NT 201 Versus Placebo in the Treatment of Cervical Dystonia - Full Text View

NT 201 Versus Placebo in the Treatment of Cervical Dystonia

This study is ongoing, but not recruiting participants.

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00407030

Purpose

At baseline patients receive NT 201 or placebo. Thereafter all patients are treated with one of two doses NT 201 during the extension period.

Condition	Intervention	Phase
Cervical Dystonia	Drug: Botulinum Neurotoxin Type A (NT 201)	Phase III

Genetics Home Reference related topics:

early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics:

Dystonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Prospective, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Trial With a Double-Blind Parallel-Group Extension Period to Investigate the Efficacy and Safety of Different Doses of NT 201 in the Treatment of Cervical Dystonia

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:

200

Eligibility

Criteria

Inclusion Criteria:

main inclusion criterion: You must have cervical dystonia (i.e. spasmodic torticollis) and a need for injection with Botulinum toxin.

Exclusion Criteria:

main exclusion criterion: Your cervical dystonia must not have its origin from accidents (traumatic torticollis) or from medicines taken (tardive torticollis).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407030

Locations

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

Study ID Numbers:	MRZ 60201-0408
First Received:	November 30, 2006
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00407030
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dystonic Disorders

Signs and Symptoms

Torticollis

Movement Disorders

Central Nervous System Diseases

Neurologic Manifestations

Dystonia

Dyskinesias

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008