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

Migraine Disorders Clinical Trial

Official title:

a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632133
• Other study ID #: 2398816
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: March 2024
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 1. detailed history taking with stress on Age, sex, and criteria and type of migraine 2. general examination 3. full neurological examination: Full neurological examination 4. Laboratory investigations include: Serum creatinine, Liver functions test to exclude any metabolic disorder. 5. 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. 6. Serum level CGRP before starting treatment and after three months of treatment 7. MRI T1, T2, and flair to exclude any secondary cause of headache.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 10, 2023
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effect of Drug
• Migraine Disorders

Intervention

Drug:
• Lacosamide 50 MG Oral Tablet
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.
• Ibuprofen 400 mg
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.

Locations

Country	Name	City	State
Egypt	Kafr Elsheikh University Hospital	Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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 — View 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, an — View 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.1468-2982.2003.005 — View 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. — View 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.1526-461 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	efficacy of lacosamide	We compared the monthly migraine days change in both the lacosamide and control groups.	3 months