HeadachePhase 1NCT03212430
The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
A Phase 1 study testing L-kynurenine in people with Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To measure the cerebral hemodynamic effect of L-kynurenine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- L-kynurenine
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 20 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-90 kg.
- Women of childbearing potential must use adequate contraception.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet-Glostrup
Glostrup Municipality, Nordre Ringvej 57, 2600
About this study
To measure the cerebral hemodynamic effect of L-kynurenine.
Read the detailed description
Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.
Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.
Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.
The subjects will then have a questionnaire about headache for the following 24 hours.
- Conditions
- Headache
- Being tested
- L-kynurenine
- Keywords
- L-kynurenine, Cerebral hemodynamic, Headache, Mohammad Al-Mahdi Al-Karagholi
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-kynurenineDrug
intravenous infusion of L-kynurenine to healthy individuals.
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity of MCA (VMCA)
Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)
Measured: 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)
Measured: 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.
Measured: occurrence of headache undtil 24 hours after infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Mar 2017
- Primary completion20 Jan 2019
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Pilot, Open label
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
- Investigators
- Messoud Ashina, Professor, Principal investigator, Professor of neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212430
- Sponsor's protocol ID
- L-kynurenin H-16033148
- Status last verified
- Jan 2019
- First submitted
- 4 Jul 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous L-kynurenine (LKYN) on Cerebral Hemodynamics in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03212430
- Acronym / sponsor ID
- L-kynurenin H-16033148
- Conditions
- Headache
- Keywords
- L-kynurenine, Cerebral hemodynamic, Headache, Mohammad Al-Mahdi Al-Karagholi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure the cerebral hemodynamic effect of L-kynurenine.
Detailed description
Aim: To investigate the physiological effect of L-Kynurenine after intravenous administration to healthy volunteers.
Hypothesis: L-kynurenine induces vasodilation in the cerebral vessels and trigger headache in healthy individuals.
Methods: 6 healthy volunteers will receive intravenous infusion of L-kynurenine using the following doses 50 microgram/kg, 100 microgram/kg, 150 microgram/kg, 300 microgram/kg, 500 microgram/kg, 1 mg/kg and 5 mg/kg over 20 min on 7 different days with at least 1 day in between. Before and after infusion (at 20, 40, 60, 80 and 100 min) we will record vital signs, circumferences of middle cerebral artery, superficial temporalis artery and headache intensity and characteristics.
The subjects will then have a questionnaire about headache for the following 24 hours.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Model description
- Pilot, Open label
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers of both sexes.
- 18-60 years.
- 50-90 kg.
- Women of childbearing potential must use adequate contraception.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-kynurenineintravenous infusion of L-kynurenine to healthy individuals. | Drug | – |
Primary outcome
Velocity of MCA (VMCA)
Time frame: Change from baseline VMCA at two hours after administration of L-kynurenine
Measured in MCA (middle cerebral artery) bilaterally with ultrasound (TCD) (2 Mhz, DWL)
The diameter of the STA (superficial temporal artery)
Time frame: Change from baseline VMCA at two hours after administration of L-kynurenine
Measured by high-frequency ultrasound 12 of 29 (Derma Scan C, Cortex Technology, Denmark)
Headache
Time frame: occurrence of headache undtil 24 hours after infusion.
Headache declared orally on a verbal rating scale (VRS) 0-10. 0 represents no pain and 10 the worst possible headache.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, Professor principal investigator
Professor of neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-kynurenine in people with Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity of MCA (VMCA) (time frame: Change from baseline VMCA at two hours after administration of L-kynurenine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.