Botulinum Toxin Type A Preparation Free of Complexing Proteins, in the Treatment of Arm Tightness After a Stroke

This study has been completed.

First Received: February 7, 2007 Last Updated: May 11, 2009 History of Changes

Sponsor:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00432666

Purpose

NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of NT 201 in the treatment of arm tightness after a stroke

Condition	Intervention	Phase
Post-Stroke Upper Limb Spasticity	Drug: Botulinum Neurotoxin Type A	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Botulinum Toxin Type A Preparation Free of Complexing Proteins, in the Treatment of Arm Tightness After a Stroke

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Ashworth Score in wrist flexors [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ashworth Score in various upper limb muscle groups [ Designated as safety issue: No ]

Enrollment:	148
Study Start Date:	June 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Botulinum Neurotoxin Type A: Experimental	Drug: Botulinum Neurotoxin Type A
Placebo: Placebo Comparator	Drug: Botulinum Neurotoxin Type A

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist)
focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist
focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist

Exclusion Criteria:

spasticity of any other origin than stroke
Fixed contracture

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432666

Locations

Czech Republic

Czech Republic, Czech Republic
Hungary

Hungary, Hungary
Poland

Poland, Poland

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Chair:	Merz Pharmaceuticals	Merz Pharmaceuticals GmbH
Study Chair:	Merz Pharmaceuticals	Merz Pharmaceuticals GmbH

More Information

No publications provided

Responsible Party:	Merz Pharmaceuticals GmbH ( Clinical R&D CNS )
Study ID Numbers:	MRZ 60201-0410
Study First Received:	February 7, 2007
Last Updated:	May 11, 2009
ClinicalTrials.gov Identifier:	NCT00432666 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Poland: Office for Registration of Medicinal Products, Medicinal Devices and Biocides

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Neuromuscular Agents
Brain Diseases
Cerebrovascular Disorders

Pharmacologic Actions
Botulinum Toxins
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Peripheral Nervous System Agents
Brain Infarction
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010