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The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT03609008
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

Tracking Information
First Submitted Date  ICMJE June 26, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Change is assessed of cranaial arteries; MMA, STA and MCA [ Time Frame: Before and after infusion of levcromakalim compared with before and after infusion of saline. Time of measurements is baseline, 20 min, 110 min, 200 min, 290 min and 350 min after the infusion. ]
The investigator will obtain repeated MRA measurements covering the diameter of MMA and MCA before and after levcromakalim/placebo infusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Headache [ Time Frame: Before (-10 min) and after infusion (+16 hours) of levcromakalim compared with before and after infusion of saline ]
Headache intensity will be recorded on a verbal rating scale (VRS) from 0 to 10 (0, no headache; 1, a feeling of pressure; 10, worst imaginable headache). Time of headache measurements is before (-10 min) and after infusion (+16 hours) of levcromakalim compared with before and after infusion of saline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.
Official Title  ICMJE The Effect of Levcromakalim Infusion on the Cranial Arteries Over Several Hours Using a High Resolution MRA Technique in a Randomized, Double-blind Placebo-controlled Design in Healthy Volunteers.
Brief Summary

Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min.

The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA circumference over several hours using a high resolution MRA technique in a randomized, double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized that levcromakalim induces dilatation of cranial arteries.

Detailed Description

Healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min.

The investigator here examine the effect of levcromakalim infusion on the MMA and the MCA circumference over several hours using a high resolution MRA technique in a randomized, double-blind placebo-controlled design in healthy volunteers. The investigator hypothesized that levcromakalim induces dilatation of cranial arteries.

MR imaging will be performed on a 3.0 Tesla Philips Achieva Scanner (Philips Medical Systems, Best, The Netherlands) using an eight-element phased-array receiver head coil. We will obtain repeated MRA measurements covering the MMA and MCA before and after levcromakalim/placebo infusion

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind placebo-controlled study with healthy volunteers.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Dilatation of Cranial Arteries; MMA, STA and MCA
  • Headache
Intervention  ICMJE
  • Drug: Levcromakalim
    Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.
  • Drug: Saline
    Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.
Study Arms  ICMJE
  • Active Comparator: Levcromakalim
    18 participants will randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline)
    Intervention: Drug: Levcromakalim
  • Placebo Comparator: Saline
    18 participants will randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline)
    Intervention: Drug: Saline
Publications * Al-Karagholi MA, Ghanizada H, Hansen JM, Skovgaard LT, Olesen J, Larsson HBW, Amin FM, Ashina M. Levcromakalim, an Adenosine Triphosphate-Sensitive Potassium Channel Opener, Dilates Extracerebral but not Cerebral Arteries. Headache. 2019 Oct;59(9):1468-1480. doi: 10.1111/head.13634. Epub 2019 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2018)
16
Actual Study Completion Date  ICMJE August 15, 2018
Actual Primary Completion Date August 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • A history of serious somatic disease
  • Migraine or any other type of headache (except episodic tension-type headache less than once a month)
  • Daily intake of any medication except contraceptives
  • Contraindications for MRI scan.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03609008
Other Study ID Numbers  ICMJE Levcromakalim & MRI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danish Headache Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP