Evaluating the Effects of Tasimelteon vs Placebo on Sleep... | NCT02231008

Studies
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

NCT02231008

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Nov 18, 2022Actual

Enrollment

49Actual

Phase

Phase 2Phase 3

Conditions

Smith-Magenis Syndrome
Circadian

Interventions

tasimelteon
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Nov 19, 2018Actual

Completion Date

Jan 2022Actual

First Submitted Date

Aug 29, 2014

First Submission Date that Met QC Criteria

Sep 2, 2014

First Posted Date

Sep 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2022

Last Update Posted Date

Nov 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tasimelteon	Experimental	Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage	Drug: tasimelteon
Placebo	Placebo Comparator	Placebo comparator	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tasimelteon	Drug		Tasimelteon
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters		9 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).		up to 137 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A confirmed clinical diagnosis of SMS
Informed consent from the patient or the legal guardian
Male or female between the ages of 3- 65 years of age
Recent history of sleep disturbances
Have an appointed care-giver complete the required outpatient assessments
Willing and able to comply with study requirements and restrictions

Exclusion Criteria:

Unable to dose daily with medication
Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
Any other sound medical reason as determined by the clinical investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Santa Monica	California		United States

Type	Date	Date Unknown
Release	Feb 26, 2025
Reset	Mar 17, 2025
Release	Apr 1, 2025
Reset	Apr 14, 2025
Release	Apr 29, 2025
Reset	May 14, 2025

Submission Tracking

Estimated Results First Submitted Date

Feb 26, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 26, 2025			Mar 17, 2025
Apr 1, 2025

Condition Browse Module

MeSH Terms

ID	Term
D058496	Smith-Magenis Syndrome

Ancestor Terms

ID	Term
D021081	Chronobiology Disorders
D009422	Nervous System Diseases
D000015	Abnormalities, Multiple
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C478745	tasimelteon

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided