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 (MPS)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-001845-13-GB
• Date of registration: 15/02/2005
• Prospective Registration: Yes
• Primary sponsor: Beaufour Ipsen Pharma S.A.S.
• Public 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 (MPS)
• Scientific 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 (MPS)
• Date of first enrolment: 15/07/2005
• Target sample size: 340
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001845-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Germany, Italy, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
The patient must present at baseline with pain score of moderate or severe on a 4-point rating scale. Pain score is an overall rating of pain experienced during activity over the 7 days prior to the visit.

The patient must have suffered from upper back, myofascial pain syndrome for more than 6 months.

The patient must present with at least 3 active TrPs in the region of the upper back musculature (excluding upper neck musculature). An active TrP is defined as a tender spot localised in a taut band of muscle fibres associated with tenderness and referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation and, preferably local twitch response at palpation and/or jump sign at palpation (derived from Travell and Simons).

The patients’ pain medication regimen must be stable and within the normal recommended doses on study entry and must remain so until Week 6.

The patient must be aged 18 years or older.

The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The patient suffers from pericranial or upper neck pain, or specific shoulder pain, such as tumours, radicular syndromes, inflammatory processes, age-untypical degenerative changes, infection, clinically manifest prolapse, neurological failure, chronic polyarthritis, collagenosis, Bechterew's disease, disc herniation, nerve root impingement or fibromyalgia.

The patient has suffered from upper back MPS for more than 24 months.

The patient has received surgery on the cervical spine in the last 6 months.

The patient has any mental condition which results in him/her being unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

The patient has received anaesthetic injections to the TrP’s within 1 month prior to study entry.

The patient has received steroid injections for their MPS in the last 3 months.

The patient has a known history of non-responsiveness to botulinum toxin A or has received botulinum toxin A in the last 6 months.

The patient has a known history of hypersensitivity to the investigational drug, its constituents or drugs with a similar mechanism of action.

The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol.

The patient has hypertension that is not adequately controlled by treatment.

The patient has a history of other muscular diseases or diseases of neuromuscular transmission e.g. myasthenia gravis.

The patient has a history of, or current problems with alcohol/drug abuse and/or analgesic overuse/abuse.

The patient is pregnant or lactating. Females of childbearing potential must provide a negative pregnancy test within 7 days prior to the start of the study and must be using oral or injectable contraception. (Non-childbearing potential is defined as post menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study).

The patient has received any other investigational drug within the 30 days prior to study entry.

The patient has abnormal baseline findings considered by the investigator to indicate conditions that might affect the study.

The patient has any other condition that, in the opinion of the investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Upper back myofascial pain syndrome (MPS)
MedDRA version: 7.0 Level: PT Classification code 10048780

Intervention(s)

Trade Name: Dysport
Product Name: Dysport
Product Code: Not applicable
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Powder for injection*
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

Main Objective: To compare the efficacy of a single application of Dysport (100, 300 or 500 units) injected into 3 to 6 trigger points (TPs) located in the upper back musculature of adults with (MPS) with placebo

Primary end point(s): Change in pain score for ‘overall pain of the day during activity’ between baseline and week 6. This pain score is the mean of the individual pain scores recorded each day (evenings) for the 7 days prior to each visit assessed using an 11-point numerical rating scale with the following question, ‘overall pain of the day during activity’.

Secondary Objective: To assess the safety profile of each of the doses of Dysport

Secondary ID(s)

Y-47-52120-722

2004-001845-13-DE