Myofascial Pain SyndromesPhase 2NCT00134810
Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome
A Phase 2 study testing Botulinum toxin type A in people with Myofascial Pain Syndromes, run by Ipsen at 22 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Botulinum toxin type A
- How many people
- 381 participants
- Where
- 22 sitesin 6 countries
- Study dates
- Mar 2005to 18 May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe pain in upper back
- Myofascial pain syndrome for more than 6 months
- Active trigger points in upper back
Who cannot join
- 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
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Germany7 sites
Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
Bochum, 44789
Schmerzzentrum Frankfurt
Frankfurt am Main, 60311
Schmerzzentrum Goppingen
Göppingen, 73033
Klinik fur Anaesthesiologie und Intensivtherapie
Jena, 07747
Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
Kiel, 24149
Clinic for Neurology, Westfalische Wilhelmsuniversitat
Münster, 48129
Aukammallee 33
Wiesbaden, 65191
Spain5 sites
Hospital Univ Germans Trias i Pujol
Badalona, 08916
Hospital de Traumatologia de la Vall d'Hebrón
Barcelona, 08035
Hospedale Clinic I Provincial de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Morales Meseguer
Murcia, 30008
Poland4 sites
Centrum Kliniczno-Badawcze
Elblag, 82300
Osrodek Badan Klinicznych
Lublin, 20022
Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
Torun, 87100
Centrum Medyczne OSTEOMED NZOZ
Warsaw, 02341
Czechia3 sites
Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
Brno, 656 91
Dept Neurology, Teaching Hospital Olomouc
Olomouc, 775 20
Institute of Rheumatology
Prague, 12850
Italy2 sites
Fondazione Salvatore Maugeri
Montescano, 27040
Azienda Ospedaliera di Padova
Padova, 35128
About this study
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
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.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Botulinum toxin type A
- Keywords
- Myofascial pain syndrome
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startMar 2005
- Primary completion18 May 2006
- Study completion18 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134810
- Sponsor's protocol ID
- Y-47-52120-722
- Other IDs
- 2004-001845-13, 2004
- Status last verified
- Nov 2019
- First submitted
- 23 Aug 2005
- Last updated
- 22 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00134810
- Acronym / sponsor ID
- Y-47-52120-722
- Conditions
- Myofascial Pain Syndromes
- Keywords
- Myofascial pain syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- 18 May 2006 (actual)
- Study completion
- 18 May 2006 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate-severe pain in upper back
- Myofascial pain syndrome for more than 6 months
- Active trigger points in upper back
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
Change in pain score for 'overall pain of the day during activity' between baseline and Week 6
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Myofascial Pain Syndromes, run by Ipsen at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Spain, Poland, Czechia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score for 'overall pain of the day during activity' between baseline and Week 6. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.