Trial Outcomes & Findings for Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis (NCT NCT00537446)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

5 hours

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	High Level and Low Level Ventilation All participants are listed as one group, as the breakdown per Arm/Group is not available (PI no longer has raw data on file).
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Level and Low Level Ventilation n=8 Participants All participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 hours

Population: Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 hours

Population: Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 hours

Population: Data were collected but not analyzed as specified in the title because the sample size does not generate enough statistical significance. PI no longer has raw data on file. All efforts have been made to retrieve the data and data could not be recovered.

Outcome measures

Outcome data not reported

Adverse Events

High-level Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low-level Ventilation

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

Robert Basner, MD

Columbia University Irving Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place