Peripheral Nociceptive Effects of Levcromakalim

January 20, 2019 updated by: Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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 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.
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 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

January 20, 2019

Study Completion (Actual)

January 20, 2019

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 20, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levcromakalim local injection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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