Peripheral Nociceptive Effects of Levcromakalim

Danish Headache Center

Status: Completed

Conditions: Levcromakalim; Pain

Treatments: Drug: Saline; Drug: Levcromakalim

Study type: Interventional

Funder types: Other

Identifiers

NCT03726242

Levcromakalim local injection

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Levcromakalim

Active Comparator group

Description:

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.

Treatment:

Drug: Saline

Drug: Levcromakalim

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Drug: Levcromakalim