MitoQ for Pre-eclampsia

(MAVEN Trial)

Overseen By Jennifer McIntosh, D.O., M.S.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality. There is a lack of effective therapeutics for prevention or treatment. Our previous ex vivo work demonstrated that mitochondrial-antioxidants can reverse placental microvascular damage. Therefore, this study will evaluate whether MitoQ (Mitoquinol Mesylate, a mitochondrial-antioxidant) has the potential to restore vasodilation, improve placental function, and therefore promote pregnancy prolongation in patients with preeclampsia. This evaluation of clinical data, patient samples, and vascular function studies in patients with preeclampsia could translate into a viable therapeutic option.

Who Is on the Research Team?

Jennifer J McIntosh, D.O.,

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18-50, pregnant with one baby, have severe preeclampsia, and am 23-32 weeks along.

I am 18-50, pregnant with one baby, have mild preeclampsia, and can manage care at home.

Exclusion Criteria

Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg

Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator

I have peripheral vascular disease.

What Are the Treatments Tested in This Trial?

Interventions

• Mitoquinol Mesylate

How Is the Trial Designed?

Group I: Preeclampsia without Severe Features taking MitoQ Experimental Treatment 1 Intervention

Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

Group II: Preeclampsia with Severe Features taking Mitoquinol Mesylate Experimental Treatment 1 Intervention

Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive 10mg of Mitoquinol Mesylate daily from enrollment until delivery.

Group III: Preeclampsia with Severe Features taking placebo Placebo Group 1 Intervention

Patients allocated to this arm will be inpatients who have preeclampsia with severe features. They will receive Placebo daily from enrollment until delivery.

Group IV: Preeclampsia without Severe Features taking placebo Placebo Group 1 Intervention

Patients allocated to this arm will be out-patients who have preeclampsia without severe features. They will receive placebo daily from enrollment until delivery.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+