Trial Outcomes & Findings for A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm (NCT NCT01814774)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

2 Years

Results posted on

2014-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants 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 Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=48 Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Age, Continuous	64.1 years STANDARD_DEVIATION 12.37 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

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

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

Outcome measures

Outcome measures
Measure	BOTOX® n=25 Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Xeomin® n=25 Participants Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Dose of Botulinum Toxin Used to Treat Cervical Dystonia	444.70 units per patient per year Interval 347.16 to 542.24	536.30 units per patient per year Interval 409.64 to 662.96

PRIMARY outcome

Timeframe: 2 Years

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

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

Outcome measures

Outcome measures
Measure	BOTOX® n=14 Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Xeomin® n=14 Participants Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Dose of Botulinum Toxin Used to Treat Blepharospasm	50.40 units per patient per year Interval 21.21 to 79.59	64.01 units per patient per year Interval 33.32 to 94.7

SECONDARY outcome

Timeframe: 2 Years

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

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.

Outcome measures

Outcome measures
Measure	BOTOX® n=48 Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Xeomin® n=48 Participants Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Number of Participants With Adverse Events	12 participants	10 participants

SECONDARY outcome

Timeframe: 2 Years

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

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

Outcome measures

Outcome measures
Measure	BOTOX® n=39 Participants Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Xeomin® n=39 Participants Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Botulinum Toxin Inter-injection Interval	15.83 weeks Standard Deviation 4.02	14.39 weeks Standard Deviation 3.38

Adverse Events

BOTOX®

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Xeomin®

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BOTOX® n=48 participants at risk Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.	Xeomin® n=48 participants at risk Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Gastrointestinal disorders Dysphagia	8.3% 4/48 • 2 Years	2.1% 1/48 • 2 Years
Eye disorders Ptosis	6.2% 3/48 • 2 Years	6.2% 3/48 • 2 Years

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER