Current partner codePEPTIDESDE
NCT05632133·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

200

Locations

1

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Full 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 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.

Interventions

Treatment arms and agents.

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.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Nov 30, 2022

  2. Study start

    Jun 1, 2022

  3. Primary completion

    Aug 9, 2023

  4. Study completion

    Aug 10, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Mar 21, 2024

Outcomes

What the study measures.

Primary outcomes

serum CGRP level in lacosamide and control groups

Time frame · 3 months

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 outcomes

efficacy of lacosamide

Time frame · 3 months

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

Eligibility

Who can take part.

Minimum age
10 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

Publications

Results and literature.

PMID 11914403Lipton 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 15951714Collins 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 12807523Lipton 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 8984084Mushet 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 17955107Landy 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 38502425Elgamal 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.

Primary links

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