NCT00134810

Brief Summary

The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
6 countries

22 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

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2006

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

August 23, 2005

Last Update Submit

November 21, 2019

Conditions

Myofascial Pain Syndromes

Keywords

Myofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in pain score for 'overall pain of the day during activity' between baseline and Week 6

Secondary Outcomes (9)

  • Change in pain score for 'worst pain of the day during activity' between baseline and Week 6

  • Change in pain score for 'overall pain of the day at rest' between baseline and Week 6

  • Spontaneously reported adverse events and changes in physical examination and vital signs

  • Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16

  • Time to onset of pain relief

  • +4 more secondary outcomes

Interventions

Botulinum toxin type ABIOLOGICAL
Also known as: AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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

You may qualify if:

  • Moderate-severe pain in upper back
  • Myofascial pain syndrome for more than 6 months
  • Active trigger points in upper back

You may not qualify if:

  • Fibromyalgia and other non-myofascial pain conditions of upper back
  • Duration of myofascial pain syndrome no longer than 24 months
  • Steroid injections during previous 3 months
  • Anaesthetic injection at trigger points during previous 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital

Brno, 656 91, Czechia

Location

Dept Neurology, Teaching Hospital Olomouc

Olomouc, 775 20, Czechia

Location

Institute of Rheumatology

Prague, 12850, Czechia

Location

Neurology Clinic, Klinikum der Ruhr-Universitat Bochum

Bochum, 44789, Germany

Location

Schmerzzentrum Frankfurt

Frankfurt am Main, 60311, Germany

Location

Schmerzzentrum Goppingen

Göppingen, 73033, Germany

Location

Klinik fur Anaesthesiologie und Intensivtherapie

Jena, 07747, Germany

Location

Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel

Kiel, 24149, Germany

Location

Clinic for Neurology, Westfalische Wilhelmsuniversitat

Münster, 48129, Germany

Location

Aukammallee 33

Wiesbaden, 65191, Germany

Location

Fondazione Salvatore Maugeri

Montescano, 27040, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Centrum Kliniczno-Badawcze

Elblag, 82300, Poland

Location

Osrodek Badan Klinicznych

Lublin, 20022, Poland

Location

Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy

Torun, 87100, Poland

Location

Centrum Medyczne OSTEOMED NZOZ

Warsaw, 02341, Poland

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Univ Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital de Traumatologia de la Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospedale Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Morales Meseguer

Murcia, 30008, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

March 1, 2005

Primary Completion

May 18, 2006

Study Completion

May 18, 2006

Last Updated

November 22, 2019

Record last verified: 2019-11

Locations

DE(7)PT(1)CZ(3)PL(4)IT(2)ES(5)