Trial Outcomes & Findings for The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination (NCT NCT03367429)

Results Overview

BTME volume is calculated by counting the number of abnormal voxels (each voxel volume is .0015 cc) on MRI2, which have a relaxation time greater than or equal to 3 standard deviations above the baseline mean for a subject and their muscle found on their baseline MRI.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

At MRI 2, 2 Months after Research Injection

Results posted on

2021-12-29

Participant Flow

We are unable to locate the data for one subject.

Participant milestones

Participant milestones
Measure	Exp 1 - ARM 2 experimental injection in LGM	Exp 1 - ARM 3 experimental injection in MGM
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exp 1 - ARM 1 Standard injection in LGM	Exp 1 - ARM 2 n=1 Participants experimental injection in LGM	Exp 1 - ARM 3 n=2 Participants experimental injection in MGM	Total n=3 Participants Total of all reporting groups
Age, Continuous	—	60 years n=7 Participants	62 years n=5 Participants	61.3 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants

PRIMARY outcome

Timeframe: At MRI 2, 2 Months after Research Injection

Population: The data was never collected since Experiment 1 didn't yield enough participants or data to proceed with either a within subject or between subject study design for experiments 2 and 3.

BTME volume is calculated by counting the number of abnormal voxels (each voxel volume is .0015 cc) on MRI2, which have a relaxation time greater than or equal to 3 standard deviations above the baseline mean for a subject and their muscle found on their baseline MRI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At MRI 3, 2 Months after Clinical Injections

Population: The data was never collected since Experiment 1 didn't yield enough participants or data to proceed with either a within subject or between subject study design for experiments 2 and 3.

Change in volume of BTME in injected muscle after clinical injection recorded on MRI3 compared to BTME volume on MRI 2.

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Michael O'Dell, M.D.

Weill Cornell Medicine

Phone: 19175495179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place