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Trial · NCT00858689

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline of ABC Irritability Subtest Score at 8 WeeksBaseline and 8 weeks
The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9.
PrimaryABC Irritability Subtest Score8 weeksABC Irritability subtest score was used
PrimaryABC Irritability Subtest Score1 yearABC (Aberrant behavior checklist) Irritability subtest score was used
SecondaryParent Defined Target Symptoms Scale-VisualBaseline
SecondaryClinical Global Impression ScaleBaseline
SecondaryStanford Binet 5 (SB5)Baseline
SecondaryThe Peabody Picture Vocabulary Test Third Edition (PPVT-III)Baseline
SecondaryThe Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)Baseline
SecondaryNon-Verbal Associative Learning Task (NVALT)Baseline
SecondaryVineland Adaptive Behaviour Scales (VABS)Baseline
SecondaryParent Defined Target Symptoms Scale-Visual8 weeks
SecondaryParent Defined Target Symptoms Scale-Visual1 year
SecondaryClinical Global Impression Scale8 weeks
SecondaryClinical Global Impression Scale1 year
SecondaryStanford Binet 5 (SB5)1 year
SecondaryThe Peabody Picture Vocabulary Test Third Edition (PPVT-III)8 weeks
SecondaryThe Peabody Picture Vocabulary Test Third Edition (PPVT-III)1 year
SecondaryThe Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)8 weeks
SecondaryThe Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)1 year
SecondaryNon-Verbal Associative Learning Task (NVALT)8 weeks

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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