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Medications for Cerebral Blood Flow Regulation (Gas Challenge Trial)

Q: Can I partake in this research project if I meet the criteria?

This medical research requires 144 individuals, aged between 18 and 40 with cerebral arterial diseases. Furthermore, <a href="https://www.withpower.com/clinical-trials/all">all</a> participants must be non-hypertensive (&#x3C;125/80mm Hg), have normal lipids (LDL <a href="https://www.withpower.com/clinical-trials/cholesterol">cholesterol</a> &#x3C;130 mg/dl, triglycerides &#x3C;150 mg/dl) , not obese (BMI 19-25 kg/m2), possess regular blood glucose levels (&#x3C;100 g/dl) and women need to have natural menstrual cycles to qualify for the study.

Q: How many participants are enrolled in this experiment?

Indeed, the information hosted on clinicaltrials.gov attests to this trial's active recruitment status. The initial posting was dated April 12th 2021 and underwent its last update on July 1st 2022. This research endeavour seeks 144 participants from a single medical centre for enrolment.

Q: What advantages does the use of L-NMMA provide to clinicians?

L-NMMA is frequently used in therapeutic procedures, and can be a successful treatment for <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>, hypogonadism, as well as pupil dilation.

Q: Is recruitment for this medical trial still open to new participants?

Indeed, the page on clinicaltrials.gov attests to this trial's active recruitment of participants. The first posting was seen on April 12th 2021 and the information has since been updated as recently as July 1st 2022.

Q: Have other investigations explored the effects of L-NMMA?

Presently, 121 clinical trials concerning L-NMMA are underway with 21 of those currently in Phase 3. Although many experiments take place in Boston, <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>; there is an expansive network of 743 sites conducting tests involving the drug.

Q: Is this research protocol open to those below the age of 55?

Eligibility requirements for this study restrict patient age to between 18 and 40 years old. In contrast, there are 15 alternative trials available for those younger than 18 and 66 options open to elderly participants above 65.

Phase < 1

Recruiting

Led By William Schrage, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be healthy adults between 18-40 years old, matched for age and aerobic fitness

Women must have a natural regular menstrual cycle

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes

Awards & highlights

Gas Challenge Trial Summary

This trial is testing whether men and women have different ways of controlling blood flow to the brain. The stress is low oxygen or high carbon dioxide. The study will use medicine infusions during stress and MRI to measure brain blood flow.

Who is the study for?

Healthy adults aged 18-40 with normal blood pressure, body mass index (BMI) between 19-25, regular menstrual cycles for women, and good cholesterol levels. Excluded are those with a history of stroke, diabetes, kidney or blood diseases, obesity, sleep apnea; smokers; users of hormonal birth control or cardiovascular meds; pregnant women; and anyone unable to undergo MRI.Check my eligibility

What is being tested?

The study is examining how men and women regulate brain blood flow at rest and under stress from low oxygen or high carbon dioxide. It involves infusions of Ganirelix Acetate, L-NMMA, Ketorolac Tromethamine along with Estradiol Topical for women and Testosterone Transdermal Product for men while using advanced MRI to measure changes in cerebral blood flow.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site such as pain or swelling, hormone-related effects like mood swings or skin changes due to topical estradiol/testosterone application. The impact on organ function will be monitored closely during the trial.

Gas Challenge Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy adult aged 18-40 with good aerobic fitness.

Select...

I have a regular menstrual cycle without any interventions.

