NCT03212430

Brief Summary

To measure the cerebral hemodynamic effect of L-kynurenine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

July 4, 2017

Last Update Submit

January 20, 2019

Conditions

Headache

Keywords

L-kynurenineCerebral hemodynamicHeadacheMohammad Al-Mahdi Al-Karagholi

Outcome Measures

Primary Outcomes (3)

  • Velocity of MCA (VMCA)

    Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)

    Change from baseline VMCA at two hours after administration of L-kynurenine

  • The diameter of the STA (superficial temporal artery)

    Measured by high-frequency ultrasound 12 of 29 (Derma Scan C, Cortex Technology, Denmark)

    Change from baseline VMCA at two hours after administration of L-kynurenine

  • Headache

    Headache declared orally on a verbal rating scale (VRS) 0-10. 0 represents no pain and 10 the worst possible headache.

    occurrence of headache undtil 24 hours after infusion.

Interventions

L-kynurenineDRUG

intravenous infusion of L-kynurenine to healthy individuals.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers of both sexes.
  • years.
  • kg.
  • Women of childbearing potential must use adequate contraception.

You may not qualify if:

  • All primary headaches
  • First-degree relative with migraine
  • Headache less than 48 hours before the tests start
  • Daily consumption of drugs of any kind other than oral contraceptives.
  • Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet-Glostrup

Glostrup Municipality, Nordre Ringvej 57, 2600, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

Kynurenine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Messoud Ashina, Professor

    Professor of neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Pilot, Open label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student, Principal investigator

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

March 1, 2017

Primary Completion

January 20, 2019

Study Completion

January 20, 2019

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

1\. Using a controlled access approach, using a transparent and robust system to review requests and provide secure data access; 2. seeking consent for sharing IPD from trial participants in all future clinical trials with adequate assurance that patient privacy and confidentiality can be maintained; and 3. Establishing an approach to resource the sharing of IPD which would include support from trial funders, sponsor organisations and users of IPD

Locations

DK(1)