Dopamine Beta Hydroxylase (DBH) DeficiencyNCT00889135
Long Term Treatment With L-DOPS
A study testing droxidopa in people with Dopamine Beta Hydroxylase (DBH) Deficiency, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dopamine Beta Hydroxylase (DBH) Deficiency
- What is being tested?
- droxidopa
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2015
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
- Being tested
- droxidopa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
droxidopaDrug
Also called L-DOPS, DOPS
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startSep 2004
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dopamine Beta Hydroxylase (DBH) DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Robertson, Vanderbilt University
- Investigators
- David Robertson, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889135
- Sponsor's protocol ID
- 041037
- Status last verified
- Oct 2016
- First submitted
- 24 Apr 2009
- Last updated
- 18 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Treatment With L-DOPS
- ClinicalTrials.gov ID
- NCT00889135
- Acronym / sponsor ID
- 041037
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| droxidopaAlso: L-DOPS, DOPSDroxidopa (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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Robertson, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing droxidopa in people with Dopamine Beta Hydroxylase (DBH) Deficiency, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.