A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

This study has been terminated.
(Due to potential competition with a post-marketing study requested by FDA)
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics
ClinicalTrials.gov Identifier:
NCT01927055
First received: August 16, 2013
Last updated: December 4, 2015
Last verified: December 2015
Results First Received: November 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Symptomatic Neurogenic Orthostatic Hypotension
Parkinson's Disease
Multiple Systems Atrophy
Pure Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
Interventions: Drug: Droxidopa
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
61 patients enrolled in the open-label dose titration, 16 patients discontinued in the open-label period and 45 patients continued on to the randomized double-blind treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open-label Titration

Droxidopa 100 mg, 200 mg

Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment

Droxidopa

Droxidopa 100 mg, 200 mg, 300 mg

Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment

Placebo

Placebo

Placebo: Placebo to match droxidopa capsules and strength designations


Participant Flow for 2 periods

Period 1:   Open-label
    Open-label Titration     Droxidopa     Placebo  
STARTED     61     0     0  
COMPLETED     45     0     0  
NOT COMPLETED     16     0     0  
Adverse Event                 6                 0                 0  
Withdrawal by Subject                 1                 0                 0  
Study Stopped                 4                 0                 0  
Supine Hypertension                 4                 0                 0  
Difficulty attending study visits                 1                 0                 0  

Period 2:   Double-Blind
    Open-label Titration     Droxidopa     Placebo  
STARTED     0     22     23  
COMPLETED     0     11     10  
NOT COMPLETED     0     11     13  
Adverse Event                 0                 1                 1  
Protocol Violation                 0                 0                 1  
Withdrawal by Subject                 0                 2                 3  
Study Stopped                 0                 7                 7  
Supine Hypertension                 0                 0                 1  
Extended Vacation                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open-Label Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
Droxidopa

Droxidopa 100 mg, 200 mg, 300 mg

Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment

Placebo

Placebo

Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment

Total Total of all reporting groups

Baseline Measures
    Open-Label     Droxidopa     Placebo     Total  
Number of Participants  
[units: participants]
  16     22     23     61  
Age  
[units: years]
Mean (Standard Deviation)
  74.3  (6.99)     70.2  (7.08)     70.8  (9.00)     70.5  (8.03)  
Gender  
[units: participants]
       
Female     2     9     7     18  
Male     14     13     16     43  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     0     1     0     1  
Not Hispanic or Latino     16     21     23     60  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     2     0     2     4  
White     13     22     21     56  
More than one race     0     0     0     0  
Unknown or Not Reported     1     0     0     1  
Region of Enrollment  
[units: participants]
       
United States     12     19     22     53  
Canada     4     3     1     8  
Primary Diagnosis  
[units: participants]
       
Parkinson's Disease     14     15     18     47  
Pure Autonomic Failure     1     3     3     7  
Multiple System Atrophy     1     4     2     7  
DBH Deficiency     0     0     0     0  



  Outcome Measures

1.  Primary:   Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)   [ Time Frame: Change from Randomization to Week 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was prematurely terminated; the limited sample size precludes meaningful conclusions on the efficacy or safety of droxidopa in this study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study director
Organization: H. Lundbeck A/S
e-mail: LundbeckClinicalTrials@Lundbeck.com



Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT01927055     History of Changes
Other Study ID Numbers: NOH401
Study First Received: August 16, 2013
Results First Received: November 2, 2015
Last Updated: December 4, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada