NCT01588574

Brief Summary

The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 8, 2014

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

April 24, 2012

Last Update Submit

September 5, 2014

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    Day 30

Study Arms (2)

BOTOX (registered trade mark)

ACTIVE COMPARATOR
Biological: BOTOX(Registered trade mark)

MT10109

EXPERIMENTAL
Biological: MT10109

Interventions

MT10109BIOLOGICAL

Botulinum toxin type A

MT10109
BOTOX(Registered trade mark)BIOLOGICAL

Botulinum toxin type A

BOTOX (registered trade mark)

Eligibility Criteria

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

You may qualify if:

  • Male or female aged 18\~75
  • Have no clinically significant medical condition
  • Cervical dystonia

You may not qualify if:

  • Pregnant or lactation
  • Subjects who have been administered the following drugs within the previous 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brisbane, Australia

Location

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

May 1, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

September 8, 2014

Record last verified: 2013-02

Locations

AU(1)