Peripheral Nociceptive Effects of Levcromakalim

NCT ID: NCT03726242

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Levcromakalim

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Parallel, randomized placebo controlled and crossover study
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Levcromakalim

Intervention Type DRUG

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

Saline

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Levcromakalim

Intervention Type DRUG

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

Saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levcromakalim

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammad Al-Mahdi Al-Karagholi

MD, PhD student, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish headache center

Glostrup Municipality, Copenhagen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Levcromakalim local injection

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RN624 For Pain Of Post-Herpetic Neuralgia
NCT00568321 COMPLETED PHASE2
Ketamine and Neuropathic Pain
NCT02467517 UNKNOWN PHASE2
Selective Nerve Stimulation (SNS) Pilot Study
NCT01259271 COMPLETED EARLY_PHASE1