Peripheral Nociceptive Effects of Levcromakalim

Not Applicable

Completed

• Conditions: Levcromakalim; Pain
• Interventions: Drug: Levcromakalim; Drug: Saline

• Registration Number: NCT03726242
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2018-11-01
• Status Verified: 2019-01
• Primary Completion: 2019-01-20
• Study Completion: 2019-01-20
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Healthy volunteers of both sexes.
2. 18-60 years.
3. 50-100 kg.
4. Women of childbearing potential must use adequate contraception.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levcromakalim	Levcromakalim	To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0.
Levcromakalim	Saline	To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of 150 ug/ml levcromakalim after baseline time 0.
Saline	Saline	To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0.
Saline	Levcromakalim	To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection. To give 0,05 ml intradermal and 0.2 intramuscular of saline after baseline time 0.

Primary Outcome Measures

Name	Time	Method
Occurrence and change of Itching from baseline	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.
Occurrence and change of pain from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence and change of swelling from baseline	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.
Occurrence and change of redness from baseline	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.
Change of blood flow from baseline	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.
Change of skin temperature from baseline	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.

Trial Locations

Locations (1)

Danish headache center; 🇩🇰 Glostrup, Copenhagen, Denmark