A Study of RG1662 in Individuals With Down Syndrome

Down Syndrome Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Investigate Safety and Tolerability of RG1662 in Individuals With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436955
• Other study ID #: BP25543
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2011
• Last updated: March 2, 2015
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multi-center, randomized double-blind, placebo-controlled study will assess the safety and tolerability of RG1662 in individuals with Down Syndrome. Eligible subjects will be randomized in cohorts to receive either multiple oral doses of RG1662 or placebo. Anticipated time on study treatment is 38 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Adult individuals, 18 to 30 years of age, with diagnosis of Down Syndrome (confirmed by karyotype)

• Males and non-pregnant non-lactating females

• Parent or legal guardian/representative and caregiver willing to give written informed consent

• Subject willing and assenting or consenting to participate

Exclusion Criteria:

• Major depressive disorder not adequately controlled by a selective serotonin reuptake inhibitor or a serotonin norepinephrine reuptake inhibitor

• Subjects meeting clinical diagnostic criteria for autistic spectrum disorder, attention deficit or hyperactivity disorder unlikely to cooperate and take part successfully in the study assessments

• Subjects with other primary psychiatric diagnosis

• Subjects with evidence or meeting clinical diagnosis of dementia

• Subjects with personal history of cardiac abnormalities; patients that have previously undergone congenital heart surgery can be enrolled provided they have no residual complication requiring intervention (e.g. pace maker)

• Subjects with clinically significant obstructive pulmonary disease or asthma that is not adequately treated (oral steroids are not allowed)

• Subjects with thyroid dysfunction that is not adequately controlled and stabilized on treatment for at least 8 weeks

• Subjects with sustained elevated supine blood pressure (SBP/DBP) at rest exceeding 140/90 mmHg or notable resting tachycardia (mean HR > 60 bpm) or blood pressure below 90/40 mmHg

• Subjects who have taken any other investigational medications within 3 months

• Body mass index (BMI) > 40 kg/m2

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Intervention

Drug:
• Placebo
multiple oral doses
• RG1662
Cohorts receiving multiple oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		16 weeks	No
Secondary	Neurocognitive assessment: CANTAB (Computerized battery for assessing motor practice, reaction time and memory)/standard cognitive tests		5-6 weeks	No
Secondary	Pharmacokinetics: Serum concentration/area under the concentration-time curve (AUC)		5-6 weeks	No