Study Stopped
The study was terminated early due to slow recruitment.
Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice
NMJ
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
2 other identifiers
interventional
100
4 countries
23
Brief Summary
The aim of the study was to compare Dysport treatment results (as assessed by Modified Ashworth Scale (MAS) in the elbow joint 4 weeks post treatment) following two treatment techniques: the current clinical practice injection technique using high-concentration dilution (300 U/mL Dysport) versus the neuromuscular junction (NMJ)-targeted injection technique using low-concentration dilution (100 U/mL Dysport). The hypothesis was that one high-volume, low-concentration injection located centrally in the area/band of the NMJ zones would be as effective as the technique used in current medical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2012
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
February 18, 2019
CompletedSeptember 27, 2022
September 1, 2022
2.5 years
September 6, 2012
December 28, 2016
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4
A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 4 were considered as responders in the primary efficacy analysis.
Baseline to Week 4
Secondary Outcomes (7)
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 and Week 12
Baseline to Week 12
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the MAS at Week 12
Baseline to Week 12
Change From Baseline of Spasticity Related Pain Measured by Visual Analogue Scale (VAS), Assessed by the Subject
Baseline, Week 4 and Week 12
Injection Site Pain Measured by VAS at Day 1.
Baseline
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS)
Up to Week 12
- +2 more secondary outcomes
Study Arms (2)
NMJ Targeted
EXPERIMENTALNMJ targeted technique and low-concentration dilution (Dysport 100 U/mL). The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Current Clinical Practice
ACTIVE COMPARATORCurrent clinical practice technique and high-concentration dilution (Dysport 300 U/mL). A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent prior to any study related procedures.
- Subjects male or female, aged 18 years 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 in muscle (m.) brachialis, m. biceps brachii, m. brachioradialis, m. flexor carpi ulnaris, m. flexor carpi radialis as the previous treatment cycle.
- Last BoNT-A treatment 12-24 weeks ago.
You may not qualify if:
- Poor response to BoNT-A treatment, according to Investigator.
- Need of Dysport doses \>800 U 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.
- Was likely to start other spasticity treatment during the study.
- Was 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.
- Was at risk of pregnancy or was lactating. Females of childbearing potential must have provided a negative pregnancy test (urinary human chorionic gonadotropin (U-hCG)) at Visit 1 and must have been using adequate contraception. Non-childbearing potential was defined as post-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study.
- Had a history of, or known current, problems with alcohol or drug abuse.
- Had 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (23)
Aalborg Sygehus Nord
Aalborg, 9000, Denmark
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
Regionshospitalet Hammel
Hammel, 8450, Denmark
Bispebjerg Hospital
København NV, 2400, Denmark
Roskilde Hospital
Roskilde, 4000, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Regionshopsitalet Viborg
Viborg, 8800, Denmark
North Karelia Central Hospital
Joensuu, 80210, Finland
Central Hospital of Central Finland
Jyväskylä, 40503, Finland
Haukeland University Hospital
Bergen, 5021, Norway
Sykehuset Telemark HF
Skien, , 3700, Norway
Mälarsjukhuset MSE
Eskilstuna, 631-88, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Hallands Sjukhus, Neurology Clinic
Halmstad, 30185, Sweden
Sundsvall-Härnösand, Rehabilitation Medicine
Härnösand, 87182, Sweden
Nyköpings Lasarett,
Nyköping, 61185, Sweden
Örnsköldsviks Sjukhus, Neurology Clinic
Örnsköldsvik, 891 89, Sweden
Östersunds Rehabilitation Center
Östersund, 83102, Sweden
Neurorehab Sävar
Sävar, 91831, Sweden
Neurology Clinic Stockholm
Stockholm, 114 33, Sweden
Danderyds Hospital,
Stockholm, 18288, Sweden
Rehabilitation Center Gotland
Visby, 62184, Sweden
Ystad Lasarett
Ystad, 27133, Sweden
Related Publications (1)
Rekand T, Biering-Sorensen B, He J, Vilholm OJ, Christensen PB, Ulfarsson T, Belusa R, Strom T, Myrenfors P, Maisonobe P, Dalager T. Botulinum toxin treatment of spasticity targeted to muscle endplates: an international, randomised, evaluator-blinded study comparing two different botulinum toxin injection strategies for the treatment of upper limb spasticity. BMJ Open. 2019 May 5;9(5):e024340. doi: 10.1136/bmjopen-2018-024340.
PMID: 31061021DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to slow recruitment, the study was terminated early. Therefore, fewer subjects than planned were enrolled.
Results Point of Contact
- Title
- Medical Director, Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 10, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 27, 2022
Results First Posted
February 18, 2019
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.