TPM (Trokendi XR) in people with Migraine and Headache, run by University of Minnesota at 2 sites in United States.
Trial summary
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- IR-TPM (Topamax) and XR-TPM (Trokendi XR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2017to 13 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months
- Male or female, ages 18-65
- Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.
- If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.
- Native English speakers (due to speech and language analysis)
- Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.
Who cannot join
- Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.
- Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.
- A history of nephrolithiasis
- Have previously taken topiramate
- Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
Prism Research
Saint Paul, Minnesota, 55114
About this study
Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg
Read the 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.
- Being tested
- IR-TPM (Topamax), XR-TPM (Trokendi XR)
- Keywords
- Migraine, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR-TPM (Topamax)Drug
XR-TPM (Trokendi XR)
XR-TPM (Trokendi XR)Drug
XR-TPM (Trokendi XR)
| Study group | Role | What they receive |
|---|---|---|
| IR-TPM (Topamax) | Active comparator | IR-TPM (Topamax) Receives: Drug: IR-TPM (Topamax); Drug: XR-TPM (Trokendi XR) |
| XR-TPM (Trokendi XR) | Active comparator | Not described Receives: Drug: IR-TPM (Topamax); Drug: XR-TPM (Trokendi XR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 1) through Day 52
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline (Day 1) through Day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start30 Oct 2017
- Primary completion20 Aug 2018
- Study completion13 Sep 2018
Why it stopped: Sponsor terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a crossover, randomized, double blind design in conjunction with intensive pharmacokinetic sampling and multiple administrations of a neurocognitive test battery to directly compare the effects on cognition of IR-TPM to XR-TPM in adults with migraine. The dose will begin at 25mg and titrated in 25mg increments to reach target dose of 100mg.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Supernus Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Marino, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280342
- Sponsor's protocol ID
- FWA00000312-10
- Status last verified
- Oct 2019
- First submitted
- 1 Sep 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine
- ClinicalTrials.gov ID
- NCT03280342
- Acronym / sponsor ID
- FWA00000312-10
- Keywords
- Migraine, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Supernus Pharmaceuticals, Inc.
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a crossover, randomized, double blind design in conjunction with intensive pharmacokinetic sampling and multiple administrations of a neurocognitive test battery to directly compare the effects on cognition of IR-TPM to XR-TPM in adults with migraine. The dose will begin at 25mg and titrated in 25mg increments to reach target dose of 100mg.
| Arm | Type | Receives |
|---|---|---|
| IR-TPM (Topamax) | Active comparator | Drug: IR-TPM (Topamax), Drug: XR-TPM (Trokendi XR)IR-TPM (Topamax) |
| XR-TPM (Trokendi XR) | Active comparator | Drug: IR-TPM (Topamax), Drug: XR-TPM (Trokendi XR) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months
- Male or female, ages 18-65
- Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.
- If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.
- Native English speakers (due to speech and language analysis)
Key exclusion criteria (5 listed)
- Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.
- Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.
- A history of nephrolithiasis
- Have previously taken topiramate
- Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IR-TPM (Topamax)XR-TPM (Trokendi XR) | Drug | IR-TPM (Topamax), XR-TPM (Trokendi XR) |
| XR-TPM (Trokendi XR)XR-TPM (Trokendi XR) | Drug | IR-TPM (Topamax), XR-TPM (Trokendi XR) |
Primary outcome
Controlled Oral Word Association Test (COWA)-generative phonemic fluency
Time frame: Baseline (Day 1) through Day 52
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
4 secondary outcomes
Measures of semantic verbal fluency
Time frame: Baseline (Day 1) through Day 52
Digit Span Backward
Time frame: Baseline (Day 1) through Day 52
Digit Symbol Modalities Test (SDMT)
Time frame: Baseline (Day 1) through Day 52
Trails A & B
Time frame: Baseline (Day 1) through Day 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Marino, PhD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IR-TPM (Topamax) and XR-TPM (Trokendi XR) in people with Migraine and Headache, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled Oral Word Association Test (COWA)-generative phonemic fluency (time frame: Baseline (Day 1) through Day 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.