Neuro Muscular Junction Study (NMJ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01682148
First received: September 6, 2012
Last updated: September 30, 2014
Last verified: September 2014

September 6, 2012
September 30, 2014
September 2012
September 2016   (final data collection date for primary outcome measure)
Change from baseline for elbow flexors muscle tone as measured by the Modified Ashworth Scale (MAS) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Modified Ashworth Scale (MAS) of elbow flexors [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01682148 on ClinicalTrials.gov Archive Site
  • Change from baseline for elbow flexors muscle tone as measured by the MAS [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline of spasticity related pain measured by Visual Analogue Scale (VAS), assessed by the subject [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    Pain assessment using the VAS. The VAS is a 10-cm straight horizontal line scoring scale. Score range on VAS is from 0 to 10 where zero [0] indicates no pain and 10 indicates worst possible pain imaginable.
  • Injection pain measured by Visual Analogue Scale (VAS), ean change from baseline of spasticity related pain measured by Visual Analogue Scale (VAS), assessed by the subject [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Pain assessment using the VAS. The VAS is a 10-cm straight horizontal line scoring scale. Score range on VAS is from 0 to 10 where zero [0] indicates no pain and 10 indicates worst possible pain imaginable.
  • Achievement of the primary goal measured by Goal Attainment Scale (GAS) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    At baseline, the investigator will interview the subject to identify the main problem area and establish an agreed primary goal related to elbow flexion to be followed up at week 4 or 12 depending on the time point defined at the baseline visit.
  • Subject global evaluation of treatment effect [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
    Comparison of treatment effect between previous (pre study) and study treatment cycles assessed by the subject at the end of study (visit 3 or 4). Categorised as follows: Much worse / Worse / Same / Better / Much better.
  • Investigator preference of injection technique [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for elbow flexors muscle tone as measured by the MAS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline for wrist flexors muscle tone as measured by the MAS [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Change from baseline of elbow flexors and wrist flexors combined as measured by the MAS [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline of spasticity related pain measured by Visual Analogue Scale (VAS), assessed by the subject [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Injection pain measured by Visual Analogue Scale (VAS) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Achievement of the primary goal measured by Goal Attainment Scale (GAS) [ Time Frame: Week 4 or 12 ] [ Designated as safety issue: No ]
  • Subject global evaluation of treatment effect [ Time Frame: Week 12 or 24 (at the latest) ] [ Designated as safety issue: No ]
    Categorised as follows: Much worse / Worse / Same / Better / Much better.
  • Investigator preference of injection technique [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Neuro Muscular Junction Study
A Phase III Prospective, Multi-center, Randomised, Evaluator-blinded Study to Compare Neuromuscular Junction (NMJ) Targeted Technique for Dysport® Injections in Upper Limb Spasticity Post Stroke or Traumatic Brain Injury to the Technique Used in Current Clinical Practice

The aim of this study is to compare Dysport treatment results after current clinical practice injection technique and high-concentration dilution to the neuromuscular junction targeted injection technique and low-concentration dilution in the elbow joint assessed by Modified Ashworth Scale 4 weeks post treatment. The hypothesis is that one high volume injection centrally located in the area/band of the NMJ zones will be as effective as the technique used today in current medical practice.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Arm Spasticity
  • Procedure: Current clinical practice technique and high-concentration dilution
    The same number and sites of injections/deposits per muscle will be given as pre study. With a Dysport dilution of 300U/mL the volume to be injected will vary in the interval of 0.1 mL to 0.7 mL per muscle.
  • Procedure: NMJ targeted technique and low-concentration dilution
    A single injection per muscle will be given in the midline of the band of NMJ zones. With a Dysport dilution of 100U/mL the volume to be injected will vary in the interval of 0.4 mL to 2.0 mL per muscle.
  • Active Comparator: Group 1
    Current clinical practice technique and high-concentration dilution
    Intervention: Procedure: Current clinical practice technique and high-concentration dilution
  • Experimental: Group 2
    NMJ targeted technique and low-concentration dilution
    Intervention: Procedure: NMJ targeted technique and low-concentration dilution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
272
September 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provision of written informed consent prior to any study related procedures
  • Subjects male or female, aged 18 or older
  • Upper limb spasticity post stroke or traumatic brain injury
  • Spasticity position pattern type 1, 3 or 4
  • Elbow flexor muscles spasticity MAS 2 to 3
  • At least 2 consecutive previous treatment cycles of BoNT-A for current diagnosis
  • The latest treatment cycle demonstrating good treatment efficacy where the Dysport dose administered was considered to be adequate according to Investigator judgement
  • Need of the same treatment modality as the previous treatment cycle,
  • Last BoNT-A treatment 12-24 weeks ago

Exclusion Criteria:

  • Poor response to BoNT-A treatment, according to Investigator
  • Need of Dysport doses >800U in the upper limb
  • Concomitant treatment with BoNT-A for other indications than spasticity
  • Any elbow flexor contracture prohibiting MAS evaluation and/or elbow flexion improvement of at least 1 step on the MAS
  • Cutaneous or joint inflammation in the affected upper limb
  • Is likely to start other spasticity treatment during the study
  • Is likely to start physiotherapy treatment during the study
  • Other ongoing neurological disorder (e.g., myasthenia gravis)
  • History of dysphagia or aspiration
  • Use of agents interfering with neuromuscular transmission (e.g., aminoglycosides)
  • Treated with an investigational medicinal product within 30 days before start of the study
  • Known sensitivity to BoNT-A or any components of Dysport,
  • Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test (U-hCG) at visit 1 and must be using adequate contraception. Non childbearing potential is defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study,
  • Has a history of, or known current, problems with alcohol or drug abuse,
  • Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude,
  • Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Both
18 Years and older
No
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Denmark,   Finland,   Sweden,   Norway
 
NCT01682148
A-99-52120-162, 2011-005375-16
No
Ipsen
Ipsen
Not Provided
Study Director: Peter Myrenfors Ipsen
Ipsen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP