Botox for Cervical Dystonia Following EMG Mapping

NCT00773253 | Completed Phase 4 Results

• 1 other identifier: Allergan cervical dystonia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.

Conditions

Cervical Dystonia

Keywords

dystonia; cervical dystonia; Botox; idiopathic primary cervical dystonia

Outcome Measures

Primary Outcomes (2)

• Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)

  pre-injection, week 16, 20, 36, and 40

• Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale

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

  baseline and 48 weeks

Study Arms (2)

standard EMG-guided Botox injection

ACTIVE COMPARATOR

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.

Drug: Botulinum toxin A

Multi-channel EMG-guided Botox injection

EXPERIMENTAL

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.

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.

Also known as: Botox

Multi-channel EMG-guided Botox injection; standard EMG-guided Botox injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18 to 75 years of age.
• Ability to follow study instructions and complete all required visits.
• Subject meets diagnostic criteria for idiopathic primary cervical dystonia.
• Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.
• Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility.
• Patients will not have received Botulinum toxin within 16 weeks of the start of the study.
• In order to not confound the clinical response to BTX-A injections, all patients enrolled must have been on a stable medication regimen for 30 days. If they are not on medication at the initiation of the study, they will not be started on medication. Patients must be on the same medication regimen through the entire study including assessment of both single lead EMG based injections and "mapping" based injections. Medications cannot be stopped during the study to avoid confounding the clinical response to BTX-A.

You may not qualify if:

• Known allergy or sensitivity to any of the components in BTX-A.
• Uncontrolled clinically significant medical condition other than the condition under evaluation
• Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
• Participation in another medication or device study or within 3 months of enrollment in this study.
• Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded.
• Any known evidence of cervical contractures or significant spinal deformity.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Allergan: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Torticollis; Dystonia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

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

• Title: Graham A. Glass, MD
• Organization: University of California San Francisco

Graham.Glass@ucsf.edu

415-353-2311

Study Officials

• Graham A. Glass, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 23, 2020
• Results First Posted: October 13, 2011

Record last verified: 2020-03

Locations

US (1)