A Study With RO4917523 in Patients With Fragile X Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01015430

First received: November 17, 2009

Last updated: November 1, 2016

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2009

Last Updated Date

November 1, 2016

Start Date ^ICMJE

November 2009

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety, Tolerability and Pharmacokinetics: AEs, laboratory parameters [ Time Frame: AEs throughout study; laboratory assessments: days 1, 8, 15, 29, 43 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015430 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy: Behavior and cognition assessments [ Time Frame: Every 2 weeks throughout study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study With RO4917523 in Patients With Fragile X Syndrome

Official Title ^ICMJE

A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.

Brief Summary

This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is <100 patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Fragile X Syndrome

Intervention ^ICMJE

Drug: Placebo (for RO4917523 ascending doses)
Placebo daily po
Drug: Placebo (for RO4917523 fixed dose)
Placebo daily po
Drug: RO4917523
RO4917523 ascending doses daily po
Drug: RO4917523
RO4917523 fixed dose daily po

Study Arms

Placebo Comparator: Placebo (for RO4917523 ascending doses)
Interventions:
- Drug: Placebo (for RO4917523 ascending doses)
- Drug: Placebo (for RO4917523 fixed dose)
Placebo Comparator: Placebo (for RO4917523 fixed dose)
Interventions:
- Drug: Placebo (for RO4917523 ascending doses)
- Drug: Placebo (for RO4917523 fixed dose)
Experimental: RO4917523 ascending doses
Intervention: Drug: RO4917523
Experimental: RO4917523 fixed dose
Intervention: Drug: RO4917523

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, 18 to 50 years of age
Fragile X Syndrome
IQ less than 75
Reliable caregiver

Exclusion Criteria:

Current psychosis or presumption of psychosis
History of suicidal behavior or considered a high suicidal risk
Severe self-injurious behavior
Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
Current seizure disorder

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

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

NCT01015430

Other Study ID Numbers ^ICMJE

NP22578

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

PRS Account

Hoffmann-La Roche

Verification Date

November 2016

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

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