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Blepharospasm Short Interval | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Blepharospasm Short Interval

Prospective, Open-label, Single-arm, Single-center Trial to Investigate the Tolerability of NT 201 and Quality of Life of Patients in the Treatment of Blepharospasm With Shortened Injection Intervals

NCT00507637•Merz Pharmaceuticals GmbH

View on ClinicalTrials.gov

Summary

The objective of this Phase II study is to show that pre-treated patients with BEB with the need of shortened injection intervals achieve an improved and stable quality of life level if they receive repeated NT 201 injections at short injection intervals. In addition, the tolerability of repeated shortened NT 201 administrations in patients with BEB including the development of neutralizing antibodies will be investigated.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles
•Medical need for treatment with shortened injection intervals (\< 12 weeks) confirmed by the patient and investigator
•Blepharospasm Disability Index (BSDI) at baseline visit before injection of \> / = 1,6

Exclusion Criteria

•Atypical variant of blepharospasm caused by inhibition of levator palpebrae muscle (apraxia of the eyelid)
•Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), as well as amyotrophic lateral sclerosis or any other significant neuromuscular disease which might interfere with the trial
•The previous three injections with Botulinum toxin Type A with more than 50 Units \[U\] per eye per injection session
•Treatment with Botulinum toxins for any indication other than BEB within 4 months prior to baseline and during the trial

Locations (1)

Universitaets Augenklinik

Bonn, Germany

Key Dates

Start Date

August 1, 2007

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

February 6, 2012

Enrollment

ACTUAL participants

Conditions

Blepharospasm

Interventions

NT 201

DRUG

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

NCT03938363

Cervical Dystonia, PrimaryBlepharospasm

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COMPLETEDNA

The Role of the Upper Colliculus in the Idiopathic Blepharospasm

NCT03903341

Blepharospasm, Benign Essential

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UNKNOWN

A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Blepharospasm Short Interval

Inclusion Criteria

Exclusion Criteria

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

The Role of the Upper Colliculus in the Idiopathic Blepharospasm

A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome

A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm