A Phase 2 interventional study of Placebo and RO5186582 in Down Syndrome, sponsored by Hoffmann-La Roche. Terminated at 9 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2017-07-06.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This study will evaluate the safety, tolerability, efficacy, and pharmacokinetic and pharmacodynamic activity of 3 different dosages of RO5186582 compared with placebo. A total of approximately 46 participants will be enrolled, in order to have at least 32 evaluable, and will be randomly assigned to 1 of 4 treatments in a 1:1:1:1 ratio, with 9 children per treatment arm. The target ratio between 6-8 years and 9-11 years age groups is approximately 1:1 in each treatment arm, with a minimum of 3 children per age group in each treatment arm.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 45 is above the median of 36 across 283 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive matching placebo by mouth (PO) twice daily (BID) for up to 26 weeks.
Drug: Placebo
Participants will receive RO5186582 at a dosage of 120 milligrams (mg) PO BID for up to 26 weeks.
Drug: RO5186582
Participants will receive RO5186582 at a dosage of 40 mg PO BID for up to 26 weeks.
Drug: RO5186582
Participants will receive RO5186582 at a dosage of 60 mg PO BID for up to 26 weeks.
Drug: RO5186582
Participants will receive matching placebo PO BID. Study medication will first be administered on Day 1, and only the morning dose will be given on the last day of treatment (Week 26).
Participants will receive 1 of 3 dosages of RO5186582 PO BID, including 40 mg, 60 mg, or 120 mg. Study medication will first be administered on Day 1, and only the morning dose will be given on the last day of treatment (Week 26).
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 6
Percentage of Participants With Epileptiform Abnormalities as Assessed Using Electroencephalogram (EEG) Analysis
Time frame: Baseline up to Week 6
Percentage of Participants by Suicidality Classification as Assessed Using an Adapted Form of the Columbia Classification Algorithm for Suicide Assessment (C-CASA)
Time frame: Baseline up to Week 6
Anxiety, Depression, and Mood Scale (ADAMS) Score
Time frame: Baseline up to Week 6
Hyperactivity and Impulsivity as Assessed by the Short Version of Conners Third Edition Parent Short-Form (Conners-3) Score
Time frame: Baseline up to Week 6
Sleep Disturbances as Assessed by the Children's Sleep Habits Questionnaire (CSHQ) Score
Time frame: Baseline up to Week 6
Gamma Power at Posterior Electrodes as Assessed Using EEG Analysis
Time frame: Baseline up to Week 6
Theta Power at Posterior Electrodes as Assessed Using EEG Analysis
Time frame: Baseline up to Week 6
Cognition as Assessed by the Children's Memory Scale (CMS) Subtests Score
Time frame: Baseline up to Week 6
Percentage of Participants With AEs
Time frame: Baseline up to Week 26
Percentage of Participants With Epileptiform Abnormalities as Assessed Using EEG Analysis
Time frame: Baseline up to Week 26
Percentage of Participants by Suicidality Classification as Assessed Using an Adapted Form of the C-CASA
Time frame: Baseline up to Week 26
ADAMS Score
Time frame: Baseline up to Week 26
Hyperactivity and Impulsivity as Assessed by the Short Version of Conners-3 Score
Time frame: Baseline up to Week 26
Sleep Disturbances as Assessed by the CSHQ Score
Time frame: Baseline up to Week 26
Gamma Power at Posterior Electrodes as Assessed Using EEG Analysis
Time frame: Baseline up to Week 26
Theta Power at Posterior Electrodes as Assessed Using EEG Analysis
Time frame: Baseline up to Week 26
Cognition as Assessed by the CMS Subtests Score
Time frame: Baseline up to Week 26
Adaptive Behavior as Assessed by the Vineland Adaptive Behavior Scales-II (VABS-II) Score
Time frame: Baseline up to Week 26
Clinical Global Impression-Improvement (CGI-I) Scale Score
Time frame: Baseline up to Week 26
Daily Functional Memory as Assessed by the Observer Memory Questionnaire-Parent Form (OMQ-PF) Score
Time frame: Baseline up to Week 26
Intellectual Quotient (IQ) as Assessed by the Leiter 3
Time frame: Baseline up to Week 26
Plasma Concentration of RO5186582
Time frame: Predose (2 predose samples separated by at least 1 hour) at Weeks 2 and 6; and predose or postdose (as convenient) during Weeks 10, 17, and 26
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche