A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01814774
• Collaborator: (none)
• Enrollment: 48
• Locations: 2
• Duration (Months): 5.9
• Patients Per Site: 24
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Cervical Dystonia; Blepharospasm	Other: No Intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
BOTOX® Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Other: No Intervention; No treatment (intervention) was administered.
Xeomin® Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Other: No Intervention; No treatment (intervention) was administered.

Outcome Measures

Primary Outcome Measures

1. Dose of Botulinum Toxin Used to Treat Cervical Dystonia [2 Years]

   The average dose of botulinum toxin received per patient per year was calculated.

2. Dose of Botulinum Toxin Used to Treat Blepharospasm [2 Years]

   The average dose of botulinum toxin received per patient per year was calculated.

Secondary Outcome Measures

1. Number of Participants With Adverse Events [2 Years]

   An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.

2. Botulinum Toxin Inter-injection Interval [2 Years]

   Injection-interval was the time in weeks between injections of botulinum toxin.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years

• treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

• having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission

• previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bergen		Norway
2		Wakefield		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01814774
• Other Study ID Numbers: TRU2011
• First Posted: Mar 20, 2013
• Last Update Posted: Jul 3, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Dystonia; Dystonic Disorders; Blepharospasm; Torticollis

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Period Title: Overall Study
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Overall Participants	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (12.37)
Sex: Female, Male (Count of Participants)
Female	35 72.9%
Male	13 27.1%

Outcome Measures

1. Primary Outcome

Title	Dose of Botulinum Toxin Used to Treat Cervical Dystonia
Description	The average dose of botulinum toxin received per patient per year was calculated.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.

Arm/Group Title	BOTOX®	Xeomin®
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Measure Participants	25	25
Mean (95% Confidence Interval) [units per patient per year]	444.70	536.30

2. Primary Outcome

Title	Dose of Botulinum Toxin Used to Treat Blepharospasm
Description	The average dose of botulinum toxin received per patient per year was calculated.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.

Arm/Group Title	BOTOX®	Xeomin®
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Measure Participants	14	14
Mean (95% Confidence Interval) [units per patient per year]	50.40	64.01

3. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one dose of botulinum toxin.

Arm/Group Title	BOTOX®	Xeomin®
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Measure Participants	48	48
Number [participants]	12 25%	10 NaN

4. Secondary Outcome

Title	Botulinum Toxin Inter-injection Interval
Description	Injection-interval was the time in weeks between injections of botulinum toxin.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.

Arm/Group Title	BOTOX®	Xeomin®
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Measure Participants	39	39
Mean (Standard Deviation) [weeks]	15.83 (4.02)	14.39 (3.38)

Adverse Events

Time Frame	2 Years
Arm/Group Title	BOTOX®		Xeomin®
Arm/Group Description	Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.		Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
All Cause Mortality
	BOTOX®		Xeomin®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BOTOX®		Xeomin®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	BOTOX®		Xeomin®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/48 (14.6%)		4/48 (8.3%)
Eye disorders
Ptosis	3/48 (6.3%)		3/48 (6.3%)
Gastrointestinal disorders
Dysphagia	4/48 (8.3%)		1/48 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.