The Effect of Sumatriptan and Placebo on CGRP Induced Headache

NCT03542357 | Completed DMC

• 1 other identifier: H-16000065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• AUC after infusion

  The investigators will assess the outcome measures 1 year after the beginning of the study

  1 year

Study Arms (2)

Sumatriptan

ACTIVE COMPARATOR

headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment

Drug: Calcitonin Gene Related Peptide; Drug: Sumatriptan 50 mg

Placebo

PLACEBO COMPARATOR

headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment

Drug: Calcitonin Gene Related Peptide; Drug: Placebo Oral Tablet

Interventions

Calcitonin Gene Related Peptide DRUG

CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Also known as: CGRP

Placebo; Sumatriptan

Sumatriptan 50 mg DRUG

CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Also known as: Imigran

Sumatriptan

Placebo Oral Tablet DRUG

CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy:
• Healthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception.
• Migraine patients:
• Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg.

You may not qualify if:

• Healthy:
• Any type of headache (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
• Migraine patients:
• Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Calcitonin Gene-Related Peptide; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: May 31, 2018
• Study Start: February 15, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)