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Trial record 8 of 79 for:    PEELING SKIN SYNDROME

Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30

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ClinicalTrials.gov Identifier: NCT02431117
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Brief Summary:
To evaluate the suitability (i.e. number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values) of neurocognitive tests and functioning scales in view of their use in future multicenter, multinational clinical efficacy trials testing a putative cognitive enhancer for individuals with Down syndrome aged 6-30.

Condition or disease
Down Syndrome

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Longitudinal, Non-drug Study to Assess the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Japanese Individuals With Down Syndrome Aged 6-30
Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome




Primary Outcome Measures :
  1. Suitability for individuals with Down syndrome assessed by number of tests completed and number of participants completing the tests, variance estimate of baseline and of the change from baseline values. [ Time Frame: 26 weeks ]


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Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
People with Down syndrome
Criteria

Inclusion Criteria:

  • Subjects may have standard trisomy 21, Robertsonian translocation, isochromosome21,Down syndrome with reciprocal translocation or mosaicism.
  • Availability of parent or other reliable caregiver who agrees to accompany the subject to clinic visits, provide information about the subject's behavior and symptoms.
  • Down Syndrome subjects meeting clinical diagnostic criteria for generalized anxiety disorders, major depressive disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate to the study provided they are on stable medication for at least 8 weeks prior to screening.

Exclusion Criteria:

Individuals who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431117


Locations
Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Izumi, Osaka, Japan
Takatsuki, Osaka, Japan
Chiyoda-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Saitama, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Hideaki Takahashi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02431117     History of Changes
Other Study ID Numbers: JP29688
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn