PMRJ Vol. 9 No. 9S1

hemiparetic subjects who received abobotulinumtoxinA (Dysport ,

aboBoNT-A) in both UL and LL simultaneously.

Design:

Phase-III, open-label (OL) study (NCT01251367).

Setting:

52 centres;11 countries worldwide.

Participants:

Eligible subjects previously completed double-blind

(DB) placebo-controlled study (NCT01249404).

Interventions:

DB: aboBoNT-A 1000U or 1500U in LL for one treatment

cycle (TC). OL: repeated injections (up to 4 TC) performed over max18

months. Subjects received aboBoNT-A 1500U in LL for TC1/TC2; from

TC3 subjects could receive up to 500U in UL, providing total aboBoNT-

A dose did not exceed 1500U.

Main Outcome Measures:

Ten-meter comfortable barefoot walking

speed.

Results:

Of 352 subjects, 63 received co-injection in LL+UL at both

TC3/TC4, and 64 received injection in LL only. Mean (SD) aboBoNT-A

doses in LL at TC3 and TC4 were 1380U (210) and 1360U (220),

respectively, in subjects injected in LL only, and 1000U (50) and 1000U

(50), respectively, for subjects injected in LL+UL. At baseline, ten-

meter comfortable barefoot walking speed (mean [SD]) was similar in

subjects injected in LL+UL (0.42 [0.20]) and LL only (0.42 [0.20]). At

TC3 Wk4, both subgroups had improvements from baseline (mean

change [SD]: LL+UL: 0.063 [0.131]; LL only: 0.078 [0.114]), which

further improved to TC4 Wk4 ( LL+UL: 0.086 [0.166]; LL only: 0.086

[0.123]).

Conclusions:

In subjects with spastic paresis requiring concurrent

treatment of UL and LL, it was possible to split 1500U total dose of

aboBoNT-A between both extremities while still improving walking

speed similarly to that observed in subjects injected in lower ex-

tremities only. This provides important information for the treatment

of LL and UL simultaneously with aboBoNT-A in adult patients with

hemiparesis.

Level of Evidence:

Level I

Poster 65:

Efficacy of IncobotulinumtoxinA in the Treatment of

Shoulder Spasticity

John R. McGuire, MD, FAAPMR (Med Coll of WI, Milwaukee, WI,

United States), Jo¨rg Wissel, MD FRCP, Djamel Bensmail, MD,

Astrid Scheschonka, MD, PhD, Birgit Flatau-Baque´, MD, Olivier Simon,

MD, David M. Simpson, MD

Disclosures:

John McGuire: Speakers bureau

Allergan; Consulting

fees or other remuneration (payment)

Allergan, Medtronic; Research

Grants - Merz, Medtronic, Mallinckrodt

Objective:

To evaluate the efficacy and safety of incobotulinumtox-

inA to treat shoulder spasticity.

Design:

Post-hoc analysis of efficacy endpoints by clinical pattern and

patient-reported outcomes data from the TOWER study

(NCT01603459).

Setting:

Multiple international study sites.

Participants:

Adult subjects with upper limb post-stroke spasticity

155).

Interventions:

Escalating fixed doses of incobotulinumtoxinA admin-

istered to study subjects in 3 treatment cycles (400U, 600U and

600

800U).

Main Outcome Measures:

Assessments of muscle tone (Ashworth

Scale; AS) for all clinical patterns were conducted during the injection

visit and control visit (4-weeks post-injection). Seven upper limb

clinical patterns were treated and evaluated. A post-hoc analysis

compared subjects who received treatment in the shoulder with those

who did not. An AS shoulder sumscore (AS-SSS) was determined by

combining AS scores for shoulder adductors, extensors, and internal

rotators. The EQ-5D instrument was used to assess QoL. Adverse events

were monitored throughout.

Results:

A total of 84 subjects received incobotulinumtoxinA treat-

ment in the shoulder during cycle 3 (mean [standard deviation; SD]

shoulder dose 118.4 [60.2]U), and 57 subjects did not. Among

treated subjects, the mean [SD] AS-SSS improvement was -1.7 [1.8]

during cycle 3, compared with -0.9 [1.4] for those who were not

treated. Multiple regression analysis (adjusting for AS-SSS baseline)

revealed a significant dose dependence for effect of incobotuli-

numtoxinA on AS-SSS (P

.0081). Observed improvements in shoulder

muscle tone were similar to AS score improvements for other upper

limb clinical patterns. All dimensions of the EQ-5D improved across

injection cycles. No treatment-related AEs indicating toxin spread

from the shoulder to the lung (eg, respiratory depression) were

observed.

Conclusions:

Results suggest that incobotulinumtoxinA is safe and

effective for the treatment of shoulder spasticity and support further

clinical evaluation.

Level of Evidence:

Level II

Poster 66:

The Adult Spasticity International Registry (ASPIRE)

Study: Treatment Utilization Patterns in Patients

Treated for Both Upper and Lower Limb Spasticity

Gerard E. Francisco, MD, FAAPMR (Univ. of Texas and TIRR Memorial

Hermann, Houston, TX, United States), Daniel S. Bandari, MD,

Ganesh Bavikatte, MD, FRCP, FEBPRM, Wolfgang H. Jost, MD, PhD,

Aubrey Manack Adams, PhD, Joan Largent, PhD, MPH,

Alberto Esquenazi, MD, FAAPMR

Disclosures:

Gerard Francisco: Research Grants - Allergan, Ipsen,

Mallinckrodt, Medtronic, Merz, Microtransponder, Nexstim

Objective:

To examine the treatment patterns of onabotulinumtoxinA

utilization in patients treated for upper and lower limb spasticity, in

combination, from the ASPIRE study (1 year interim results).

Design:

Multicenter, prospective, observational study (NCT01930786).

Setting:

54 international clinical sites.

Participants:

Adult patients ( 18 years) with focal spasticity related

to upper motor neuron syndrome.

Interventions:

OnabotulinumtoxinA administered with treatment

dosing at intervals at the treating physician’s discretion in accordance

with usual clinical practice.

Main Outcome Measures:

Treatment utilization patterns.

Results:

A total of 256 patients were treated for both upper and

lower limb spasticity across 648 treatment sessions at the 1 year

interim data cut. The average total dose administered to the upper

and lower limbs was 468 U (SD

186). The majority of treatment

sessions occurred at a dosing interval of 10-15 weeks (n

236/392,

60.2%) or

15 weeks (n

153/392, 39.0%). Muscles in the upper and

lower limbs received a total of 5-15 injections in 62.3% of treatment

sessions (n

404/648) and

15 injections in 36.3% of treatment ses-

sions (n

235/648). Greater than 5 upper and lower limb muscles

were injected during the majority of treatment sessions (n

530/648,

81.8%). No new safety concerns were identified for the total popu-

lation at the 1 year interim analyses.

Conclusions:

The 1 year interim results of this study provide insight

into the real-world treatment patterns of onabotulinumtoxinA in adult

patients treated concurrently for both upper and lower limb spasticity

and may be informative to clinicians.

Level of Evidence:

Level IV

Poster 67:

Posterior Circulation Cerebellar Stroke Symptoms

Prolong Acute Rehabilitation Stay

Rebecca H. Siegel (Ohio State Univ Col of Med), Kristofer J. Feeko,

DO, David A. Janerich, DO

Disclosures:

Rebecca Siegel: I Have No Relevant Financial Relation-

ships To Disclose

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Abstracts / PM R 9 (2017) S131-S290