search
Back to results

The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

Primary Purpose

Effect of Drug, Migraine Disorders

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lacosamide 50 MG Oral Tablet
Ibuprofen 400 mg
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Drug focused on measuring migraine, lacosamide, Egypt

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.

Sites / Locations

  • Kafr Elsheikh University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lacosamide group

control group

Arm Description

We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving 50 mg lacosamide Bid and Ibuprofen 200-400 mg only during migraine attacks.

We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving Ibuprofen 200-400 mg only during migraine attacks.

Outcomes

Primary Outcome Measures

serum CGRP level in lacosamide and control groups
Approximately 5 ml of venous blood was drawn from all participants and then centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20℃. The serum CGRP concentration was measured before starting treatment and after 3 months of treatment by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols.

Secondary Outcome Measures

efficacy of lacosamide
We compared the monthly migraine days change in both the lacosamide and control groups.

Full Information

First Posted
November 20, 2022
Last Updated
August 8, 2023
Sponsor
Kafrelsheikh University
search

1. Study Identification

Unique Protocol Identification Number
NCT05632133
Brief Title
The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
Official Title
a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
August 9, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

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
We assessed serum CGRP concentrations before and after treatment in two hundred episodic migraine patients according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years. We divided them into two groups first one received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and lacosamide 50 mg Bid for 3 months, and the other group received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks.
Detailed Description
Two hundred episodic migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 10-55 years with migraines. We divided them into two groups first one received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and lacosamide 50 mg Bid for 3 months, and the other group received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks. Our selected patients were naive and didn't receive any other prophylactic therapy for migraine. for each patient, the investigators did detailed history taking with stress on Age, sex, and criteria and type of migraine general examination full neurological examination: Full neurological examination Laboratory investigations include: Serum creatinine, Liver functions test to exclude any metabolic disorder. Approximately 5 ml of venous blood was drawn from all participants and centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20 ℃. The serum calcitonin gene-related peptide (CGRP) concentrations will be measured by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols. Serum level CGRP before starting treatment and after three months of treatment MRI T1, T2, and flair to exclude any secondary cause of headache.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
We assessed CGRP before and after treatment in two groups of episodic migraine patients; the first group (the lacosamide group) received Ibuprofen 200-400 mg as a treatment for acute migraine attacks and 50 mg lacosamide Bid for 3 months, and the second group (control group) received only Ibuprofen 200-400 mg as a treatment for acute migraine attacks
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lacosamide group
Arm Type
Experimental
Arm Description
We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving 50 mg lacosamide Bid and Ibuprofen 200-400 mg only during migraine attacks.
Arm Title
control group
Arm Type
Experimental
Arm Description
We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving Ibuprofen 200-400 mg only during migraine attacks.
Intervention Type
Drug
Intervention Name(s)
Lacosamide 50 MG Oral Tablet
Intervention Description
We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving 50 mg lacosamide Bid and Ibuprofen 200-400 mg only during migraine attacks.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Other Intervention Name(s)
control
Intervention Description
We assessed the serum level of CGRP before and after 3 months of treatment in 100 episodic migraine patients receiving Ibuprofen 200-400 mg only during migraine attacks.
Primary Outcome Measure Information:
Title
serum CGRP level in lacosamide and control groups
Description
Approximately 5 ml of venous blood was drawn from all participants and then centrifuged at 1000×g for 10 min. Serums were separated from the blood sample and stored at - 20℃. The serum CGRP concentration was measured before starting treatment and after 3 months of treatment by adapting the enzyme-linked immunosorbent assay (ELISA) kit following manufacturer protocols.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
efficacy of lacosamide
Description
We compared the monthly migraine days change in both the lacosamide and control groups.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed G Zeinhom, PHD
Phone
2001009606828
Email
mohamed_gomaa@med.kfs.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
sherihan R. ahmed, MSC
Phone
2001113432342
Email
sherihanrezk2016@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed G. Zeinhom, MD,PHD
Organizational Affiliation
neurology department kafr el-sheikh university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohamed G. Zeinhom, PHD
Organizational Affiliation
neurology department kafr el-sheikh university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
sherihan R. Ahmed, MSc
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed G. Zeinhom, PHD
Phone
2001009606828
Email
mohamed_gomaa@med.kfs.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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
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
15951714
Citation
Collins JJ, Baase CM, Sharda CE, Ozminkowski RJ, Nicholson S, Billotti GM, Turpin RS, Olson M, Berger ML. The assessment of chronic health conditions on work performance, absence, and total economic impact for employers. J Occup Environ Med. 2005 Jun;47(6):547-57. doi: 10.1097/01.jom.0000166864.58664.29.
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
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
result
PubMed Identifier
17955107
Citation
Landy S, DeRossett SE, Rapoport A, Rothrock J, Ames MH, McDonald SA, Burch SP. Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. MedGenMed. 2007 Jun 7;9(2):53.
Results Reference
result

Learn more about this trial

The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

We'll reach out to this number within 24 hrs