Lacosamide Versus Topiramate in Migraine

NCT06243692 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 0000023988
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aim to compare the effect of lacosamide versus topiramate 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.

Conditions

Migraine Disorders

Keywords

lacosamide; topiramate; migraine

Outcome Measures

Primary Outcomes (1)

• The change in migraine days per 28 days

  The investigators will assess the change in migraine days per 28 days in each group.

  28 days

Secondary Outcomes (4)

• The total number of migraine days after three months of treatment

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (2)

lacosamide arm

ACTIVE COMPARATOR

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive Lacosamide 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.

Drug: Lacosamide 50 MG

Topiramate arm

ACTIVE COMPARATOR

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive topiramate 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.

Drug: Topiramate 50Mg Tab

Interventions

Lacosamide 50 MG DRUG

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. 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 treatment 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

lacosamide arm

Topiramate 50Mg Tab DRUG

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. 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 treatment 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: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 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 lacosamide contraindications

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

RECRUITING

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, Khalil MFE, Almoataz M, Youssif TYO, Daabis AMA, Refat HM, Ebied AAMK, Georgy SS, Akl AZO, Ismaiel M, Ahmed SI, Eissa HF, Ibrahem AIDM, Hassan AM, Elshafei M, Egila AAE, Ahmed SR. Lacosamide versus topiramate in episodic migraine: a randomized controlled double-blinded trial. Ther Adv Neurol Disord. 2025 Dec 9;18:17562864251396529. doi: 10.1177/17562864251396529. eCollection 2025.

  PMID: 41384236 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lacosamide; Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• mohamed G. Zeinhom, MD

  neurology department kafr el-sheikh university

  STUDY DIRECTOR

Central Study Contacts

mohamed G. Zeinhom, MD

CONTACT

2001009606828; mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342; sherihanrezk2016@gmail.com

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 lacosamide 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 lacosamide, and Drug B included propranolol. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B. Both groups received open-label 500-1000mg acetaminophen during acute attack.
• 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 29, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 25, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)