Gas Challenge Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 75 minutes for entire visit, but hypercapnia lasts about 10-15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CVC change in response to Drug Infusion

CVC in response to Hypercapnia

Cerebrovascular Conductance (CVC) in response to Hypoxia

+3 more

Side effects data

From 2017 Phase 4 trial • 44 Patients • NCT01701973

20%

Dizziness and paresthesias during arginine infusion

20%

Abdominal cramping and diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sitagliptin Plus Pegvisomant

Sitagliptin Plus LNMMA

Sitagliptin

Sitagliptin Plus Exendin 9-39

Gas Challenge Trial Design

4Treatment groups

Experimental Treatment

Group I: Male NOSExperimental Treatment3 Interventions

Males visit MRI twice. Once for hypercapnia visit (no drugs), and once for hypoxia visit (IV and drug infusion to inhibit NOS). CBF measured via MRI sequences, and hemodynamics monitored for safety/research.

Group II: Male COXExperimental Treatment3 Interventions

Males visit MRI twice. Once for hypercapnia visit (no drugs), and once for hypoxia visit (IV and drug infusion to inhibit COX). CBF measured via MRI sequences, and hemodynamics monitored for safety/research.

Group III: Female NOSExperimental Treatment3 Interventions

Females visit MRI twice. Once for hypercapnia visit (no drugs), and once for hypoxia visit (IV and drug infusion to inhibit NOS). CBF measured via MRI sequences, and hemodynamics monitored for safety/research.

Group IV: Female COXExperimental Treatment3 Interventions

Females visit MRI twice. Once for hypercapnia visit (no drugs), and once for hypoxia visit (IV and drug infusion to inhibit COX). CBF measured via MRI sequences, and hemodynamics monitored for safety/research.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-NMMA

2010

Completed Phase 4

~420

Ketorolac Tromethamine

2007

Completed Phase 4

~1450

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,243 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,526 Total Patients Enrolled

William Schrage, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

2 Previous Clinical Trials

38 Total Patients Enrolled

Media Library

L-NMMA Clinical Trial Eligibility Overview. Trial Name: NCT04265053 — Phase < 1

Cerebral Artery Disease Research Study Groups: Male COX, Male NOS, Female COX, Female NOS

Cerebral Artery Disease Clinical Trial 2023: L-NMMA Highlights & Side Effects. Trial Name: NCT04265053 — Phase < 1

L-NMMA 2023 Treatment Timeline for Medical Study. Trial Name: NCT04265053 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I partake in this research project if I meet the criteria?

"This medical research requires 144 individuals, aged between 18 and 40 with cerebral arterial diseases. Furthermore, all participants must be non-hypertensive (<125/80mm Hg), have normal lipids (LDL cholesterol <130 mg/dl, triglycerides <150 mg/dl) , not obese (BMI 19-25 kg/m2), possess regular blood glucose levels (<100 g/dl) and women need to have natural menstrual cycles to qualify for the study."

Answered by AI

How many participants are enrolled in this experiment?

"Indeed, the information hosted on clinicaltrials.gov attests to this trial's active recruitment status. The initial posting was dated April 12th 2021 and underwent its last update on July 1st 2022. This research endeavour seeks 144 participants from a single medical centre for enrolment."

Answered by AI

What advantages does the use of L-NMMA provide to clinicians?

"L-NMMA is frequently used in therapeutic procedures, and can be a successful treatment for prostate cancer, hypogonadism, as well as pupil dilation."

Answered by AI

Is recruitment for this medical trial still open to new participants?

"Indeed, the page on clinicaltrials.gov attests to this trial's active recruitment of participants. The first posting was seen on April 12th 2021 and the information has since been updated as recently as July 1st 2022."

Answered by AI

Have other investigations explored the effects of L-NMMA?

"Presently, 121 clinical trials concerning L-NMMA are underway with 21 of those currently in Phase 3. Although many experiments take place in Boston, Massachusetts; there is an expansive network of 743 sites conducting tests involving the drug."

Answered by AI

Is this research protocol open to those below the age of 55?

"Eligibility requirements for this study restrict patient age to between 18 and 40 years old. In contrast, there are 15 alternative trials available for those younger than 18 and 66 options open to elderly participants above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Human Cerebral Blood Flow Regulation

2021. "Human Cerebral Blood Flow Regulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04265053.

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