MigrainePhase 4NCT06089356
Zolmitriptane as Prophylaxis for Chilhood Migraine
A Phase 4 study testing zolmitriptanee, topiramate and Valproate in people with Migraine, run by Tanta University at 1 site in Egypt.
Trial summary
zolmitriptane can be tried as prophylactic therapy of childhood migraine Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Migraine
- What is being tested?
- zolmitriptanee, topiramate and Valproate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Phase 4
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with migraine -
Who cannot join
- those who suffer from ischemic heart disease , or who have allergy to any of drugs used
- -
Trial locations and contacts
1 site in 1 country.
abeer salamah, ass prof contact
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Tanta, Kafrelsheikh
abeer salamah, lecturer, 0201009221243
About this study
Official title: Zolmitriptane as Prophylactic Therapy Childhood Migraine
zolmitriptane can be tried as prophylactic therapy of childhood migraine
Read the detailed description
90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate
- Conditions
- Migraine
- Being tested
- zolmitriptanee, topiramate, Valproate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolmitriptaneeDrug
Also called zolmitriptane tablet
zolmitriptane tablet daily
topiramateDrug
Also called topiramate tablet
topiramate once daily
ValproateDrug
Also called Valproate tablet
valproate once daily
| Study group | Role | What they receive |
|---|---|---|
| zolmitriptane | Active comparator | zolmitriptane tablet daily Receives: Drug: zolmitriptanee |
| topiramate | Active comparator | topiramate tablet daily Receives: Drug: topiramate |
| valproate | Active comparator | valproate once daily Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and severity of migraine attacks
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Abeer Salamah, ass prof, Principal investigator, kafrelsheikh university- egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089356
- Sponsor's protocol ID
- Migraine
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zolmitriptane as Prophylactic Therapy Childhood Migraine
- ClinicalTrials.gov ID
- NCT06089356
- Acronym / sponsor ID
- Migraine
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 18 Oct 2023 (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.
zolmitriptane can be tried as prophylactic therapy of childhood migraine
Detailed description
90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zolmitriptane | Active comparator | Drug: zolmitriptaneezolmitriptane tablet daily |
| topiramate | Active comparator | Drug: topiramatetopiramate tablet daily |
| valproate | Active comparator | Drug: Valproatevalproate once daily |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with migraine -
Key exclusion criteria (2 listed)
- those who suffer from ischemic heart disease , or who have allergy to any of drugs used
- -
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 |
|---|---|---|
| zolmitriptaneeAlso: zolmitriptane tabletzolmitriptane tablet daily | Drug | zolmitriptane |
| topiramateAlso: topiramate tablettopiramate once daily | Drug | topiramate |
| ValproateAlso: Valproate tabletvalproate once daily | Drug | valproate |
Primary outcome
number and severity of migraine attacks
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- 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.
abeer salamah, ass prof contact
Abeer Salamah, ass prof principal investigator
kafrelsheikh university- egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zolmitriptanee, topiramate and Valproate in people with Migraine, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact abeer salamah, ass prof (00201009221243, abeersalamah84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number and severity of migraine attacks (time frame: 6 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 18 Oct 2023.