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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01905748
Other study ID # 0040-09-EMC
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date December 31, 2020

Study information

Verified date October 2019
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies found relative high incidence of prothrombotic events in Migraine. The present study intends to assess the coagulation system and activation in patients with Migraine during steady state phase and at the beginning of attacks and after 72 hours. A control group of patients with another acute neurologic event like convulsions will be also studied. Patients will be at pediatric age and teenagers.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 15
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 20 Years
Eligibility Inclusion Criteria:

- Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.

Exclusion Criteria:

- Patients with other underlying neurological conditions of coagulation diseases

Study Design


Intervention

Other:
Laboratory tests
Laboratory tests: erythrocyte sedimentation rate (ESR), Blood Count, C reactive Protein, Protein C activity, Protein S activity,Antithrombin II activity, Coagulation Factor VIII and IX,Con Willebrand Factor, prothrombin time (PT), activated partial thromboplastin time (aPTT), Fibrinogen, D Dimer and Prothrombin Fragments F1 and F2.

Locations

Country Name City State
Israel Ha'Emek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with activation of the coagulation system. The further analysis will be performed in each patient: Pt, PTT, Platelets, Protein C, S, Antithrombin III, D Dimer, Factor VIII, Factor IX, Von Willebrand Factor and Prothrombin fragments I and II will be analyzed on day one of the crises, after 72 hours and in steady state. Two years, each patient will be studied at attack onset and after 72 hours.
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