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Neurotoxin
Levator Scapulae for Cervical Dystonia (ASISinCD Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by li nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
•Adults with cervical dystonia, or abnormal head position and neck pain for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ASISinCD Trial Summary
Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
Eligible Conditions
- Cervical Dystonia
- Cervicogenic Headache
ASISinCD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASISinCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Secondary outcome measures
Efficacy of Botox intramuscularly vs. subdermally in Cervical Dystonia.
Other outcome measures
Adverse Reactions of Botox intramuscularly vs. subdermally in Cervical Dystonia.
ASISinCD Trial Design
22Treatment groups
Experimental Treatment
Group I: TrapeziusExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group II: Sterno-cleido-mastoidExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group III: SpleniusExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group IV: SemispinalisExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group V: ScaleneExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group VI: Percent of Patients with Improved PGASExperimental Treatment10 Interventions
Percent of Patients with Improved PGAS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The Physician Global Assessment Scale or PGAS is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from -4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement.
Group VII: LongissimusExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group VIII: Levator ScapulaeExperimental Treatment1 Intervention
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Group IX: Change from Baseline in Pain IntensityExperimental Treatment10 Interventions
Change from Baseline in Pain Intensity as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The severity on scales of 0(no pain) to 4(constant or extremely severe intensity).
Group X: Change from Baseline in Pain FrequencyExperimental Treatment10 Interventions
Change from Baseline in Pain Frequency as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.
Group XI: Change from Baseline in CDSSExperimental Treatment10 Interventions
Change from Baseline in CDSS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The CDSS or Cervical Dystonia Severity Scale quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS allots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54).
Group XII: Adverse Reactions with Neck painExperimental Treatment2 Interventions
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIII: Adverse Reactions with MyalgiaExperimental Treatment2 Interventions
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIV: Adverse Reactions with Muscular weaknessExperimental Treatment2 Interventions
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XV: Adverse Reactions with Muscle stiffnessExperimental Treatment2 Interventions
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVI: Adverse Reactions with Muscle spasmsExperimental Treatment2 Interventions
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVII: Adverse Reactions with Muscle painExperimental Treatment2 Interventions
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XVIII: Adverse Reactions with HypertensionExperimental Treatment2 Interventions
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XIX: Adverse Reactions with Facial paresisExperimental Treatment2 Interventions
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XX: Adverse Reactions with Eyelid ptosisExperimental Treatment2 Interventions
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XXI: Adverse Reactions with BronchitisExperimental Treatment2 Interventions
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Group XXII: Adverse Reactions Injection site painExperimental Treatment2 Interventions
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gadopentetic acid
FDA approved
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Who is running the clinical trial?
li nguyenLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
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