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Effect of DrugPhase 3NCT05632133

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

A Phase 3 study testing Lacosamide 50 MG Oral Tablet and Ibuprofen 400 mg in people with Effect of Drug and Migraine Disorders, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 55 years
Conditions the study is for
Effect of Drug, Migraine Disorders
What is being tested?
Lacosamide 50 MG Oral Tablet and Ibuprofen 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jun 2022to 10 Aug 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Naive migraine patients according to the International Classification of Headache Disorders 3rd edition aged 10-55 years,

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kafr Elsheikh University Hospital

    Kafr ash Shaykh, 33511

Other trials in Egypt

About this study

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

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.

Read the 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.
Being tested
Lacosamide 50 MG Oral Tablet, Ibuprofen 400 mg
Keywords
migraine, lacosamide, Egypt
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lacosamide 50 MG Oral TabletDrug

    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 mgDrug

    Also called control

    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.

Study groups in NCT05632133
Study groupRoleWhat they receive
lacosamide groupExperimentalWe 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.
Receives: Drug: Lacosamide 50 MG Oral Tablet; Drug: Ibuprofen 400 mg
control groupExperimentalWe 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.
Receives: Drug: Ibuprofen 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (1)

  1. efficacy of lacosamide

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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start1 Jun 2022
  3. Primary completion9 Aug 2023
  4. Study completion10 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632133
Sponsor's protocol ID
2398816
Status last verified
Mar 2024
First submitted
20 Nov 2022
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: All the data supporting this research's findings may be available from the principal investigator Mohamed G. Zeinhom upon reasonable request.

Publications

  • 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.

    PubMed 11914403

  • 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.

    PubMed 15951714

  • 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.

    PubMed 12807523

  • 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.

    PubMed 8984084

  • 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.

    PubMed 17955107

  • 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.

    PubMed 38502425

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lacosamide 50 MG Oral Tablet and Ibuprofen 400 mg in people with Effect of Drug and Migraine Disorders, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum CGRP level in lacosamide and control groups (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05632133, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.

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