MedDataX Logo

Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm

NCT ID: NCT00761592

Last Updated: 2013-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blepharospasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A 900kDa

Intervention Type BIOLOGICAL

6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

2

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A 150kDa

Intervention Type BIOLOGICAL

6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum Toxin Type A 900kDa

6 to 16 injections, with maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Intervention Type BIOLOGICAL

Botulinum Toxin Type A 150kDa

6 to 16 injections, with a maximum of 21, at a dose of ≥20U/eye (≥40U total dose)

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BOTOX® Xeomin®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with benign essential blepharospasm
* Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
* Combined Jankovic Rating Score of \>2

Exclusion Criteria

* Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
* Profound atrophy of the muscles in the target area(s) of injection.
* Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
* Known significantly impaired renal and/or hepatic function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bonn, , Germany

Site Status

Wiesbaden, , Germany

Site Status

Zwickau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALLBL001

Identifier Type: -

Identifier Source: org_study_id