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Safety and Efficacy of Lacosamide in Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lacosamide 50 MG
Acetaminophen 500-1000
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring lacosamide, migraine

Eligibility Criteria

10 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 diseases, liver diseases, 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, patients who received prophylactic treatment for migraine, patients with any contraindications to lacosamide and/or acetaminophen.

Sites / Locations

  • Kafr Elsheikh University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lacosamide and Acetaminophen arm

Acetaminophen group

Arm Description

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess the absolute change in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.

The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess the absolute change in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.

Outcomes

Primary Outcome Measures

absolute change in the score of monthly migraine days after 3months of treatment
We will assess the absolute change in monthly migraine days after 3 months of regular use of 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, or lacosamide (100 mg Bid) and Ibuprofen 200-400mg in acute attack, or Acetaminophen 500-1000 mg in acute attack alone.
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. After three months of regular use of 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, or lacosamide (100 mg Bid) and Ibuprofen 200-400mg in acute attack, or Acetaminophen 500-1000 mg in acute attack alone
The percentage of responders to acute treatment
We will assess the percentage of responders to acute treatment that was identified when patients achieved pain freedom within 2 hours in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks.
The percentage of patients who achieved a low MIGSEV scale (grade 1)
the percentage of patients who achieved low MIGSEV scale (grade 1) after 3 months of treatment.

Secondary Outcome Measures

safety of lacosamide by using a complication Survey
Assessing all possible side effects related to lacosamide using a complication Survey

Full Information

First Posted
April 30, 2023
Last Updated
September 15, 2023
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT05851781
Brief Title
Safety and Efficacy of Lacosamide in Migraine
Official Title
The Safety and Efficacy of Lacosamide in Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators aim to study the effect of lacosamide as a potential treatment for 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. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after three months of treatment. , in patients diagnosed with migraines based on the International Classification of Headache Disorders (ICHD) 3rd edition.
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 the results of the migraine severity scale (MIGSEV) and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive Acetaminophen 500-1000 mg in acute attack alone for at least three months. Investigators will assess the change in migraine monthly days and the results of the migraine severity scale (MIGSEV) test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
lacosamide, migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
We will assess 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. And the percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lacosamide and Acetaminophen arm
Arm Type
Experimental
Arm Description
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess the absolute change in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.
Arm Title
Acetaminophen group
Arm Type
Experimental
Arm Description
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess the absolute change in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.
Intervention Type
Drug
Intervention Name(s)
Lacosamide 50 MG
Intervention Description
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess 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. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen 500-1000
Intervention Description
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess 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. The percentage of responders to acute treatment was identified when patients achieved pain freedom within 2 h in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks (12). The fourth factor was the percentage of patients who achieved a low MIGSEV scale (grade 1) after 3 months of treatment.
Primary Outcome Measure Information:
Title
absolute change in the score of monthly migraine days after 3months of treatment
Description
We will assess the absolute change in monthly migraine days after 3 months of regular use of 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, or lacosamide (100 mg Bid) and Ibuprofen 200-400mg in acute attack, or Acetaminophen 500-1000 mg in acute attack alone.
Time Frame
3 months
Title
The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.
Description
We will assess The percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. After three months of regular use of 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, or lacosamide (100 mg Bid) and Ibuprofen 200-400mg in acute attack, or Acetaminophen 500-1000 mg in acute attack alone
Time Frame
3 months
Title
The percentage of responders to acute treatment
Description
We will assess the percentage of responders to acute treatment that was identified when patients achieved pain freedom within 2 hours in ≥ 4 of 5 attacks, while insufficient responders achieved pain freedom in ≤ 3 of 5 attacks.
Time Frame
3 months
Title
The percentage of patients who achieved a low MIGSEV scale (grade 1)
Description
the percentage of patients who achieved low MIGSEV scale (grade 1) after 3 months of treatment.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
safety of lacosamide by using a complication Survey
Description
Assessing all possible side effects related to lacosamide using a complication Survey
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 diseases, liver diseases, 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, patients who received prophylactic treatment for migraine, patients with any contraindications to lacosamide and/or acetaminophen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed G. Zeinhom, MD
Organizational Affiliation
neurology department kafr el-sheikh university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
sherihan R. Ahmed, MD
Organizational Affiliation
neurology department kafr el-sheikh university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafr Elsheikh University Hospital
City
Kafr Ash Shaykh
ZIP/Postal Code
33511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All the data supporting this research's findings may be available from the principal investigator Mohamed G. Zeinhom upon reasonable request.
Citations:
PubMed Identifier
8984084
Citation
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.
Results Reference
background
PubMed Identifier
11914403
Citation
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.
Results Reference
result
PubMed Identifier
12807523
Citation
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.
Results Reference
result

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Safety and Efficacy of Lacosamide in Migraine

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