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Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

NCT ID: NCT01603459

Last Updated: 2017-04-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

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Detailed Description

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A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.

Conditions

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Spasticity of the Upper and Lower Limb Due to Cerebral Causes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IncobotulinumtoxinA (Xeomin) (up to 800 Units)

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection

Group Type EXPERIMENTAL

IncobotulinumtoxinA

Intervention Type DRUG

Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.

For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.

Interventions

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IncobotulinumtoxinA

Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.

For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Upper and lower limb spasticity of the same body side due to cerebral causes
* Time since event leading to spasticity in the target body side greater than 12 weeks
* Need for 800 units Botulinum toxin type A

Exclusion Criteria

* Body weight below 50kg
* Fixed contractures of the target joint
* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
* Infection at the injection site
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Expert

Role: STUDY_DIRECTOR

Merz Pharmaceuticals

Locations

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Merz Investigational Site # 001197

Doral, Florida, United States

Site Status

Merz Investigational Site # 001235

Indianapolis, Indiana, United States

Site Status

Merz Investigational Site # 001191

New York, New York, United States

Site Status

Merz Investigational Site #001238

Charlotte, North Carolina, United States

Site Status

Merz Investigational Site # 001232

Cleveland, Ohio, United States

Site Status

Merz Investigational Site #001237

Milwaukee, Wisconsin, United States

Site Status

Merz Investigational Site # 001203

Calgary, AB, , Canada

Site Status

Merz Investigational site #001195

Edmonton, AB, , Canada

Site Status

Merz Investigational Site # 033018

Garches, , France

Site Status

Merz Investigational Site #033049

Montpellier, , France

Site Status

Merz Investigational Site # 033050

Nîmes, , France

Site Status

Merz Investigational Site #049191

Aachen, , Germany

Site Status

Merz Investigational Site #049297

Bad Aibling, , Germany

Site Status

Merz Investigational Site #049022

Beelitz-Heilstätten, , Germany

Site Status

Merz Investigational Site #049298

Berlin, , Germany

Site Status

Merz Investigational Site # 049153

Giessen, , Germany

Site Status

Merz Investigational Site #049295

Göttingen, , Germany

Site Status

Merz Investigational Site #049300

Nümbrecht, , Germany

Site Status

Merz Investigational Site #049296

Tübingen, , Germany

Site Status

Merz Investigational Site # 039005

Lecco, , Italy

Site Status

Merz Investigational Site # 039010

Milan, , Italy

Site Status

Merz Investigational Site # 039015

Milan, , Italy

Site Status

Merz Investigational Site # 039017

Novara, , Italy

Site Status

Merz Investigational Site #039013

Passignano sul Trasimeno, , Italy

Site Status

Merz Investigational Site #039016

San Giovanni Rotondo, , Italy

Site Status

Merz Investigational Site #039014

Verona, , Italy

Site Status

Merz Investigational Site #047001

Bergen, , Norway

Site Status

Merz Investigational Site # 351003

Lisbon, , Portugal

Site Status

Merz Investigational Site # 351001

Lisbon, , Portugal

Site Status

Merz Investigational Site #034007

Madrid, , Spain

Site Status

Merz Investigational Site #034022

Manresa, , Spain

Site Status

Merz Investigational Site #034025

Málaga, , Spain

Site Status

Merz Investigational Site #034024

Santander, , Spain

Site Status

Countries

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United States Canada France Germany Italy Norway Portugal Spain

References

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Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baque B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.

Reference Type RESULT
PMID: 28283596 (View on PubMed)

Fheodoroff K, Scheschonka A, Wissel J. Goal analysis in patients with limb spasticity treated with incobotulinumtoxinA in the TOWER study. Disabil Rehabil. 2022 Apr;44(8):1367-1373. doi: 10.1080/09638288.2020.1804627. Epub 2020 Aug 17.

Reference Type DERIVED
PMID: 32805151 (View on PubMed)

Fheodoroff K, Rekand T, Medeiros L, Kossmehl P, Wissel J, Bensmail D, Scheschonka A, Flatau-Baque B, Simon O, Dressler D, Simpson DM. Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA. Health Qual Life Outcomes. 2020 Mar 4;18(1):51. doi: 10.1186/s12955-020-01304-4.

Reference Type DERIVED
PMID: 32131842 (View on PubMed)

Other Identifiers

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2010-020886-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ60201_3053_1

Identifier Type: -

Identifier Source: org_study_id

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