Valproate Versus Topiramate in Migraine

NCT06248931 | Completed Phase 3 FDA Drug

• 1 other identifier: 00000023988
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aim to compare the effect of valproate versus topiramate in migraine by assessing the 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.

Conditions

Migraine Disorders

Keywords

topiramate; valproate; migraine

Outcome Measures

Primary Outcomes (2)

• The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency.

  We will assess The percentage of patients who achieved ≥ 50% change in the monthly headache days frequency compared to the baseline frequency in each group

  3 months

• The number of patients who discontinued treatment due to treatment-emergent adverse events.

  The investigator will assess The number of patients who discontinued treatment due to treatment-emergent adverse events in each group after 3 months of treatment

  90 days

Secondary Outcomes (5)

• The severity of migraine attack on VAS score after three months of treatment

  3 months

• HIT-6 score change in each group after three months of treatment

  3 months

• Treatment safety was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.

  3 months

• The monthly migraine days per month

  30 days

• The duration of migraine attack in hours after three months of treatment

  3 months

Study Arms (2)

valproate arm

ACTIVE COMPARATOR

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.

Drug: Valproic acid

topiramate arm

ACTIVE COMPARATOR

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.

Drug: Topiramate 50 MG

Interventions

Valproic acid DRUG

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 valproate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Also known as: group A

valproate arm

Topiramate 50 MG DRUG

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 topiramate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Also known as: group B

topiramate arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33155, Egypt

Location

Related Publications (4)

• 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.

  PMID: 11914403 RESULT

• 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.

  PMID: 12807523 RESULT

• 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.

  PMID: 8984084 RESULT

• Zeinhom MG, Elsayed Khalil MF, Omar Youssif TY, Ali Daabis AM, Almoataz M, Refat HM, Mohamed Kamal Ebied AA, Atiaa Mohamed DM, Ismaiel M, Mohamed Kamel IF, Elballat AIE, Omar Akl AZ, Ahmed SR. Efficacy and tolerability of valproate versus topiramate in migraine prevention, a randomized controlled multi-center trial. J Clin Neurosci. 2025 May;135:111156. doi: 10.1016/j.jocn.2025.111156. Epub 2025 Feb 27.

  PMID: 40020561 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Valproic Acid; Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• mohamed G. Zeinhom, MD,PHD

  neurology department kafr el-sheikh university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either valproate or topiramate from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included topiramate, and Drug B included valproate. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: 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 (14). HIT-6 score reduction in each group after three months of treatment. 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.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: May 1, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)