Botox for Cervical Dystonia Following EMG Mapping

This study has been completed.

Study NCT00773253 Information provided by University of California, San Francisco

First Received on October 14, 2008. Last Updated on September 9, 2011 History of Changes

Results First Received: February 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cervical Dystonia
Intervention:	Drug: Botulinum toxin A

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 2 periods

Period 1: First Intervention (Week 0-24)

	Standard EMG Guided Injections Then Multi-channel Injections	Multi-channel EMG-guided Botox Injection Then Standard EMG Inj
STARTED	5	5
COMPLETED	5	4
NOT COMPLETED	0	1
Frontalis Test Negative	0	1

Period 2: Second Intervention (Week 24-48)

	Standard EMG Guided Injections Then Multi-channel Injections	Multi-channel EMG-guided Botox Injection Then Standard EMG Inj
STARTED	5	4
COMPLETED	5	4
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Standard EMG Guided Injections Then Multi-channel	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	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.

Baseline Measures

	Standard EMG Guided Injections Then Multi-channel	Multi-channel EMG-guided Botox Injection Then Single Channel	Total
Number of Participants [units: participants]	5	5	10
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	5	5	10
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	55.4 ± 5.2	54.7 ± 5.1	55.4 ± 5.2
Gender [units: participants]
Female	2	2	4
Male	3	3	6
Region of Enrollment [units: participants]
United States	5	5	10

Outcome Measures

1. Primary:

Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale [ Time Frame: 48 weeks ]

Show Outcome Measure 1

2. Primary:

Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS) [ Time Frame: pre-injection, week 16, 20, 36, and 40 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One patient received single channel injection, but did not get multi-channel injection because the frontalis test showed immunity to botulinum toxin indicating no possibility of clinical benefit. This is an exclusion criterion.

Results Point of Contact:

Name/Title: Graham A. Glass, MD
Organization: University of California San Francisco
phone: 415-353-2311
e-mail: Graham.Glass@ucsf.edu

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00773253 History of Changes
Other Study ID Numbers:	Allergan cervical dystonia
Study First Received:	October 14, 2008
Results First Received:	February 15, 2011
Last Updated:	September 9, 2011
Health Authority:	United States: Institutional Review Board