Trial Outcomes & Findings for Phase I Study of Nicotinamide for Early Onset Preeclampsia (NCT NCT02213094)

NCT ID: NCT02213094

Last Updated: 2018-11-02

Results Overview

Specific adverse events were Maternal liver toxicity, defined as \> 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Within 48 hours of dosing
• Results posted on: 2018-11-02

Participant Flow

Participant milestones

Measure	Nicotinamide 500 mg Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Nicotinamide 1000 mg Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Overall Study STARTED	5	5
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Nicotinamide 500 mg Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Nicotinamide 1000 mg Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Overall Study Adverse Event	1	0

Baseline Characteristics

Phase I Study of Nicotinamide for Early Onset Preeclampsia

Baseline characteristics by cohort

Measure	Nicotinamide 500 mg n=5 Participants Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Nicotinamide 1000 mg n=5 Participants Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 48 hours of dosing

Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.

Outcome measures

Measure	Nicotinamide 500 mg n=5 Participants Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Nicotinamide 1000 mg n=5 Participants Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Number of Participants With Adverse Events	2 participants	0 participants

Adverse Events

Nicotinamide 500 mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotinamide 1000 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nicotinamide 500 mg n=5 participants at risk Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.	Nicotinamide 1000 mg n=5 participants at risk Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.
Renal and urinary disorders Renal failure	20.0% 1/5 • Number of events 1 • During study agent administration (up to 14 days)	0.00% 0/5 • During study agent administration (up to 14 days)
Hepatobiliary disorders Elevated LFTs	20.0% 1/5 • Number of events 1 • During study agent administration (up to 14 days)	0.00% 0/5 • During study agent administration (up to 14 days)

Other adverse events

Adverse event data not reported

Additional Information

Kim Boggess MD Principal Investigator

UNC at Chapel Hill

Phone: 919-966-1601

Email: kboggess@med.unc.edu

Results disclosure agreements

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