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Completed

NCT Number: NCT03726242

Peripheral Nociceptive Effects of Levcromakalim

Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated:

1. Prevalence and intensity of pain 2. Prevalence and intensity of itching 3. Occurrence and intensity of local redness and swelling 4. Occurrence and intensity of local changes in skin temperature and blood flow

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Key information

Conditions

Pain Levcromakalim Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers of both sexes.
  • 18-60 years.
  • 50-100 kg.
  • Women of childbearing potential must use adequate contraception.

Exclusion criteria

  • A history of serious somatic disease
  • Migraine or any other type of headache (except episodic tension-type headache less than once a month)
  • Daily intake of any medication except contraceptives

Treatment and study plan

Levcromakalim

Drug

To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Saline

Drug

To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Primary outcomes

  1. Occurrence and change of pain from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection

    Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used.

    The outcome measure is pain and the unit that will be used to measure the pain is NRS.

  2. Occurrence and change of Itching from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection

    Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used.

    The outcome measure is itching and the unit that will be used to measure the itching is NRS.

Secondary outcomes

  1. Occurrence and change of redness from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.

    Occurrence and change of redness after levcromakalim injektion compared to placebo. The areal of the redness will be measured.

    The outcome measure is redness and the unit that will be used to measure the redness is areal cm^2.

  2. Occurrence and change of swelling from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.

    Occurrence and change of swelling after levcromakalim injektion compared to placebo. The areal of the swelling will be measured.

    The outcome measure is swelling and the unit that will be used to measure the swelling is areal cm^2.

  3. Change of blood flow from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.

    Change of blodflow after levcromakalim injektion compared to placebo. The intensity of the blodd flow will be measured by laser speckle The outcome measure is change of blood flow and the laser speckle will be used to measure the blood flow.

  4. Change of skin temperature from baseline

    Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.

    Change of skin temperature after levcromakalim injektion compared to placebo. The temperature will be measured by thermovision camera.

    The outcome measure is the change of skin temperature and the thermovision camera will be used to measure skin temperature.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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