NCT03216473

Brief Summary

This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2016

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

10 months

First QC Date

July 12, 2017

Last Update Submit

July 12, 2017

Conditions

Essential Blepharospasm

Outcome Measures

Primary Outcomes (1)

  • JRS (Jankovic Rating Scale) sum-score

    Change from baseline at 4 week for the JRS (Jankovic Rating Scale) sum-score

    From baseline at 4 week

Study Arms (2)

Neuronox

EXPERIMENTAL

Botulinum Toxin Type A for injection

Drug: Neuronox

Botox

ACTIVE COMPARATOR

Botulinum Toxin Type A for injection

Drug: Botox

Interventions

NeuronoxDRUG

Clostridium Botulinum Toxin A 100 U

Also known as: Botulinum Toxin Type A for injection
Neuronox
BotoxDRUG

Clostridium Botulinum Toxin A 100 U

Also known as: Botulinum Toxin Type A for injection
Botox

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 75
  • Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection

You may not qualify if:

  • Subjects who underwent surgical operation
  • Subjects with Neuroleptic induced blepharospasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Benign essential blepharospasm

Interventions

Botulinum Toxins, Type AInjections

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 13, 2017

Study Start

May 25, 2016

Primary Completion

March 17, 2017

Study Completion

July 4, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07