ASIS for Botox in Upper Limb Spasticity (ASISinULS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by ASIS Corporation
Sponsor:
Information provided by (Responsible Party):
li nguyen, ASIS Corporation
ClinicalTrials.gov Identifier:
NCT02074150
First received: February 26, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

Botox act 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.


Condition Intervention Phase
Upper Limb Spasticity Unilaterally in Adults With History of Stroke
Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
Drug: Gadolinium
Drug: Efficacy of Botox intramuscularly at Week 6
Drug: Efficacy of Botox intramuscularly at Week 12,
Drug: Efficacy of Botox intramuscularly at Week 18
Drug: Efficacy of Botox intramuscularly at Week 24
Drug: Efficacy of Botox intramuscularly at Week 30
Drug: Efficacy of Botox subdermally at Week 6
Drug: Efficacy of Botox subdermally at Week 12
Drug: Efficacy of Botox subdermally at Week 18
Drug: Efficacy of Botox subdermally at Week 24
Drug: Efficacy of Botox subdermally at Week 30
Drug: Adverse Reactions of Botox intramuscularly
Drug: Adverse Reactions of Botox subdermally
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ASIS for Botox in Upper Limb Spasticity

Resource links provided by NLM:


Further study details as provided by ASIS Corporation:

Primary Outcome Measures:
  • Relative Prolongation Ability Score for Gadolinium subdermally injected. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Gadolinium will be injected with ASIS subdermally (30) or intramuscularly (30) in Upper Limb Spasticity adult patients for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. MRI will be taken promptly after, as starting reference, to which subsequent MRI at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Upper Limb Spasticity, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Upper Limb Spasticity patients will not be same as normal patients, or even between these 7 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.


Secondary Outcome Measures:
  • Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of improvement on the Physician Global Assessment Scale (-4=very marked worsening to +4=very marked improvement). Also in terms of improvement, or Median Change from Baseline in Flexor Tone on Ashworth Scale, for Elbow, Wrist, Finger, and Thumb. Ashworth score (the force required to move an extremity around a joint):

    0 = No increase in muscle tone (none)

    1. = Slight increase in muscle tone, giving a 'catch' when the limb was flexed or extended (mild)
    2. = More marked increase in muscle tone but affected limb is easily flexed (moderate)
    3. = Considerable increase in muscle tone - passive movement difficult (severe)
    4. = Limb rigid in flexion or extension (very severe).


Other Outcome Measures:
  • Adverse Reactions of Botox intramuscularly vs. subdermally in Upper Limb Spasticity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Adverse Reactions of Botox intramuscularly vs. subdermally:

    Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.



Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biceps Brachii

Biceps Brachii (elbow flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Flexor Carpi Radialis

Flexor Carpi Radialis (wrist flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Flexor carpi ulnaris

Flexor carpi ulnaris (wrist flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Flexor digitorum profundus

Flexor digitorum profundus (finger flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Flexor digitorum sublimis

Flexor digitorum sublimis (finger flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Adductor pollicis

Adductor pollicis (thumb flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Flexor pollicis longus

Flexor pollicis longus (thumb flexors)

Gadolinium Magnevist® (gadopentetate dimeglumine)

.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium

Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.

Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.

Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Drug: Gadolinium
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Other Name: Gadolinium Magnevist® (gadopentetate dimeglumine)
Experimental: Change from Baseline in Elbow Ashworth

Change from Baseline in Elbow Ashworth Scale 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. Ashworth score (the force required to move an extremity around a joint):

0 = No increase in muscle tone (none)

  1. = Slight increase
  2. = Moderate increase
  3. = Considerable increase
  4. = Limb rigid (very severe).
Drug: Efficacy of Botox intramuscularly at Week 6
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12,
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Change from Baseline in Wrist Ashworth

Change from Baseline in Wrist Ashworth Scale 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.Ashworth score (the force required to move an extremity around a joint):

0 = No increase in muscle tone (none)

  1. = Slight increase
  2. = Moderate increase
  3. = Considerable increase
  4. = Limb rigid (very severe).
Drug: Efficacy of Botox intramuscularly at Week 6
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12,
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Change from Baseline in Finger Ashworth

Change from Baseline in Finger Ashworth Scale 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. Ashworth score (the force required to move an extremity around a joint):

0 = No increase in muscle tone (none)

  1. = Slight increase
  2. = Moderate increase
  3. = Considerable increase
  4. = Limb rigid (very severe).
Drug: Efficacy of Botox intramuscularly at Week 6
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12,
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Change from Baseline in Thumb Ashworth

Change from Baseline in Thumb Ashworth Scale 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. Ashworth score (the force required to move an extremity around a joint):

0 = No increase in muscle tone (none)

  1. = Slight increase
  2. = Moderate increase
  3. = Considerable increase
  4. = Limb rigid (very severe).
Drug: Efficacy of Botox intramuscularly at Week 6
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12,
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Change from Baseline in PGAS
Change from Baseline in 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.
Drug: Efficacy of Botox intramuscularly at Week 6
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 12,
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 18
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 24
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox intramuscularly at Week 30
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 6
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 12
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 18
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 24
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Drug: Efficacy of Botox subdermally at Week 30
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Facial paresis
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Eyelid ptosis
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Bronchitis
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Neck pain
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle stiffness
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscular weakness
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Myalgia
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle pain
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Muscle spasms
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions Injection site pain
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Experimental: Adverse Reactions with Hypertension
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Drug: Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)
Drug: Adverse Reactions of Botox subdermally
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Other Name: Botox (onabotulinumtoxinA)

Detailed Description:

Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Upper limb Spasticity. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. 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 Upper limb Spasticity, and these particular 7 muscle groups. Case in point, patients with Upper limb Spasticity presumably have hyperactivity in these 7 muscle groups, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Upper limb Spasticity 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 the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.

Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Upper limb Spasticity, on these particular 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Upper limb Spasticity 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 and Ashworth score (force required to move an extremity around a joint), at 6,12,18,24, and 30 weeks, and reduction in adverse reactions.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity
  • Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale
  • Ability to understand and follow verbal directions
  • At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS)
  • At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no.

Exclusion Criteria:

  • Stroke within 6 months of the study enrollment visit
  • Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception
  • Previous or current Botox therapy of any type in the study limb
  • Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function
  • Presence of fixed contracture of the study limb
  • Limited use of the wrist and fingers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074150

Contacts
Contact: Li Nguyen, MD (714)-453-7857 dr.li.nguyen@asis-inc.com
Contact: Thanh Phung, MD 714-893-1915 thanhphung@idit-inc.com

Locations
United States, California
Automatic Subdermal Injector System, Inc Not yet recruiting
Westminster, California, United States, 92683
Contact: Li Nguyen, MD    714-453-7857    dr.li.nguyen@asis-inc.com   
Contact: Thanh Phung ,, MD    7148931915    thanhphung@idit-inc.com   
Principal Investigator: Li Nguyen, MD         
Sponsors and Collaborators
li nguyen
Investigators
Principal Investigator: Li Nguyen, MD AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Principal Investigator: Thanh Phung ,, MD AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
  More Information

Additional Information:
Publications:

Responsible Party: li nguyen, MD/CEO/PI, ASIS Corporation
ClinicalTrials.gov Identifier: NCT02074150     History of Changes
Other Study ID Numbers: NCTHD081800, R44HD081800
Study First Received: February 26, 2014
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ASIS Corporation:
Subdermal bloodless space
Subdermal injection
injectable EMG needle
electrical stimulation
MRI with Gadolinium
Upper Limb Spasticity
intramuscular injection

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Gadolinium DTPA
Gadobenic acid
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 18, 2014