Long Term Treatment With L-DOPS | NCT00889135

Studies
Long Term Treatment With L-DOPS

NCT00889135

Sponsor

Vanderbilt University

Status

Approved for marketing

Last Update Posted

Oct 18, 2016Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Dopamine Beta Hydroxylase (DBH) Deficiency

Interventions

droxidopa

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 2016

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2004

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Apr 24, 2009

First Submission Date that Met QC Criteria

Apr 24, 2009

First Posted Date

Apr 28, 2009Estimated

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

Oct 14, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Description Module

Brief Summary

This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

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

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
droxidopa	Drug	Droxidopa (L-DOPS) comes in capsule form, 100 mg or 200 mg strength and is usually administered 2 - 3 times per day. It would be taken indefinitely to improve symptoms of orthostatic hypotension		L-DOPS DOPS

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old or older with orthostatic hypotension
established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies.

Exclusion Criteria:

subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Robertson, M.D.	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015103	Droxidopa

Ancestor Terms

ID	Term
D009638	Norepinephrine
D002395	Catecholamines
D000588	Amines
D009930	Organic Chemicals

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Browse Branches

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