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Dysport (Botulinum Toxin Type A) - Summary

 
 



Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of DYSPORT™ and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

 

DYSPORT SUMMARY

Botulinum toxin type A, the active ingredient in DYSPORT™ (abobotulinumtoxinA), is a purified neurotoxin type A complex produced by fermentation of the bacterium Clostridium botulinum type A, Hall Strain.

Cervical Dystonia

DYSPORT™ (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naive and previously treated patients.

Glabellar Lines

DYSPORT™ (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients <65 years of age.


See all Dysport indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Dysport (Botulinum Toxin Type A)

The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. [2014]
BACKGROUND: Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications...

Correlation of botulinum toxin dose with neurophysiological parameters of efficacy and safety in the glabellar muscles: a double-blind, placebo-controlled, randomized study. [2014]
Despite the extensive use of botulinum toxin type A (BoNT-A) in treatments for glabellar frown lines, the dose-response effect in the glabellar muscles remains unknown. The aim of this randomized, double-blind, placebo-controlled prospective study was to characterize the neurophysiological parameters that correlate with the effect of BoNT-A in the glabellar muscles and its diffusion to surrounding ocular muscles...

Safety and efficacy of botulinum toxin in primary orthostatic tremor. [2013]
Primary orthostatic tremor (POT) is a rapid 13-18 Hertz tremor that produces a subjective feeling of unsteadiness when standing, and is absent when seated or supine. It predominantly affects the legs during isometric contraction though a similar tremor can be seen in the arms and jaw...

OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline. [2013]
Acute headache medication overuse (MO) is common in patients with chronic migraine (CM). We evaluated safety and efficacy of onabotulinumtoxinA as preventive treatment of headache in CM patients with baseline MO (CM+MO) in a planned secondary analysis from two similarly designed, randomized, placebo-controlled, parallel, Phase III trials.

Upper extremity spasticity in children with cerebral palsy: a randomized, double-blind, placebo-controlled study of the short-term outcomes of treatment with botulinum A toxin. [2013]
varying levels of function... CONCLUSIONS: Children receiving BoNT-A injections demonstrated clinically

more studies >>

Clinical Trials Related to Dysport (Botulinum Toxin Type A)

Over Active Bladder Instillation Study - Botox [Recruiting]
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Study Comparing Short Term Efficacy of Dysport� and Dysport RU� to Placebo, and to Assess Efficacy and Safety of Dysport RU� of Subjects With Cervical Dystonia [Recruiting]
The purpose of this study is to evaluate how well a new drug called Dysport RU works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be compared to an approved drug called Dysport.

The Randomized Double-blind Placebo-controlled Trial of Intralesional Botulinum Toxin A Injection for Recalcitrant Alopecia Totalis and Alopecia Universalis [Not yet recruiting]
The main purpose of this study is to determine the efficacy of intralesional botulinum toxin type A injection for recalcitrant alopecia totalis and alopecia universalis.

Treatments of recalcitrant alopecia totalis and universalis remains an challenge issue for medical practice. The application of diphenylcyclopropenone (DPCP) is still being an standard treatment for the condition, however, there are at least thirty percentage of patients recalcitrant to this treatment.

The complete etiology of this disease has yet to be clear. Nevertheless,recent studies have demonstrated the hypothesis of neurotransmitter involvements.

There is numerous evidence in support of an imbalance of transmitters, including substance P and Calcitonin gene-related peptide.

Botulinum toxin A injection has been used to treat a neuralgiform headache and diffused alopecia areata. Both headache and hair loss have been made much in improvement. This data may support the neurotransmitter imbalance theory.

The investigators have been informed about possible effects to the alopecia condition, therefore, this study is conducted to assess the efficacy of botulinum toxin A as the novel treatment for recalcitrant alopecia totalis and alopecia universalis.

Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches [Recruiting]

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines [Recruiting]
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

more trials >>

Reports of Suspected Dysport (Botulinum Toxin Type A) Side Effects

Dysphagia (18)Muscular Weakness (17)Neck Pain (12)Wrong Technique in Drug Usage Process (10)Drug Ineffective (10)Headache (8)Eyelid Ptosis (8)Asthenia (8)Fall (7)Diplopia (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Dysport has an overall score of 5. The effectiveness score is 5 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
 

Dysport review by 43 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   wrinkles
Dosage & duration:   300 units (dosage frequency: one time treatment) for the period of one time treatment
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   I had deepening frown lines on my forehead and between my eyes....the benefits were a decrease of the lines (wrinkles).
Side effects:   I had a mild headache for a couple of days after my injections. Also, my forehead felt "numb" as if I had had a tooth pulled. Now, when I raise my eyebrows, my eyebrows go up and the middle of my forehead stays still. It looks a bit strange.
Comments:   I had 300 units of Dysport injected into my forehead in about 5 different places. I was told to not bend over or lie back for a few hours or touch my forehead after the treatment. I followed my doctors instructions. It has been over a week since the injections and there is still a mild wrinkle between my eyes. The wrinkle is definitely not as deep looking as it was but it is still visible. I would probably have this done again although the results are not perfect.

 

Dysport review by 58 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   brow wrinkles
Dosage & duration:   1-2 viles (dosage frequency: twice) for the period of 4-6 injections each time
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   There was a slight softening of the verticle wrinkles between my eyebrows, or "11" lines, but not the degree of change I was looking for, or had been suggested was possible by my physician, even after the second treatment.
Side effects:   I had severe black eyes and brusing after first round of injections and loss of the eye lid crease in my left eye. The bruising took two weeks to completely clear and the lost lid crease never completely returned to normal so is being monitored by my physician and the manufacturer of the Dysport since this was an unusual outcome.
Comments:   Injections were adminsitered by a board certified opthamologist and plastic surgeon who has specal training with this product and instructs other physiians in its use. She couldnot explain my poor outcome other than to say I had very reisistant muscles and the furrowing was very deep.

See all Dysport reviews / ratings >>

Page last updated: 2014-11-30

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