ASIS for Botox in Upper Limb Spasticity

NCT02074150 | Unknown Phase 1 DMC

• 2 other identifiers: NCTHD081800R44HD081800
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Spasticity Unilaterally in Adults With History of Stroke; Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.

Keywords

Subdermal bloodless space; Subdermal injection; injectable EMG needle; electrical stimulation; MRI with Gadolinium; Upper Limb Spasticity; intramuscular injection

Outcome Measures

Primary Outcomes (1)

• Relative Prolongation Ability Score for Gadolinium subdermally injected.

  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.

  6 months

Secondary Outcomes (1)

• Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity.

  12 months

Other Outcomes (1)

• Adverse Reactions of Botox intramuscularly vs. subdermally in Upper Limb Spasticity

  12 months

Study Arms (23)

Biceps Brachii

EXPERIMENTAL

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

Flexor Carpi Radialis

EXPERIMENTAL

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

Flexor carpi ulnaris

EXPERIMENTAL

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

Flexor digitorum profundus

EXPERIMENTAL

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

Flexor digitorum sublimis

EXPERIMENTAL

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

Adductor pollicis

EXPERIMENTAL

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

Flexor pollicis longus

EXPERIMENTAL

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

Change from Baseline in Elbow Ashworth

EXPERIMENTAL

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; 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

Change from Baseline in Wrist Ashworth

EXPERIMENTAL

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; 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

Change from Baseline in Finger Ashworth

EXPERIMENTAL

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; 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

Change from Baseline in Thumb Ashworth

EXPERIMENTAL

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; 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

Change from Baseline in PGAS

EXPERIMENTAL

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; 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

Adverse Reactions with Facial paresis

EXPERIMENTAL

Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Eyelid ptosis

EXPERIMENTAL

Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Bronchitis

EXPERIMENTAL

Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Neck pain

EXPERIMENTAL

Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle stiffness

EXPERIMENTAL

Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscular weakness

EXPERIMENTAL

Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Myalgia

EXPERIMENTAL

Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle pain

EXPERIMENTAL

Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Muscle spasms

EXPERIMENTAL

Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions Injection site pain

EXPERIMENTAL

Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Adverse Reactions with Hypertension

EXPERIMENTAL

Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally

Interventions

Gadolinium DRUG

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.

Also known as: Gadolinium Magnevist® (gadopentetate dimeglumine)

Adductor pollicis; Biceps Brachii; Flexor Carpi Radialis; Flexor carpi ulnaris; Flexor digitorum profundus; Flexor digitorum sublimis; Flexor pollicis longus

Efficacy of Botox intramuscularly at Week 6 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox intramuscularly at Week 12, DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox intramuscularly at Week 18 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox intramuscularly at Week 24 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox intramuscularly at Week 30 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox subdermally at Week 6 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox subdermally at Week 12 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox subdermally at Week 18 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox subdermally at Week 24 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Efficacy of Botox subdermally at Week 30 DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in Elbow Ashworth; Change from Baseline in Finger Ashworth; Change from Baseline in PGAS; Change from Baseline in Thumb Ashworth; Change from Baseline in Wrist Ashworth

Adverse Reactions of Botox intramuscularly DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Adverse Reactions Injection site pain; Adverse Reactions with Bronchitis; Adverse Reactions with Eyelid ptosis; Adverse Reactions with Facial paresis; Adverse Reactions with Hypertension; Adverse Reactions with Muscle pain; Adverse Reactions with Muscle spasms; Adverse Reactions with Muscle stiffness; Adverse Reactions with Muscular weakness; Adverse Reactions with Myalgia; Adverse Reactions with Neck pain

Adverse Reactions of Botox subdermally DRUG

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.

Also known as: Botox (onabotulinumtoxinA)

Adverse Reactions Injection site pain; Adverse Reactions with Bronchitis; Adverse Reactions with Eyelid ptosis; Adverse Reactions with Facial paresis; Adverse Reactions with Hypertension; Adverse Reactions with Muscle pain; Adverse Reactions with Muscle spasms; Adverse Reactions with Muscle stiffness; Adverse Reactions with Muscular weakness; Adverse Reactions with Myalgia; Adverse Reactions with Neck pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• li nguyen: lead

Study Sites (1)

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Related Publications (7)

• Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.

  PMID: 23515199 BACKGROUND

• Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42.

  PMID: 16763467 BACKGROUND

• Turner-Stokes L, Ward A. Botulinum toxin in the management of spasticity in adults. Clin Med (Lond). 2002 Mar-Apr;2(2):128-30. doi: 10.7861/clinmedicine.2-2-128.

  PMID: 11991094 BACKGROUND

• Patrick E, Ada L. The Tardieu Scale differentiates contracture from spasticity whereas the Ashworth Scale is confounded by it. Clin Rehabil. 2006 Feb;20(2):173-82. doi: 10.1191/0269215506cr922oa.

  PMID: 16541938 BACKGROUND

• Jost WH, Hefter H, Reissig A, Kollewe K, Wissel J. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci. 2014 Feb 15;337(1-2):86-90. doi: 10.1016/j.jns.2013.11.022. Epub 2013 Nov 22.

  PMID: 24361062 BACKGROUND

• Baker JA, Pereira G. The efficacy of Botulinum Toxin A for spasticity and pain in adults: a systematic review and meta-analysis using the Grades of Recommendation, Assessment, Development and Evaluation approach. Clin Rehabil. 2013 Dec;27(12):1084-96. doi: 10.1177/0269215513491274. Epub 2013 Jul 17.

  PMID: 23864518 BACKGROUND

• Ghasemi M, Salari M, Khorvash F, Shaygannejad V. A literature review on the efficacy and safety of botulinum toxin: an injection in post-stroke spasticity. Int J Prev Med. 2013 May;4(Suppl 2):S147-58.

  PMID: 23776717 BACKGROUND

Related Links

• Click here for more information about this study ASIS for Botox in Upper Limb Spasticity

MeSH Terms

Interventions

Gadolinium; Gadolinium DTPA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Li Nguyen, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC

  PRINCIPAL INVESTIGATOR

• Thanh Phung,, MD

  AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Nguyen, MD

CONTACT

(714)-453-7857; dr.li.nguyen@asis-inc.com

Thanh Phung, MD

CONTACT

714-893-1915; thanhphung@idit-inc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD/CEO/PI

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

US (1)