Peripheral Nociceptive Effects of Levcromakalim

• Sponsor: Danish Headache Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03726242
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain; Levcromakalim	Drug: Levcromakalim; Drug: Saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Parallel, randomized placebo controlled and crossover studyParallel, randomized placebo controlled and crossover study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Study of Local Physiological Effects Following Intradermal and Intramuscular Injection of Levcromacalim
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Jan 20, 2019
• Actual Study Completion Date: Jan 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Levcromakalim; To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.; Drug: Saline; To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
Placebo Comparator: 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.	Drug: Levcromakalim; To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.; Drug: Saline; To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danish headache center	Glostrup	Copenhagen	Denmark	2600

Sponsors and Collaborators

• Danish Headache Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student, Principal investigator, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT03726242
• Other Study ID Numbers: Levcromakalim local injection
• First Posted: Oct 31, 2018
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cromakalim

Study Results

No Results Posted as of Jan 23, 2019