Long Term Treatment With L-DOPS

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Robertson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00889135
First received: April 24, 2009
Last updated: January 3, 2013
Last verified: September 2011
  Purpose

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.


Condition Intervention
Dopamine Beta Hydroxylase (DBH) Deficiency
Drug: droxidopa

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Treatment With L-DOPS

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Less dizziness while in standing posture. [ Time Frame: 3 month intervals ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2004
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
L-DOPS (droxidopa)
Supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency.
Drug: droxidopa
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
Other Names:
  • L-DOPS
  • DOPS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889135

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David Robertson, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: David Robertson, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00889135     History of Changes
Other Study ID Numbers: 041037
Study First Received: April 24, 2009
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Droxidopa
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014