Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liq-NOL Efficacy in Pediatric Patients With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891917
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Michael V. Miles, Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE April 29, 2009
First Posted Date  ICMJE May 1, 2009
Last Update Posted Date January 29, 2014
Study Start Date  ICMJE January 2005
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
To measure the effects of LiQ-NOL on language skills, expressive language ability, and speech articulation. [ Time Frame: beginning and end of 3 month treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00891917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
To evaluate the effects of LiQ-NOL on child behavior. [ Time Frame: beginning and end of 3 month treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liq-NOL Efficacy in Pediatric Patients With Down Syndrome
Official Title  ICMJE Evaluation of Coenzyme q10 (Liq-nol®) Efficacy in Pediatric Patients With Down Syndrome
Brief Summary The purpose of this study is to measure the effects of LiQ-NOL supplementation on language production using the Clinical Evaluation of Language Fundamentals test, language sampling using the mean length of utterance test, and speech articulation using the Goldman-Fristoe Test of Articulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Down Syndrome
Intervention  ICMJE Drug: Ubiquinol-10 Syrup
10 mg/kg/day in 2 divided doses for 3 months or Placebo Syrup for 3 months
Other Name: LiQ-NOL
Study Arms  ICMJE
  • Placebo Comparator: Syrup
    Intervention: Drug: Ubiquinol-10 Syrup
  • Active Comparator: Ubiquinol-10 Syrup
    Intervention: Drug: Ubiquinol-10 Syrup
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
36
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ranging from 6.0 years to 16 years of age.
  • Patients will have proven Trisomy 21.
  • Females, incapable of bearing children or capable of practicing adequate birth control methods. Abstinence will be acceptable.
  • Written informed consent will be obtained from parents of all subjects prior to enrollment. Verbal assent will be obtained from all patients with DS who have sufficient decision making ability and are at least 11 years old.

Exclusion Criteria:

  • Patients who have insufficient mental and/or motor capacity to complete testing measures.
  • Patients less than 6 years or older than 16 years of age.
  • Patients receiving CoQ supplementation within one month prior to the study.
  • Patients with evidence of disease which may adversely affect CoQ absorption, e.g. chronic diarrhea or inflammatory bowel disease.
  • Patients participating in other research studies or having exposure to investigational drugs within one month prior to this study.
  • Females, capable of bearing children, who are unsure of their pregnancy status or not practicing adequate birth control methods.
  • Females who are pregnant.
  • Patients with a known allergy to CoQ.
  • Patients receiving drug treatment which is know to affect CoQ, e.g. cholesterol-lowering drugs such as "statins".
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891917
Other Study ID Numbers  ICMJE 04-12-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Michael V. Miles, Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael V Miles, Pharm.D. Childrens Hospital Medical Center, Cincinnati
Principal Investigator: Francis Hickey, M.D. Childrens Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP