NCT00950664

Brief Summary

  1. 1.to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
  2. 2.double blind, randomised, multi center, crossover study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

7 active sites

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

July 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 11, 2013

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

July 29, 2009

Results QC Date

February 8, 2013

Last Update Submit

June 13, 2017

Conditions

Cervical Dystonia

Keywords

cervical dystoniabotulinum toxin

Outcome Measures

Primary Outcomes (1)

  • Reduction of Total Tsui Score at 4 Weeks From Baseline

    Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor. Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.

    4 weeks after injection from baseline

Secondary Outcomes (3)

  • Reduction of Total TWSTRS Score at 4 Weeks From Baseline

    4 weeks after injection from baseline

  • CGI-I (Clinical Global Impression of Illness)

    4, 8, 12 and 16 weeks after injection

  • PGI-I (Patient's Global Impression of Improvement)

    4, 8, 12 and 16 weeks after injection

Other Outcomes (3)

  • Reduction of Tsui Score at Each Visit From Baseline

    8, 12 and 16 weeks after injection

  • Reduction of Total TWSTRS at Each Visit From Baseline

    8, 12 and 16 weeks after injection

  • Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline

    4, 8, 12 and 16 weeks after injection

Study Arms (2)

Dysport® to Botox®

EXPERIMENTAL

Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Drug: Dysport® (abobotulinumtoxinA)Drug: Botox® (onabotulinumtoxinA)

Botox® to Dysport®

EXPERIMENTAL

Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)

Drug: Dysport® (abobotulinumtoxinA)Drug: Botox® (onabotulinumtoxinA)

Interventions

Dysport® (abobotulinumtoxinA)DRUG

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Also known as: Dysport® (abobotulinumtoxinA)injection
Botox® to Dysport®Dysport® to Botox®
Botox® (onabotulinumtoxinA)DRUG

Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Also known as: Botox® (onabotulinumtoxinA)injection
Botox® to Dysport®Dysport® to Botox®

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years of age of both genders,
  • Cervical dystonia
  • symptoms with a minimum duration of 18 months,
  • Negative pregnancy test in sexually active women,
  • Able to participate in the study (understand goals of botulinum toxin A treatment and sign Informed Consent Form).

You may not qualify if:

  • Patient with cervical contractures
  • Known significant underlying dysphasia
  • Patients who have received botulinum toxin treatment within the past 4 months.
  • Contraindication to botulinum toxin treatment
  • Any disease that might affect neuromuscular function (Myasthenia Gravis, Eaton-Lambert syndrome, ALS …)
  • Patients who have received oral anti-spasticity medication, phenol therapy, myotomy or denervation surgery, deep brain stimulation for cervical dystonia,
  • Patients who required more than 500 units of Dysport or 200 units of Botox.
  • Any concomitant treatment that could interfere with the action of botulinum toxin,
  • Subjects having participated within the last 3 months or currently participating in an investigational drug study,
  • Pregnancy,
  • Lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bundang Seoul Natiuonal University Hospital

Seongnam-si, Gyeonggi-do, 463-070, South Korea

Location

Dong-A University Hospital

Busan, 602-715, South Korea

Location

Hanyang University Hospital

Seoul, 133-792, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Boramae City Hospital

Seoul, 156-707, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Yun JY, Kim JW, Kim HT, Chung SJ, Kim JM, Cho JW, Lee JY, Lee HN, You S, Oh E, Jeong H, Kim YE, Kim HJ, Lee WY, Jeon BS. Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study. Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.

    PMID: 25476727DERIVED

MeSH Terms

Conditions

Torticollis

Interventions

abobotulinumtoxinABotulinum Toxins, Type A

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
BS Jeon
Organization
Seoul National University Hospital
brain@snu.ac.kr
+82220722876

Study Officials

  • Beom S Jeon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2009

First Posted

August 3, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

July 1, 2011

Last Updated

July 5, 2017

Results First Posted

October 11, 2013

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(7)