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Dysport vs Botox for Upper Limb Spasticity (DIRECTION Trial)
DIRECTION Trial Summary
This trial is testing if a new botulinum toxin is non-inferior to the current standard botulinum toxin in safety and if it is superior in efficacy.
DIRECTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDIRECTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DIRECTION Trial Design
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Who is running the clinical trial?
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- I haven't had surgery or specific treatments on my limb in the last 6 months.I have not responded to Botox treatments in the past.I don't have any health issues that could make this trial unsafe for me.I have never used BoNT-A for upper limb spasticity, or I have used it before.I have never received Botox for my facial nerve disorder.I have an infection where I might get an injection.I need Botox injections in certain muscles.I am not pregnant or breastfeeding.I have not received Botox treatment in the last 12 weeks and do not plan to during the study.You are allergic to cow's milk protein.I have significant movement restrictions in my affected arm.I have a condition affecting my nerves or muscles, like ALS or myasthenia gravis.You have muscle weakness in at least two muscle groups, with one of them being the PTMG.My arm has been stiff for over 3 months and needs treatment.I have not taken certain medications recently or plan to during the study.My medication for muscle stiffness, blood thinning, or dry mouth has been stable for 3 months.I have had stable upper limb issues for 3 months after a stroke and need treatment for one arm.You are allergic to any BoNT product or its ingredients.I do not have major brain or nerve problems affecting my daily activities.I need injections in muscles not listed in the study or in both arms/legs during the study.I am getting specific physical or occupational therapy for my study limb while on medication.I am between 18 and 80 years old.I have difficulty with dressing, hygiene, moving, or pain.I am considered suitable for a specific dose of Botox treatment.I have never used or have previously used Botulinum toxin type A for upper limb spasticity.
- Group 1: Sequence 1
- Group 2: Sequence 2
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age range for participants in this trial inclusive of those aged sixty-five years and above?
"Eligibility for this study is restricted to individuals aged 18 - 75. On the other hand, there are 25 trials available for minors and 107 options open to those over 65."
Are there any opportunities to join this clinical experiment at the present time?
"Affirmative. The clinical trial's page on clinicaltrials.gov attests that this medical research is currently seeking enrolment from participants, with the original post date of June 23rd 2021 and most recent edit being on December 1st 2022. To complete the study, 564 patients need to be recruited across 54 sites."
Has the FDA sanctioned this treatment?
"As this treatment has been approved and is in its fourth clinical trial, it was given a ranking of 3 for safety."
Is there a substantial presence of this research study in Canada?
"The current trial enrolling patients is found at 54 distinct sites, including Stony Brook and Nashville. For the sake of convenience, it's best to choose a location close by in order to minimize travel requirements."
What are the eligibility requirements to partake in this clinical experiment?
"This clinical trial is enrolling 564 individuals who have been diagnosed with spasticity and are aged between 18-75. To qualify, applicants must meet the following requirements: Be within the specified age range at time of signing informed consent; Stable Upper Limb Spasticity (ULS) for 3 months or post-stroke ULS in Canada; Naive to Botulinum toxin type A (BoNT-A); MAS score of 2+ on elbow, wrist & finger flexors; DAS score of 2+ on Principal Target Treatment (PTT); Requiring BoNT-A injection into designated muscles; 900 Units"
Have any other trials been conducted on this therapeutic agent?
"The effects of this medication were initially evaluated by the Rothman Institute in 2012, and to date 460 studies have been successfully completed. Presently there are 61 active experiments; prominent among them is a trial taking place at Stony Brook University in New york."
How many individuals are being enrolled in this scientific experiment?
"Affirmative. Information available on clinicaltrials.gov makes clear that this experiment began the recruitment process on June 23rd 2021 and is still actively searching for participants. The trial requires 564 people to be enrolled from 54 distinct sites in order to proceed as planned."
What condition is this treatment primarily employed to address?
"This treatment has proven to be useful in treating urinary incontinence, as well as other medical issues including spinal cord damage, botox injections and OABs."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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