Trial Outcomes & Findings for Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): (NCT NCT02027272)

NCT ID: NCT02027272

Last Updated: 2016-05-26

Results Overview

To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2016-05-26

Participant Flow

Participant milestones

Measure	Dexamethasone Dexamethasone 12 mg, 2 doses, 12 hours apart. Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart	Placebo Placebo, 2 doses, 12 hours apart
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES):

Baseline characteristics by cohort

Measure	Dexamethasone Dexamethasone 12 mg, 2 doses, 12 hours apart. Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart	Placebo n=1 Participants Placebo, 2 doses, 12 hours apart	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.

To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James N. Martin, Jr.

University of Mississippi Medical Center

Phone: 601-984-5358

Email: jnmartin@umc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place