Trial Outcomes & Findings for Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials (NCT NCT00620698)

NCT ID: NCT00620698

Last Updated: 2014-09-25

Results Overview

The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.

• Recruitment status: COMPLETED
• Target enrollment: 89 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2014-09-25

Participant Flow

Participant milestones

Measure	ALS Patients Patients with clinically established amyotrophic lateral sclerosis
Overall Study STARTED	89
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials

Baseline characteristics by cohort

Measure	ALS Patients n=60 Participants Patients with clinically established amyotrophic lateral sclerosis
Age, Continuous	56.1 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.

Outcome measures

Measure	ALS Patients n=60 Participants Patients with clinically established amyotrophic lateral sclerosis
Electrical Impedance Myography	0.55 Coefficient of Variation Interval 0.41 to 0.69

SECONDARY outcome

Timeframe: 6 months

The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.

Outcome measures

Measure	ALS Patients n=60 Participants Patients with clinically established amyotrophic lateral sclerosis
ALS Functional Rating Scale	0.84 Coefficient of variation Interval 0.58 to 1.1

SECONDARY outcome

Timeframe: 6 months

The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.

Outcome measures

Measure	ALS Patients n=60 Participants Patients with clinically established amyotrophic lateral sclerosis
Handheld Dynamometry	0.925 Coefficient of variation Interval 0.626 to 1.23

Adverse Events

ALS Patients

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

Seward Rutkove

Beth Israel Deaconess Medical Center

Phone: 617-667-8130

Email: srutkove@bidmc.harvard.edu

Results disclosure agreements

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