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Headache Disorders, Primary clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT05760625 Enrolling by invitation - Clinical trials for Primary Headache Disorder

Gender Differences and Features of the Clinical Course of Primary Headaches

Start date: December 10, 2020
Phase:
Study type: Observational [Patient Registry]

The pathophysiological mechanisms that underlie primary headache disorders, such as migraine and cluster headache (CH), are complex and not yet fully clarified. While there is today little doubt that activation of the trigeminovascular system (TGVS) is responsible for the headache pain, the primary mechanisms, probably centrally mediated, leading to its activation and the generation of pain are still largely obscure. The trigeminal system is supposed to play a central role not only in migraine but also in cluster headache pathology. In vitro studies have demonstrated the expression of BDNF in trigeminal ganglion neurons. BDNF release is induced by trigeminal stimulation and nociceptive inputs. BDNF is a member of the neurotrophin family and has been recognized as an important modulator of nociceptive pathways. Interestingly, BDNF is co-expressed with CGRP in trigeminal ganglion neurons. CGRP is one of the key molecules in migraine and cluster headache pathogenesis. BDNF is an important marker of neuronal plasticity. It has also been associated with pain processing. Increased BDNF levels are observed in chronic pain syndromes. In order to understand the role of BDNF associated with other factors such as gender on headache attacks we aimed to determine whether migraine and cluster headache is correlated with brain derived neurotrophic factor (BDNF) level, gender and age.