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

NT 201 Versus Placebo in the Treatment of Blepharospasm

This study is ongoing, but not recruiting participants.

Sponsored by:	Merz Pharmaceuticals GmbH
Information provided by:	Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:	NCT00406367

Purpose

Patients receive one injection with NT 201 or placebo before study. Thereafter all patients will receive several injections of NT 201 during the extension period.

Condition	Intervention	Phase
Blepharospasm	Drug: Botulinum neurotoxin type A (NT 201)	Phase III

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 an Open-Label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Blepharospasm

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:

Jankovic Rating Scale

Secondary Outcome Measures:

Jankovic Rating Scale subscores

Estimated Enrollment:

100

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

main inclusion criterion: You must have blepharospasm and a need for injection of Botulinum toxin.

Exclusion Criteria:

main exclusion criterion: Your blepharospasm must not have its origin from a atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle or from medicines taken (tardive blepharospasm).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406367

Locations


United States, Ohio

	Columbus, Ohio, United States

Canada, Nova Scotia

	Halifax, Nova Scotia, Canada

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

More Information

Study ID Numbers:	MRZ 60201-0433
First Received:	November 30, 2006
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00406367
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Benign essential blepharospasm

Eye Diseases

Blepharospasm

Additional relevant MeSH terms:

Eyelid Diseases

ClinicalTrials.gov processed this record on October 20, 2008