ASIS for Botox in Cervical Dystonia

NCT02074293 | Unknown Phase 1 DMC

• 2 other identifiers: NCTNS089268R44NS089268
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.

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.

Keywords

Subdermal bloodless space; Subdermal injection; injectable EMG needle; electrical stimulation; MRI with Gadolinium; Cervical Dystonia; intramuscular injection; cervical dystonia,

Outcome Measures

Primary Outcomes (1)

• Relative Prolongation Ability Score for Gadolinium subdermally injected.

  Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) in Cervical Dystonia adult patients 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 %. This approximation can only work if the variables are minimized to the same population with Cervical Dystonia, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Cervical Dystonia patients will not be like those of normal patients, or even the same 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 Cervical Dystonia.

  12 months

Other Outcomes (1)

• Adverse Reactions of Botox intramuscularly vs. subdermally in Cervical Dystonia.

  12 months

Study Arms (22)

Splenius

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Scalene

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Sterno-cleido-mastoid

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Levator Scapulae

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Semispinalis

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Trapezius

EXPERIMENTAL

Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Drug: Gadolinium

Longissimus

EXPERIMENTAL

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 Pain Frequency

EXPERIMENTAL

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.

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 Pain Intensity

EXPERIMENTAL

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).

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 CDSS

EXPERIMENTAL

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).

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

Percent of Patients with Improved PGAS

EXPERIMENTAL

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.

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)

Levator Scapulae; Longissimus; Scalene; Semispinalis; Splenius; Sterno-cleido-mastoid; Trapezius

Efficacy of Botox intramuscularly at Week 6 DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox intramuscularly at Week 12 DRUG

Efficacy of Botox intramuscularly at Week 12, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox intramuscularly at Week 18 DRUG

Efficacy of Botox intramuscularly at Week 18, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox intramuscularly at Week 24 DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox intramuscularly at Week 30 DRUG

Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox subdermally at Week 6 DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox subdermally at Week 12 DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox subdermally at Week 18 DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox subdermally at Week 24 DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

Efficacy of Botox subdermally at Week 30 DRUG

Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Also known as: Botox (onabotulinumtoxinA)

Change from Baseline in CDSS; Change from Baseline in Pain Frequency; Change from Baseline in Pain Intensity; Percent of Patients with Improved PGAS

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• li nguyen: lead

Study Sites (1)

Automatic Subdermal Injector System, Inc

Westminster, California, 92683, United States

Location

Related Publications (9)

• 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

• Velickovic M, Benabou R, Brin MF. Cervical dystonia pathophysiology and treatment options. Drugs. 2001;61(13):1921-43. doi: 10.2165/00003495-200161130-00004.

  PMID: 11708764 BACKGROUND

• Claypool DW, Duane DD, Ilstrup DM, Melton LJ 3rd. Epidemiology and outcome of cervical dystonia (spasmodic torticollis) in Rochester, Minnesota. Mov Disord. 1995 Sep;10(5):608-14. doi: 10.1002/mds.870100513.

  PMID: 8552113 BACKGROUND

• Tiderington E, Goodman EM, Rosen AR, Hapner ER, Johns MM 3rd, Evatt ML, Freeman A, Factor S, Jinnah HA. How long does it take to diagnose cervical dystonia? J Neurol Sci. 2013 Dec 15;335(1-2):72-4. doi: 10.1016/j.jns.2013.08.028. Epub 2013 Aug 30.

  PMID: 24034410 BACKGROUND

• Albanese A, Sorbo FD, Comella C, Jinnah HA, Mink JW, Post B, Vidailhet M, Volkmann J, Warner TT, Leentjens AF, Martinez-Martin P, Stebbins GT, Goetz CG, Schrag A. Dystonia rating scales: critique and recommendations. Mov Disord. 2013 Jun 15;28(7):874-83. doi: 10.1002/mds.25579.

  PMID: 23893443 BACKGROUND

• Evidente VG, Fernandez HH, LeDoux MS, Brashear A, Grafe S, Hanschmann A, Comella CL. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin((R))) in cervical dystonia. J Neural Transm (Vienna). 2013 Dec;120(12):1699-707. doi: 10.1007/s00702-013-1048-3. Epub 2013 Jun 19.

  PMID: 23779062 BACKGROUND

• Leplow B, Bottcher M, Schonfeld R. [Botulinum toxin therapy for spasmodic torticollis: medical and non-medical adjunct treatment]. Nervenarzt. 2013 Apr;84(4):493-7. doi: 10.1007/s00115-012-3708-1. German.

  PMID: 23371379 BACKGROUND

• Vivancos-Matellano F, Ybot-Gorrin I, Diez-Tejedor E. A 17-year experience of abobotulinumtoxina in cervical dystonia. Int J Neurosci. 2012 Jul;122(7):354-7. doi: 10.3109/00207454.2012.665971. Epub 2012 Mar 20.

  PMID: 22329596 BACKGROUND

Related Links

• Click here for more information about this study ASIS for Botox in Cervical Dystonia

MeSH Terms

Conditions

Torticollis

Interventions

Gadolinium; Gadolinium DTPA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

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)