Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

NCT ID: NCT00134810

Last Updated: 2019-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-18

Brief Summary

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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.

Detailed Description

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Conditions

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Myofascial Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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

Brno, , Czechia

Site Status

Dept Neurology, Teaching Hospital Olomouc

Olomouc, , Czechia

Site Status

Institute of Rheumatology

Prague, , Czechia

Site Status

Neurology Clinic, Klinikum der Ruhr-Universitat Bochum

Bochum, , Germany

Site Status

Schmerzzentrum Frankfurt

Frankfurt am Main, , Germany

Site Status

Schmerzzentrum Goppingen

Göppingen, , Germany

Site Status

Klinik fur Anaesthesiologie und Intensivtherapie

Jena, , Germany

Site Status

Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel

Kiel, , Germany

Site Status

Clinic for Neurology, Westfalische Wilhelmsuniversitat

Münster, , Germany

Site Status

Aukammallee 33

Wiesbaden, , Germany

Site Status

Fondazione Salvatore Maugeri

Montescano, , Italy

Site Status

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status

Centrum Kliniczno-Badawcze

Elblag, , Poland

Site Status

Osrodek Badan Klinicznych

Lublin, , Poland

Site Status

Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy

Torun, , Poland

Site Status

Centrum Medyczne OSTEOMED NZOZ

Warsaw, , Poland

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Hospital Univ Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital de Traumatologia de la Vall d'Hebrón

Barcelona, , Spain

Site Status

Hospedale Clinic I Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Hospital Morales Meseguer

Murcia, , Spain

Site Status

Countries

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Czechia Germany Italy Poland Portugal Spain

Other Identifiers

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2004-001845-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Y-47-52120-722

Identifier Type: -

Identifier Source: org_study_id

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