Effects of Substance P on Headache Induction in Healthy Individuals

Launched by DANISH HEADACHE CENTER · Oct 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a substance called Substance P, which is a molecule in our body that may play a role in causing headaches. The study aims to find out if giving Substance P to healthy adults can actually trigger a headache. It’s important to note that this trial is not yet recruiting participants, meaning it hasn’t started accepting volunteers yet.

To be eligible for the study, participants need to be between 18 and 65 years old and weigh between 50 and 100 kg. They should not have any history of significant headaches or certain medical conditions that could affect their safety, such as serious heart or lung issues. Participants will need to provide informed consent, which means they must understand the study and agree to take part in it. If you’re considering this trial in the future, you can expect to receive the Substance P infusion and be monitored for any headache symptoms that may occur.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 to 65 years of age upon entry into screening
• • A body weight of 50 to 100 kg
• • Provision of informed consent prior to initiation of any study-specific activities/procedures.
• Exclusion Criteria:
• • Any history of a primary or secondary headache disorder, except for infrequent episodic tensiontype headache
• • Any first-degree relatives with a history of a primary headache disorder, except for infrequent episodic tension-type headache
• • Any history of moderate to severe traumatic brain injury
• • Any history of cardiovascular disease, including cerebrovascular diseases
• • Any history of pulmonary disease
• • Any other clinically significant disorders, conditions, or diseases that might impact the safety of the subject or interfere with the study's evaluation, procedures, or completion, aside from those mentioned above. This includes any relevant medical history or evidence that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
• • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
• • Female subjects of childbearing potential with a positive pregnancy test during any study visit
• • Cardiovascular disease of any kind, including cerebrovascular diseases
• • Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
• • Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
• • Abnormalities on the electrocardiogram that, in the opinion of the site investigator, might pose a risk to the subject or impact the validity of the study results
• • Daily use of any medication other than contraceptives
• • Intake of any medication other than contraceptives within 48 hours of infusion start
• • Intake of caffeine, nicotine, and alcohol within 12 hours of infusion start
• • Headache of any intensity within 48 hours of infusion start