Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke - Clinical Trial for Post-stroke Spasticity of the Lower Limb | NCT01464307

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

IncobotulinumtoxinA (400 Units)

Placebo Comparator

About this trial

This is an interventional treatment trial for Post-stroke Spasticity of the Lower Limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age from 18-80 yrs
Lower 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 lower limb
Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
Infection at the injection site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IncobotulinumtoxinA (Xeomin) 400 Units

Placebo Comparator Arm

Arm Description

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.

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Outcomes

Primary Outcome Measures

Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4

The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12

A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.

Secondary Outcome Measures

Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)

Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits

The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.

Full Information

NCT ID

NCT01464307

First Posted

November 1, 2011

Last Updated

November 4, 2016

Sponsor

Merz Pharmaceuticals GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01464307

Brief Title

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

Acronym

PLUS

Official Title

Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-stroke Spasticity of the Lower Limb

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

290 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IncobotulinumtoxinA (Xeomin) 400 Units

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Comparator Arm

Arm Type

Placebo Comparator

Arm Description

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Intervention Type

Drug

Intervention Name(s)

IncobotulinumtoxinA (400 Units)

Intervention Description

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

Intervention Name(s)

Placebo Comparator

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4

Description

The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Time Frame

Baseline and Week 4

Title

Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12

Description

A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.

Time Frame

Baseline to Week 12

Secondary Outcome Measure Information:

Title

Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)

Description

Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

Time Frame

Week 4, 8, and 12

Title

Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits

Description

The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.

Time Frame

Baseline, Week 4, 8, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age from 18-80 yrs Lower 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 lower limb Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A Infection at the injection site

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Expert

Organizational Affiliation

Merz Pharmaceuticals GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Merz Investigational Site #001184

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

Merz Investigational Site #001208

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Merz Investigational Site #001244

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Investigational site #001188

City

Doral

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

Merz Investigational Site # 001110

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Merz Investigational Site #001209

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Merz Investigational Site #001210

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Merz Investigational Site #001198

City

Stratford

State/Province

New Jersey

ZIP/Postal Code

08084

Country

United States

Facility Name

Merz Investigational Site #001207

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Merz Investigational Site #001009

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Merz Investigational Site #001206

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Merz Investigational Site #001183

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Merz Investigational Site #001204

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 4K4

Country

Canada

Facility Name

Merz Investigational Site #001202

City

Winnipeg

ZIP/Postal Code

MB R3A 1M4

Country

Canada

Facility Name

Merz Investigational Site #420024

City

Ostrava-Poruba

ZIP/Postal Code

70852

Country

Czech Republic

Facility Name

Merz Investigational Site #420031

City

Ostrava-Vitkovice

ZIP/Postal Code

70384

Country

Czech Republic

Facility Name

Merz Investigational Site #420030

City

Praha

ZIP/Postal Code

12000

Country

Czech Republic

Facility Name

Merz Investigational Site #420047

City

Rychnov nad Kneznou

ZIP/Postal Code

51601

Country

Czech Republic

Facility Name

Merz Investigational Site #033018

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

Merz Investigational Site #033024

City

Rennes

ZIP/Postal Code

35043

Country

France

Facility Name

Merz Investigational Site #049022

City

Beelitz-Heilstätten

ZIP/Postal Code

14547

Country

Germany

Facility Name

Merz Investigational Site #049071

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Merz Investigational Site #049079

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Merz Investigational Site #049304

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Merz Investigational Site #049072

City

München

ZIP/Postal Code

80804

Country

Germany

Facility Name

Merz Investigational Site #049148

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Merz Investigational Site #049303

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Merz Investigational Site #049302

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Merz Investigational Site #039006

City

Messina

ZIP/Postal Code

98125

Country

Italy

Facility Name

Merz Investigational Site #039011

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Merz Investigational Site #039012

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Merz Investigational Site #048057

City

Gdansk

ZIP/Postal Code

80-462

Country

Poland

Facility Name

Merz Investigational Site #048044

City

Kielce

ZIP/Postal Code

25-103

Country

Poland

Facility Name

Merz Investigational Site #048080

City

Krakow

ZIP/Postal Code

30-349

Country

Poland

Facility Name

Merz Investigational Site #048054

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Merz Investigational Site #048031

City

Krakow

ZIP/Postal Code

31-505

Country

Poland

Facility Name

Merz Investigational Site #048022

City

Lodz

ZIP/Postal Code

90-130

Country

Poland

Facility Name

Merz Investigational Site #048051

City

Lublin

ZIP/Postal Code

20-022

Country

Poland

Facility Name

Merz Investigational Site #048053

City

Poznan

ZIP/Postal Code

61-485

Country

Poland

Facility Name

Merz Investigational Site #048081

City

Poznan

ZIP/Postal Code

61-853

Country

Poland

Facility Name

Merz Investigational Site #048055

City

Warszawa

ZIP/Postal Code

01-697

Country

Poland

Facility Name

Merz Investigational Site #048023

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Merz Investigational Site #048056

City

Warszawa

ZIP/Postal Code

02097

Country

Poland

Facility Name

Merz Investigational Site #048033

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

Facility Name

Merz Investigational Site #007010

City

Krasnoyarsk

ZIP/Postal Code

660037

Country

Russian Federation

Facility Name

Merz Investigational Site #007011

City

Moscow

ZIP/Postal Code

105005

Country

Russian Federation

Facility Name

Merz Investigational Site #007009

City

St. Petersburg

ZIP/Postal Code

129019

Country

Russian Federation

Facility Name

Merz Investigational Site #007012

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Merz Investigational Site #034027

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Merz Investigational Site #034028

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Merz Investigational Site #034026

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Merz Investigational Site #034030

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Merz Investigational Site #034029

City

Terrassa

ZIP/Postal Code

08221

Country

Spain

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke (PLUS)

Post-stroke Spasticity of the Lower Limb

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial