The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

NCT02485340 | Completed

• 1 other identifier: H-6-2014-071
• 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 a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Median headache score 0 hours after sumatriptan/placebo

  0 hours

• Median headache score 2 hours after sumatriptan/placebo

  2 hours

Study Arms (2)

Sumatriptan

ACTIVE COMPARATOR

headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg

Drug: 5-ISMN (isosorbide-5-mononitrate); Drug: Sumatriptan

Placebo

PLACEBO COMPARATOR

headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)

Drug: 5-ISMN (isosorbide-5-mononitrate); Drug: Placebo

Interventions

5-ISMN (isosorbide-5-mononitrate) DRUG

5-ISMN 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: Imdur

Placebo; Sumatriptan

Sumatriptan DRUG

5-ISMN 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 DRUG

5-ISMN is 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 - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy:
• healthy subjects of both sexes
• age 18-70 years
• weight 50-90 kg.
• Females were requested to use effective contraception.
• Migraine patients:
• Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes
• years
• 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, and intake of daily medication (except oral contraceptives).

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Emma Katrine Hansen

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

isosorbide-5-mononitrate; Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Emma Katrine Hansen, Doctor

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

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: June 4, 2015
• First Posted: June 30, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 22, 2016

Record last verified: 2016-01

Locations

DK (1)