Neuro Muscular Junction Study (NMJ)

This study has been terminated.
(The study was terminated early due to slow recruitment.)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01682148
First received: September 6, 2012
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Arm Spasticity
Procedure: Current clinical practice technique and high-concentration dilution
Procedure: NMJ targeted technique and low-concentration dilution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: September 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Current clinical practice technique and high-concentration dilution
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.
Experimental: Group 2
NMJ targeted technique and low-concentration dilution
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682148

Locations
Denmark
Aalborg Sygehus Nord
Aalborg, Denmark, 9000
Glostrup Hospital
Glostrup, Denmark, 2600
Regionshospitalet Hammel
Hammel, Denmark, 8450
Bispebjerg Hospital
København NV, Denmark, 2400
Roskilde Hospital
Roskilde, Denmark, 4000
Vejle Hospital
Vejle, Denmark, 7100
Regionshopsitalet Viborg
Viborg, Denmark, 8800
Finland
North Karelia Central Hospital
Joensuu, Finland, 80210
Central Hospital of Central Finland
Jyväskylä, Finland, 40503
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sykehuset Telemark HF
Skien, Norway, , 3700
Sweden
Mälarsjukhuset MSE
Eskilstuna, Sweden, 631-88
Sahlgrenska University Hospital
Göteborg, Sweden
Hallands Sjukhus, Neurology Clinic
Halmstad, Sweden, 30185
Sundsvall-Härnösand, Rehabilitation Medicine
Härnösand, Sweden, 87182
Nyköpings Lasarett,
Nyköping, Sweden, 61185
Neurology Clinic Stockholm
Stockholm, Sweden, 114 33
Danderyds Hospital,
Stockholm, Sweden, 18288
Neurorehab Sävar
Sävar, Sweden, 91831
Rehabilitation Center Gotland
Visby, Sweden, 62184
Ystad Lasarett
Ystad, Sweden, 27133
Örnsköldsviks Sjukhus, Neurology Clinic
Örnsköldsvik, Sweden, 891 89
Östersunds Rehabilitation Center
Östersund, Sweden, 83102
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Peter Myrenfors Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01682148     History of Changes
Other Study ID Numbers: A-99-52120-162, 2011-005375-16
Study First Received: September 6, 2012
Last Updated: April 28, 2015
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 05, 2015