MigrainePhase 3NCT06361446
Zonisamide Versus Propranolol in Migraine
A Phase 3 study testing Zonisamide 50 MG and Propranolol in people with Migraine, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- Zonisamide 50 MG and Propranolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2024to 20 Apr 2025
- Phase
- Phase 3
- 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 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition,
- age from 10 to 55 years
Who cannot join
- Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
- patients with malignancy, collagen, liver, and renal diseases. patients with cardiovascular diseases like hypertension and diabetes patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafr Elsheikh University Hospital
Kafr ash Shaykh, 33511
mohamed G. Zeinhom, MD, 2001009606828, mohamed_gomaa@med.kfs.edu.eg
About this study
Official title: Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial
Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency
Read the detailed description
Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
- Conditions
- Migraine
- Being tested
- Zonisamide 50 MG, Propranolol
- Keywords
- zonisamide, propranolol, 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.
Zonisamide 50 MGDrug
Also called group A
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. all patients received zonisamide 100 mg daily and acetaminophen 500-1000 mg on migraine attack.
We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
PropranololDrug
Also called group B
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients received propranolol 160 mg daily and acetaminophen 500-1000 mg on migraine attack.
We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
| Study group | Role | What they receive |
|---|---|---|
| zonisamide and Acetaminophen arm | Experimental | The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive zonisamide 50 mg twice daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. Receives: Drug: Zonisamide 50 MG |
| Propranolol and Acetaminophen group | Experimental | The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive propranolol 160 mg once daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in migraine days per 28 days
The investigators will assess the change in migraine days per 28 days in each group.
Measured: 28 days
Secondary outcomes (4)
The total number of migraine days after three months of treatment
The investigators will assess the total migraine days after three months of regular use of 100 mg zonisamide twice daily and Acetaminophen 500-1000 mg in acute attack or propranolol (160 mg once daily) and Acetaminophen 500-1000 mg in acute attack alone.
Measured: 3 months
The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.
We will assess The percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency in each group
Measured: 3 months
HIT-6 score absolute change in each group after three months of treatment
The investigators assessed the absolute reduction in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)
Measured: 3 months
The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.
The safety of zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
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 posted11 Apr 2024
- Study start29 Mar 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed G. zeinhom, MD, Kafrelsheikh University
- Investigators
- mohamed G. Zeinhom, MD, Study director, neurology department kafr el-sheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361446
- Sponsor's protocol ID
- 023098816
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All the data supporting this research's findings may be available from the principal investigator Mohamed G. Zeinhom upon reasonable request.
Publications
Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002 Mar 26;58(6):885-94. doi: 10.1212/wnl.58.6.885.
PubMed 11914403Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.
PubMed 12807523Mushet GR, Miller D, Clements B, Pait G, Gutterman DL. Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine. Headache. 1996 Mar;36(3):137-43. doi: 10.1046/j.1526-4610.1996.3603137.x.
PubMed 8984084
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial
- ClinicalTrials.gov ID
- NCT06361446
- Acronym / sponsor ID
- 023098816
- Conditions
- Migraine
- Keywords
- zonisamide, propranolol, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 11 Apr 2024 (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.
Investigators aim to compare the effect of zonisamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency
Detailed description
Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive propranolol 160 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will assess The number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
| Arm | Type | Receives |
|---|---|---|
| zonisamide and Acetaminophen arm | Experimental | Drug: Zonisamide 50 MGThe arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive zonisamide 50 mg twice daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. |
| Propranolol and Acetaminophen group | Experimental | Drug: PropranololThe arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive propranolol 160 mg once daily and Acetaminophen 500-1000 mg only in acute migraine attacks for 3 months. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition,
- age from 10 to 55 years
Key exclusion criteria (2 listed)
- Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
- patients with malignancy, collagen, liver, and renal diseases. patients with cardiovascular diseases like hypertension and diabetes patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease
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 |
|---|---|---|
| Zonisamide 50 MGAlso: group AThe arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. all patients received zonisamide 100 mg daily and acetaminophen 500-1000 mg on migraine attack. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. | Drug | zonisamide and Acetaminophen arm |
| PropranololAlso: group BThe arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients received propranolol 160 mg daily and acetaminophen 500-1000 mg on migraine attack. We will assess The change in migraine days per 28 days, the number of migraine days after three months of treatment, and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. | Drug | Propranolol and Acetaminophen group |
Primary outcome
The change in migraine days per 28 days
Time frame: 28 days
The investigators will assess the change in migraine days per 28 days in each group.
4 secondary outcomes
The total number of migraine days after three months of treatment
Time frame: 3 months
The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.
Time frame: 3 months
HIT-6 score absolute change in each group after three months of treatment
Time frame: 3 months
The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Results publication: PubMed 11914403Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002 Mar 26;58(6):885-94. doi: 10.1212/wnl.58.6.885.
- Results publication: PubMed 12807523Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.
- Results publication: PubMed 8984084Mushet GR, Miller D, Clements B, Pait G, Gutterman DL. Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine. Headache. 1996 Mar;36(3):137-43. doi: 10.1046/j.1526-4610.1996.3603137.x.
- Individual participant dataSharing planned: No. All the data supporting this research's findings may be available from the principal investigator Mohamed G. Zeinhom upon reasonable request.
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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.
mohamed G. Zeinhom, MD study director
neurology department kafr el-sheikh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zonisamide 50 MG and Propranolol in people with Migraine, run by Kafrelsheikh 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 2 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 23 Apr 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 mohamed G. Zeinhom, MD (2001009606828, mohamed_gomaa@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in migraine days per 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06361446, which also lists 3 linked publications.
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 23 Apr 2024.