The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
a Randomized Pilot Study of Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients
Sponsor study identifier
interventional
200
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
August 9, 2023
Actual (reported)Study Completion
August 10, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)November 20, 2022
Actual (reported)November 30, 2022
Actual (reported)August 9, 2023
Actual (reported)August 10, 2023
Actual (reported)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
efficacy of lacosamide
3 months
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.
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.
Kafr Elsheikh University Hospital
Kafr ash Shaykh, 33511, Egypt
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.
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.
mohamed G. Zeinhom, MD,PHD
neurology department kafr el-sheikh university
mohamed G. Zeinhom, PHD
neurology department kafr el-sheikh university
sherihan R. Ahmed, MSc
neurology department kafr el-sheikh university
200 participants (actual enrollment reported by the registry).
First Submitted
November 20, 2022
First Posted
November 30, 2022
Zonisamide Versus Topiramate in Migraine
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Study Start
June 1, 2022
Actual (reported)Primary Completion
August 9, 2023
Actual (reported)Study Completion
August 10, 2023
Actual (reported)Last Updated
March 21, 2024
Record last verified: 2024-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: