Botox for Cervical Dystonia Following EMG Mapping

This study has been completed.

Sponsor:

Collaborator:

Allergan

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00773253

First received: October 14, 2008

Last updated: September 9, 2011

Last verified: September 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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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.
Total	Total of all reporting groups

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 ]

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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

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Other Adverse Events

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