Trial Outcomes & Findings for Botox for Cervical Dystonia Following EMG Mapping (NCT NCT00773253)

NCT ID: NCT00773253

Last Updated: 2020-03-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: pre-injection, week 16, 20, 36, and 40
• Results posted on: 2020-03-23

Participant Flow

Participant milestones

Measure	Standard EMG Guided Injections Then Multi-channel Injections All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.	Multi-channel EMG-guided Botox Injection Then Standard EMG Inj Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
First Intervention (Week 0-24) STARTED	5	5
First Intervention (Week 0-24) COMPLETED	5	4
First Intervention (Week 0-24) NOT COMPLETED	0	1
Second Intervention (Week 24-48) STARTED	5	4
Second Intervention (Week 24-48) COMPLETED	5	4
Second Intervention (Week 24-48) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Standard EMG Guided Injections Then Multi-channel Injections All patients will undergo injection using conventional single channel (standard)EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.	Multi-channel EMG-guided Botox Injection Then Standard EMG Inj Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design.
First Intervention (Week 0-24) Frontalis Test Negative	0	1

Baseline Characteristics

Botox for Cervical Dystonia Following EMG Mapping

Baseline characteristics by cohort

Measure	Standard EMG Guided Injections Then Multi-channel n=5 Participants All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.	Multi-channel EMG-guided Botox Injection Then Single Channel n=5 Participants Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.	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
Age, Continuous	55.4 years STANDARD_DEVIATION 5.2 • n=5 Participants	54.7 years STANDARD_DEVIATION 5.1 • n=7 Participants	55.4 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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: pre-injection, week 16, 20, 36, and 40

Population: PI left institution. Efforts to contact PI to obtain data have been unsuccessful.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline and 48 weeks

Population: All participants that completed all phases of the study

Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).

Outcome measures

Measure	Standard EMG-guided Botox Injection n=9 Participants All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm. Botulinum toxin A: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.	Multi-channel EMG-guided Botox Injection n=9 Participants Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design. Botulinum toxin A: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale	9 percent change Standard Deviation 20.8	23.5 percent change Standard Deviation 15.7

Adverse Events

Standard EMG Guided Injections

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multi-channel EMG-guided Botox Injection

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

Graham A. Glass, MD

University of California San Francisco

Phone: 415-353-2311

Email: Graham.Glass@ucsf.edu

Results disclosure agreements

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