ASIS for Botox in Cervical Dystonia (ASISinCD)

L

li nguyen

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Cervical Dystonia Adults ,
Abnormal Head Position and Neck Pain for These 7 Muscle Groups: Splenius,Scalene,Sterno-cleido-mastoid,Levator Scapulae,Semispinalis,Trapezius,and Longissimus.

Treatments

Drug: Adverse Reactions of Botox subdermally
Drug: Adverse Reactions of Botox intramuscularly
Drug: Efficacy of Botox subdermally at Week 12
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 30
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Gadolinium
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox intramuscularly at Week 6

Study type

Interventional

Funder types

Industry

Identifiers

NCT02074293
NCTNS089268
R44NS089268 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Cervical Dystonia. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Cervical Dystonia, and these particular 7 muscle groups. Case in point, patients with Cervical Dystonia presumably have hyperactive Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus muscles, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Cervical Dystonia patients will not be like those of normal patients, or even the same between these 7 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2. Aim 2 over 12 months, using Botox, instead of Gadolinium, will demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Cervical Dystonia, on these particular 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Cervical Dystonia somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of improvement on the Physician Global Assessment Scale at 6, 12, 18, 24, and 30 weeks, and reduction in Cervical Dystonia Severity Scale (CDSS) as well as adverse reactions.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

•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.

Exclusion criteria

  • Known Hypersensitivity to Botulinum Toxin or to any of the components in the formulation.
  • Infection at the Injection Site(s).
  • Has any medical condition that may increase their risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
  • Has profound atrophy or weakness of muscles in the target areas of injection.
  • Had previously received surgical or other denervation treatment for their symptoms or had a known history of neuromuscular disorder.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 22 patient groups

Splenius
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Scalene
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Sterno-cleido-mastoid
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Levator Scapulae
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Semispinalis
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Trapezius
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Longissimus
Experimental group
Description:
Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Treatment:
Drug: Gadolinium
Change from Baseline in Pain Frequency
Experimental group
Description:
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.
Treatment:
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 30
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 12
Change from Baseline in Pain Intensity
Experimental group
Description:
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).
Treatment:
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 30
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 12
Change from Baseline in CDSS
Experimental group
Description:
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).
Treatment:
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 30
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 12
Percent of Patients with Improved PGAS
Experimental group
Description:
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.
Treatment:
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 30
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 12
Adverse Reactions with Facial paresis
Experimental group
Description:
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Eyelid ptosis
Experimental group
Description:
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Bronchitis
Experimental group
Description:
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Neck pain
Experimental group
Description:
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Muscle stiffness
Experimental group
Description:
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Muscular weakness
Experimental group
Description:
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Myalgia
Experimental group
Description:
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Muscle pain
Experimental group
Description:
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Muscle spasms
Experimental group
Description:
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions Injection site pain
Experimental group
Description:
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions with Hypertension
Experimental group
Description:
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Treatment:
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally

Trial contacts and locations

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Central trial contact

Thanh Phung, MD; Li Nguyen, MD

Data sourced from clinicaltrials.gov

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