Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice (NMJ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01682148|
Recruitment Status : Terminated (The study was terminated early due to slow recruitment.)
First Posted : September 10, 2012
Results First Posted : February 18, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arm Spasticity||Biological: Botulinum toxin type A||Phase 3|
This was a randomised, evaluator-blinded, comparative, parallel group, multicentre study, conducted in four countries (Denmark, Finland, Norway and Sweden). For each subject, the primary efficacy assessments using MAS were performed by the same blinded evaluator, and every effort was made at each site to ensure that the MAS evaluator was the same person throughout the study. Dysport doses were to follow clinical practice for subjects suffering from upper limb spasticity position pattern type 1, 3 or 4 post stroke or traumatic brain injury.
The hypothesis for this study was that one low-concentration botulinum neurotoxin type A (BoNT-A) injection per muscle, centrally located in the area/band of the NMJ zones, would spread to and block the surrounding NMJ zones and be as effective as the technique used today in clinical practice. The possibility to reduce the number of injection points would decrease the risk of injection discomfort, pain and injection site bleeding for the patient. A simplified injection technique with one injection per muscle and in a defined location would also benefit physicians.
At Baseline (Visit 1), subjects were randomised to one of two treatment groups:
- Group 1: Current clinical practice technique and high-concentration dilution: Dysport 300 U/mL.
- Group 2: NMJ targeted technique and low-concentration dilution: Dysport 100 U/mL.
Each subject visited the clinic on at least three occasions:
- Baseline (Visit 1): Screening, randomisation and Dysport treatment.
- Week 4 (Visit 2): Treatment follow-up, 4 weeks after Dysport treatment.
- Week 12 (Visit 3): Treatment and study follow-up, 12 weeks after Dysport treatment.
For subjects not receiving any post study BoNT-A injection at Week 12 due to remaining treatment effect, an extra visit (Visit 4) for study follow-up was to take place at the next routine visit planned for a new BoNT-A injection, at the latest 24 weeks post study injection.
The duration of each subject's study period was at a minimum 12 weeks and maximum 24 weeks. The overall duration of the study was planned to be approximately 36 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: NMJ Targeted
NMJ 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.
Biological: Botulinum toxin type A
Other Name: AbobotulinumtoxinA (Dysport®)
Active Comparator: Current Clinical Practice
Current 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.
Biological: Botulinum toxin type A
Other Name: AbobotulinumtoxinA (Dysport®)
- Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 [ Time Frame: Baseline to 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.
- Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 and Week 12 [ Time Frame: Baseline to Week 12 ]Increased muscle tone in elbow flexors was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
- Change From Baseline for Elbow Flexors Muscle Tone as Measured by the MAS at Week 12 [ Time Frame: Baseline to Week 12 ]A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 12 were considered as responders.
- Change From Baseline of Spasticity Related Pain Measured by Visual Analogue Scale (VAS), Assessed by the Subject [ Time Frame: Baseline, Week 4 and Week 12 ]Pain assessment using the VAS. The VAS was a 10 cm straight horizontal line scoring scale. Score range on VAS was from 0 to 10 where 0 indicated no pain and 10 indicated worst pain imaginable.
- Injection Site Pain Measured by VAS at Day 1. [ Time Frame: Baseline ]Pain assessment using the VAS. The VAS was a 100 mm straight horizontal line scoring scale. Score range on VAS was from 0 to 100 where 0 indicated no pain and 100 indicated worst pain imaginable.
- Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) [ Time Frame: Up to Week 12 ]At Baseline, an agreed primary goal related to elbow flexion in one of the following categories was determined: active function, impairment, involuntary movement, mobility, pain passive function or other. Each goal was usually rated -1, unless the subject was as bad as he/she could be in that particular goal area, in which case the Baseline score was -2. The evaluator rated the outcome score at Week 4 or Week 12, depending on the time point defined at the baseline visit (Visit 1), using the GAS five-point scale (-2, -1, 0, +1 and +2).
- Subject Global Evaluation of Treatment Effect [ Time Frame: Up to Week 24 ]Comparison of treatment effect between previous (prestudy) and study treatment cycles assessed by the subject at the end of study (Week 12 up to Week 24 (Visit 3 or Visit 4)). Categorised as follows: Much worse / Worse / Same / Better / Much better.
- Investigator Preference of Injection Technique [ Time Frame: Following last visit of the last subject at each site ]When all patients at the site had completed the study (last subject last visit) a global assessment of the injection technique was to be made by the Investigators. The following question was answered: "Based on your experience during this study, which injection technique do you prefer?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682148
|Aalborg Sygehus Nord|
|Aalborg, Denmark, 9000|
|Glostrup, Denmark, 2600|
|Hammel, Denmark, 8450|
|København NV, Denmark, 2400|
|Roskilde, Denmark, 4000|
|Vejle, Denmark, 7100|
|Viborg, Denmark, 8800|
|North Karelia Central Hospital|
|Joensuu, Finland, 80210|
|Central Hospital of Central Finland|
|Jyväskylä, Finland, 40503|
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Sykehuset Telemark HF|
|Skien, Norway, , 3700|
|Eskilstuna, Sweden, 631-88|
|Sahlgrenska University Hospital|
|Hallands Sjukhus, Neurology Clinic|
|Halmstad, Sweden, 30185|
|Sundsvall-Härnösand, Rehabilitation Medicine|
|Härnösand, Sweden, 87182|
|Nyköping, Sweden, 61185|
|Neurology Clinic Stockholm|
|Stockholm, Sweden, 114 33|
|Stockholm, Sweden, 18288|
|Sävar, Sweden, 91831|
|Rehabilitation Center Gotland|
|Visby, Sweden, 62184|
|Ystad, Sweden, 27133|
|Örnsköldsviks Sjukhus, Neurology Clinic|
|Örnsköldsvik, Sweden, 891 89|
|Östersunds Rehabilitation Center|
|Östersund, Sweden, 83102|
|Study Director:||Ipsen Medical Director||Ipsen|