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

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00134810

Purpose

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.

Condition	Intervention	Phase
Myofascial Pain Syndromes	Drug: Botulinum type A toxin (Dysport®)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase II Multicentre Multinational Prospective Randomised Double-Blind Placebo-Controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients With Upper Back Myofascial Pain Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Botox Fibromyalgia

Drug Information available for: Botulinum toxin A

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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
Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline
Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
Patient’s Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16

Estimated Enrollment:	340
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134810

Locations

Czech Republic
Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
Brno, Czech Republic, 656 91
Dept Neurology, Teaching Hospital Olomouc
Olomouc, Czech Republic, 775 20
Institute of Rheumatology
Praha, Czech Republic, 12850
Germany
Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
Bochum, Germany, 44789
Schmerzzentrum Frankfurt
Frankfurt am Main, Germany, 60311
Schmerzzentrum Goppingen
Goppingen, Germany, 73033
Klinik fur Anaesthesiologie und Intensivtherapie
Jena, Germany, 07747
Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
Kiel, Germany, 24149
Clinic for Neurology, Westfalische Wilhelmsuniversitat
Munster, Germany, 48129
Aukammallee 33
Wiesbaden, Germany, 65191
Italy
Fondazione Salvatore Maugeri
Montescano, Italy, 27040
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Poland
Centrum Kliniczno-Badawcze
Elblag, Poland, 82300
Osrodek Badan Klinicznych
Lublin, Poland, 20022
Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
Torun, Poland, 87100
Centrum Medyczne OSTEOMED NZOZ
Warsaw, Poland, 02341
Portugal
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Spain
Hospital Univ Germans Trias i Pujol
Badalona, Spain, 08916
Hospedale Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de Traumatologia de la Vall d'Hebrón
Barcelona, Spain, 08035
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Morales Meseguer
Murcia, Spain, 30008

Sponsors and Collaborators

Ipsen

Investigators

Principal Investigator:

Harmut Goebel, MD

Kiel Neurological Pain Centre

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00134810 History of Changes
Other Study ID Numbers:	Y-47-52120-722
Study First Received:	August 23, 2005
Last Updated:	January 9, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Ministry of Health; Poland: Ministry of Health; Italy: Ministry of Health; Czech Republic: State Institute for Drug Control; Portugal: National Pharmacy and Medicines Institute

Keywords provided by Ipsen:

Myofascial pain syndrome

Additional relevant MeSH terms:

Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

Nervous System Diseases
Mental Disorders
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012