Trial record 2 of 4 for:    curemark

A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Curemark
Sponsor:
Information provided by (Responsible Party):
Curemark
ClinicalTrials.gov Identifier:
NCT02410902
First received: March 19, 2015
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to determine whether CM-AT is safe and effective in treating the core symptoms of autism in children with all levels of fecal chymotrypsin.

Condition Intervention Phase
Autism
Drug: CM-AT
Drug: PLACEBO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo-Controlled Study of CM-AT for the Treatment of Autism in Children With All Levels of Fecal Chymotrypsin (FCT)

Further study details as provided by Curemark:

Primary Outcome Measures:
  • Primary outcome measurements to determine efficacy of treatment with CM-AT versus placebo for changes in the Aberrant Behavior Checklist subscale for Irritability / Agitation (ABC-I) between baseline and Week 12/Termination visit [ Time Frame: Screening, baseline/14 days, 28 days, 42 days, 56 days, 70 days, 84 days, 98 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcome measurements of changes in the Aberrant Behavior Checklist Checklist subscale for Lethargy / Social Withdrawal (ABC-L) between baseline and Week 12/Termination visit [ Time Frame: Screening, baseline/14 days, 28 days, 42 days, 56 days, 70 days, 84 days, 98 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CM-AT
Active substance in single unit dose powder
Drug: CM-AT
Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
Placebo Comparator: Placebo
Placebo powder of inactive substance
Drug: PLACEBO
Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other Name: placebo powder

Detailed Description:
Autism is clearly a significant cause of disability in the pediatric population. Many children with Autism exhibit impaired protein digestion which may or may not manifest in self-restricted diets. The inability to digest protein affects the availability of essential amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is designed as a granulated powder taken three times daily.
  Eligibility

Ages Eligible for Study:   3 Years to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets the current Diagnostic and Statistical Manual with Mental Disorders (DSM-IV-TR) for Autism (Autistic Disorder), screened by SCQ and confirmed by ADI-R;

Exclusion Criteria:

  • Patient weighing < 13kg (28.6 lbs)
  • Previous allergy to porcine (pork) products
  • Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease
  • Diagnosis of: HIV, cerebral palsy, endocrine disorder, pancreatic disease, muscular dystrophy, known genetic disorder, blood dyscrasia, ongoing GI disease
  • Evidence of severe, moderate or uncontrolled systemic disease; and/or any co-morbid condition which in the Investigator's or Medical Director's opinion makes it undesirable for the subject to participate in the study or jeopardizes compliance with the protocol;
  • Within 30 days of starting the study, certain supplementation, chelation or dietary restriction (a 30 day washout period would be required for inclusion);
  • Ongoing dietary restriction for allergy or other reasons except nut allergies (lactose-free allowable);
  • Use of of any stimulant medication must be discontinued 5 days prior to entering the study.
  • Subject must have a stable dose of SSRI's for at least 30 days.
  • Inability to ingest study drug and/or follow prescribed dosing schedule
  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: NCT02410902

Contacts
Contact: Kristin Walsh, RN MSN 914-925-3697 clinical@curemark.com

  Show 30 Study Locations
Sponsors and Collaborators
Curemark
Investigators
Principal Investigator: Deborah Pearson, PhD The University of Texas Health Science Center, Houston
Principal Investigator: Robert Hendren, DO University of California, San Francisco
  More Information

Publications:
Baio, J. Prevalence of Autism Spectrum Disorders — Autism and Developmental Disabilities Monitoring Network, 14 Sites, United States. (2008), Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6103a1.htm?s_cid=ss6103a1_w.
Baio, J. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States. (2010). Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6302a1.htm?s_cid=ss6302a1_w.

Responsible Party: Curemark
ClinicalTrials.gov Identifier: NCT02410902     History of Changes
Other Study ID Numbers: 00103 
Study First Received: March 19, 2015
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Curemark:
Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2016