- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248931
Valproate Versus Topiramate in Migraine
Valproate Versus Topiramate in Migraine, a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: mohamed G. Zeinhom, MD
- Phone Number: 2001009606828
- Email: mohamed_gomaa@med.kfs.edu.eg
Study Contact Backup
- Name: sherihan R. ahmed, MD
- Phone Number: 2001113432342
- Email: sherihanrezk2016@gmail.com
Study Locations
-
-
-
Kafr Ash Shaykh, Egypt, 33155
- Recruiting
- Kafr Elsheikh University Hospital
-
Contact:
- mohamed G. Zeinhom, MD
- Phone Number: 2001009606828
- Email: mohamed_gomaa@med.kfs.edu.eg
-
Contact:
- sherihan R ahmed, MD
- Phone Number: 2001007481842
- Email: sherihanrezk2016@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years,
Exclusion Criteria:
- 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 major systemic diseases such as malignancy, collagen, liver, and renal diseases.
Patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level >126 mg/dl and/or a casual plasma glucose >200 mg/dl and/or HbA1C more than 6.5.
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 topiramate or valproate contraindications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: valproate arm
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria.
All patients will receive valproate 500-1000mg 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 valproate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
|
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria.
All patients will receive valproate 500-1000 mg 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.
Other Names:
|
Active Comparator: topiramate arm
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria.
All patients will receive topiramate 50-100mg 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 valproate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
|
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria.
All patients will receive topiramate 50-100 mg 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.
Time Frame: 3 months
|
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
|
3 months
|
HIT-6 score absolute reduction in each group after three months of treatment
Time Frame: 3 months
|
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)
|
3 months
|
The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.
Time Frame: 3 months
|
The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
|
3 months
|
The total number of migraine days after three months of treatment
Time Frame: 3 months
|
The investigators will assess the total migraine days after three months of regular use of 500-1000 mg valproate daily and Acetaminophen 500-1000 mg in acute attack or topiramate (50-100 mg daily) and Acetaminophen 500-1000 mg in acute attack alone.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: mohamed G. Zeinhom, MD,PHD, neurology department kafr el-sheikh university
Publications and helpful links
General 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.
- Lipton 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.
- Mushet 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
- Topiramate
Other Study ID Numbers
- 00000023988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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