Trial Outcomes & Findings for Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks (NCT NCT00418145)

NCT ID: NCT00418145

Last Updated: 2017-05-18

Results Overview

There is no data analysis for this study

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Day 28 and Day 90

Results posted on

2017-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Total Study Participants Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
Overall Study STARTED	16
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Study Participants Overall study participants. Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
Overall Study study terminated	6

Baseline Characteristics

Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Study Participants n=16 Participants Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data.
Age, Customized age 18-29	6 participants n=5 Participants
Age, Customized age 30-39	3 participants n=5 Participants
Age, Customized age 40-49	7 participants n=5 Participants
Age, Customized age 50+	0 participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 and Day 90

Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.

There is no data analysis for this study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28 and day 90

Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28 and day 90 and day 365

Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28 and day 90

Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.

Outcome measures

Outcome data not reported

Adverse Events

Megadose Oral Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV Methylprednisolone

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

Dr. Fred Lublin

Icahn School of Medicine at Mount Sinai

Phone: 212-241-6854

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place