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

NCT05632133 | Completed Phase 3

• 1 other identifier: 2398816
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Effect of Drug; Migraine Disorders

Keywords

migraine; lacosamide; Egypt

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• efficacy of lacosamide

  3 months

Study Arms (2)

lacosamide group

EXPERIMENTAL

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.

Drug: Lacosamide 50 MG Oral Tablet; Drug: Ibuprofen 400 mg

control group

EXPERIMENTAL

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.

Drug: Ibuprofen 400 mg

Interventions

Lacosamide 50 MG Oral Tablet DRUG

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.

lacosamide group

Ibuprofen 400 mg DRUG

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.

Also known as: control

control group; lacosamide group

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 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

Location

Related Publications (6)

• 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

• 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.

  PMID: 15951714 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

• 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.

  PMID: 17955107 RESULT

• Elgamal S, Ahmed SR, Nahas MM, Hendawy SR, Elshafei O, Zeinhom MG. The effect of lacosamide on calcitonin gene-related peptide serum level in episodic migraine patients: a randomized, controlled trial. Acta Neurol Belg. 2024 Jun;124(3):965-972. doi: 10.1007/s13760-024-02499-9. Epub 2024 Mar 19.

  PMID: 38502425 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Lacosamide; Tablets; Ibuprofen

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; Dosage Forms; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic

Study Officials

• mohamed G. Zeinhom, MD,PHD

  neurology department kafr el-sheikh university

  STUDY DIRECTOR

• mohamed G. Zeinhom, PHD

  neurology department kafr el-sheikh university

  PRINCIPAL INVESTIGATOR

• sherihan R. Ahmed, MSc

  neurology department kafr el-sheikh university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prinicipal investigator

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: June 1, 2022
• Primary Completion: August 9, 2023
• Study Completion: August 10, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

EG (1)