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Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

NCT ID: NCT01392300

Last Updated: 2017-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.

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ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

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Study of Responsiveness of Seven Functional Tasks in Patients With Poststroke Upper Limb Spasticity With Botulinum Toxin Type A Treatment

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Detailed Description

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The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).

Conditions

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Post-stroke Spasticity of the Upper Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DB IncobotulinumtoxinA (Xeomin) (400 U)

IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Group Type EXPERIMENTAL

IncobotulinumtoxinA (400 Units)

Intervention Type DRUG

Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection

DB Placebo Comparator

Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Interventions

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IncobotulinumtoxinA (400 Units)

Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection

Intervention Type DRUG

Placebo Comparator

Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Intervention Type DRUG

Other Intervention Names

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Xeomin

Eligibility Criteria

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Inclusion Criteria

* Upper limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A

Exclusion Criteria

* Body weight below 50kg
* Fixed contractures of the upper limb
* 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 GmbH

Locations

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Merz Investigational Site #001184

Downey, California, United States

Site Status

Merz Investigational Site #001017

Fountain Valley, California, United States

Site Status

Merz Investigational Site #001188

Miami, Florida, United States

Site Status

Merz Investigational Site #001037

Augusta, Georgia, United States

Site Status

Merz Investigational Site #001186

Chicago, Illinois, United States

Site Status

Merz Investigational Site # 001110

Overland Park, Kansas, United States

Site Status

Merz Investigational Site #001198

Stratford, New Jersey, United States

Site Status

Merz Investigational Site #001240

Chapel Hill, North Carolina, United States

Site Status

Merz Investigational Site #001009

Winston-Salem, North Carolina, United States

Site Status

Merz Investigational Site #001241

Philadelphia, Pennsylvania, United States

Site Status

Merz Investigational Site #001211

Pittsburgh, Pennsylvania, United States

Site Status

Merz Investigational Site #001245

Chattanooga, Tennessee, United States

Site Status

Merz Investigational Site #001226

Houston, Texas, United States

Site Status

Merz Investigational Site #420046

Brno, , Czechia

Site Status

Merz Investigational Site #420029

Brno, , Czechia

Site Status

Merz Investigational Site #420028

Olomouc, , Czechia

Site Status

Merz Investigational Site #420024

Ostrava-Poruba, , Czechia

Site Status

Merz Investigational Site #420025

Pardubice, , Czechia

Site Status

Merz Investigational Site #420030

Prague, , Czechia

Site Status

Merz Investigational Site #420045

Prague, , Czechia

Site Status

Merz Investigational Site #420047

Rychnov nad Kněžnou, , Czechia

Site Status

Merz Investigational Site #049134

Rostock, , Germany

Site Status

Merz Investigational Site #036004

Budapest, , Hungary

Site Status

Merz Investigational Site # 036009

Budapest, , Hungary

Site Status

Merz Investigational Site #036005

Nyíregyháza, , Hungary

Site Status

Merz Investigational Site #036008

Szeged, , Hungary

Site Status

Merz Investigational Site #091003

Porur, Chennai, India

Site Status

Merz Investigational Site #091006

Bangalore, Karnataka, India

Site Status

Merz Investigational Site #091002

Trivandrum, Kerala, India

Site Status

Merz Investigational Site #091004

New Delhi, New Delhi, India

Site Status

Merz Investigational Site #091007

Chennai, Tamil Nadu, India

Site Status

Merz Investigational Site #091008

Coimbatore, Tamil Nadu, India

Site Status

Merz Investigational Site #091001

Lucknow, Uttar Pradesh, India

Site Status

Merz Investigational Site # 048029

Gdansk, , Poland

Site Status

Merz Investigational Site #048044

Kielce, , Poland

Site Status

Merz Investigational Site #048031

Krakow, , Poland

Site Status

Merz Investigational Site #048050

Lodz, , Poland

Site Status

Merz Investigational Site #048051

Lublin, , Poland

Site Status

Merz Investigational Site #048032

Olsztyn, , Poland

Site Status

Merz Investigational Site #048053

Poznan, , Poland

Site Status

Merz Investigational Site #048023

Warsaw, , Poland

Site Status

Merz Investigational Site #048052

Warsaw, , Poland

Site Status

Merz Investigational Site #048033

Warsaw, , Poland

Site Status

Merz Investigational Site #007010

Krasnoyarsk, , Russia

Site Status

Merz Investigational Site #007011

Moscow, , Russia

Site Status

Merz Investigational Site #007009

Saint Petersburg, , Russia

Site Status

Merz Investigational Site #007005

Stavropol, , Russia

Site Status

Countries

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United States Czechia Germany Hungary India Poland Russia

References

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Elovic EP, Munin MC, Kanovsky P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxina for upper-limb post-stroke spasticity. Muscle Nerve. 2016 Mar;53(3):415-21. doi: 10.1002/mus.24776. Epub 2015 Dec 15.

Reference Type RESULT
PMID: 26201835 (View on PubMed)

Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Treatment in Upper-Limb Poststroke Spasticity in the Open-Label Extension Period of PURE: Efficacy in Passive Function, Caregiver Burden, and Quality of Life. PM R. 2020 May;12(5):491-499. doi: 10.1002/pmrj.12265. Epub 2020 Jan 22.

Reference Type DERIVED
PMID: 31647185 (View on PubMed)

Marciniak C, Munin MC, Brashear A, Rubin BS, Patel AT, Slawek J, Hanschmann A, Hiersemenzel R, Elovic EP. IncobotulinumtoxinA Efficacy and Safety in Adults with Upper-Limb Spasticity Following Stroke: Results from the Open-Label Extension Period of a Phase 3 Study. Adv Ther. 2019 Jan;36(1):187-199. doi: 10.1007/s12325-018-0833-7. Epub 2018 Nov 27.

Reference Type DERIVED
PMID: 30484117 (View on PubMed)

Other Identifiers

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2010-023043-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRZ 60201/SP/3001

Identifier Type: -

Identifier Source: org_study_id

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