Development of Clinical Database of Individuals With Smit... | NCT03154697

Studies
Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances

NCT03154697

Sponsor

Vanda Pharmaceuticals

Status

Recruiting

Last Update Posted

Mar 20, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Sleep Disturbances in Smith-Magenis Syndrome

Interventions

Data collection of sleep disturbances in individuals with SMS

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Mar 16, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 16, 2017Actual

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

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection of sleep disturbances in individuals with SMS	Other	Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of individuals with Smith- Magenis syndrome		5 years

Secondary Outcomes

Measure	Description	Time Frame
Sleep Disturbances		Up to 100 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parent or legal guardian of individual with Smith-Magenis Syndrome

Exclusion Criteria:

Not legal guardian of individual with SMS

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

Individuals with SMS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanda Pharmaceuticals	Contact	202-734-3400		clinicaltrials@vandapharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Pharmaceuticals	Recruiting	Washington D.C.	District of Columbia	20037	United States

Intervention Browse Module

MeSH Terms

ID	Term
D013097	Spermine Synthase

Ancestor Terms

ID	Term
D019883	Alkyl and Aryl Transferases
D014166	Transferases
D004798	Enzymes
D045762	Enzymes and Coenzymes

Browse Leaves

Not provided

Browse Branches

Not provided