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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001845-13 | EudraCT Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score for 'overall pain of the day during activity' between baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital | Brno | 656 91 | Czechia | |||
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| 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 |
| Dept Neurology, Teaching Hospital Olomouc |
| Olomouc |
| 775 20 |
| Czechia |
| Institute of Rheumatology | Prague | 12850 | Czechia |
| Neurology Clinic, Klinikum der Ruhr-Universitat Bochum | Bochum | 44789 | Germany |
| Schmerzzentrum Frankfurt | Frankfurt am Main | 60311 | Germany |
| Schmerzzentrum Goppingen | Göppingen | 73033 | Germany |
| Klinik fur Anaesthesiologie und Intensivtherapie | Jena | 07747 | Germany |
| Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel | Kiel | 24149 | Germany |
| Clinic for Neurology, Westfalische Wilhelmsuniversitat | Münster | 48129 | Germany |
| Aukammallee 33 | Wiesbaden | 65191 | Germany |
| Fondazione Salvatore Maugeri | Montescano | 27040 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Centrum Kliniczno-Badawcze | Elblag | 82300 | Poland |
| Osrodek Badan Klinicznych | Lublin | 20022 | Poland |
| Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy | Torun | 87100 | Poland |
| Centrum Medyczne OSTEOMED NZOZ | Warsaw | 02341 | Poland |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Univ Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital de Traumatologia de la Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospedale Clinic I Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Morales Meseguer | Murcia | 30008 | Spain |
| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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