MigraineNCT00777218
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
A study testing propranolol, zonisamide and topiramate in people with Migraine, run by University of South Alabama at 1 site in United States.
Trial summary
The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- propranolol, zonisamide and topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2011
- Phase
- Interventional
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
- subjects must between the age of 8-17 (inclusive)
Who cannot join
- diagnosis of tension-type headache or cluster headache
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Alabama Department of Neurology
Mobile, Alabama, 36693
About this study
The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population.
- Conditions
- Migraine
- Being tested
- propranolol, zonisamide, topiramate
- Keywords
- migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Also called Inderal
standard pediatric doses, based on body weight
zonisamideDrug
Also called Zonegran
standard pediatric dosages, based on body weight
topiramateDrug
Also called Topamax
standard pediatric dosages, based on body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: propranolol |
| 2 | Active comparator | Not described Receives: Drug: zonisamide |
| 3 | Active comparator | Not described Receives: Drug: topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Record if memory, repetition or recall was impaired by subject during specific time frame on medication.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionJul 2011
Why it stopped: Enrollment criteria was too challenging and Investigators changed Institutions
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.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. I. Lopez, MD, Principal investigator, University of South Alabama Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777218
- Sponsor's protocol ID
- 07-185
- Status last verified
- Dec 2020
- First submitted
- 21 Oct 2008
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine
- ClinicalTrials.gov ID
- NCT00777218
- Acronym / sponsor ID
- 07-185
- Conditions
- Migraine
- Keywords
- migraine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment criteria was too challenging and Investigators changed Institutions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Oct 2008 (estimated)
- 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.
The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: propranolol |
| 2 | Active comparator | Drug: zonisamide |
| 3 | Active comparator | Drug: topiramate |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
- subjects must between the age of 8-17 (inclusive)
Key exclusion criteria (1 listed)
- diagnosis of tension-type headache or cluster headache
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 |
|---|---|---|
| propranololAlso: Inderalstandard pediatric doses, based on body weight | Drug | 1 |
| zonisamideAlso: Zonegranstandard pediatric dosages, based on body weight | Drug | 2 |
| topiramateAlso: Topamaxstandard pediatric dosages, based on body weight | Drug | 3 |
Primary outcome
Record if memory, repetition or recall was impaired by subject during specific time frame on medication.
Time frame: 3 months
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 17 Dec 2020.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
J. I. Lopez, MD principal investigator
University of South Alabama Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propranolol, zonisamide and topiramate in people with Migraine, run by University of South Alabama at 1 site 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 2 inclusion and 1 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Record if memory, repetition or recall was impaired by subject during specific time frame on medication. (time frame: 3 months). 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 17 Dec 2020.