Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (NOH303)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics
ClinicalTrials.gov Identifier:
NCT00738062
First received: August 19, 2008
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: March 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Neurogenic Orthostatic Hypotension
Non-Diabetic Autonomic Neuropathy
Multiple System Atrophy
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
No text entered.

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 Droxidopa 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
Double-blind Droxidopa

Double-blind

Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

Double-blind Placebo

Double-blind

Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day


Participant Flow for 3 periods

Period 1:   Open Label Treatment
    Open-Label Droxidopa     Double-blind Droxidopa     Double-blind Placebo  
STARTED     103     0     0  
COMPLETED     75     0     0  
NOT COMPLETED     28     0     0  
Lack of Efficacy                 5                 0                 0  
Adverse Event                 11                 0                 0  
Protocol Violation                 2                 0                 0  
Withdrawal by Subject                 9                 0                 0  
Investigator Decision                 1                 0                 0  

Period 2:   2 Week Randomized Withdrawal
    Open-Label Droxidopa     Double-blind Droxidopa     Double-blind Placebo  
STARTED     0 [1]   38     37  
COMPLETED     0     38     37  
NOT COMPLETED     0     0     0  
[1] Patients completing the open label titration phase were randomized to either Droxidopa or Placebo

Period 3:   Open-Label Extension
    Open-Label Droxidopa     Double-blind Droxidopa     Double-blind Placebo  
STARTED     74 [1]   0     0  
COMPLETED     57     0     0  
NOT COMPLETED     17     0     0  
Adverse Event                 5                 0                 0  
Physician Decision                 1                 0                 0  
Lack of Efficacy                 2                 0                 0  
Withdrawal by Subject                 6                 0                 0  
Protocol Violation                 1                 0                 0  
Study Terminated                 2                 0                 0  
[1] One patient completed double blind randomization but did not enter the open label extension



  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.
Omits 1 patient who randomized into the study in error and did not receive study drug.

Reporting Groups
  Description
Open-Label Droxidopa Only participated in 3 months of open-label treatment with droxidopa (t.i.d., at optimal dose)
Double-blind Droxidopa

Double-blind

Droxidopa: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

Double-blind Placebo

Double-blind

Placebo: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

Total Total of all reporting groups

Baseline Measures
    Open-Label Droxidopa     Double-blind Droxidopa     Double-blind Placebo     Total  
Number of Participants  
[units: participants]
  27     38     37     102  
Age  
[units: years]
Mean ± Standard Deviation
  61.9  ± 10.95     68.2  ± 13.03     66.2  ± 12.09     65.8  ± 12.31  
Gender  
[units: participants]
       
Female     13     15     13     41  
Male     14     23     24     61  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     1     1  
Asian     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     27     37     36     100  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     16     25     22     63  
Canada     2     6     3     11  
Australia     2     2     2     6  
New Zealand     0     1     1     2  
United Kingdom     0     1     3     4  
Poland     7     3     6     16  
Primary Clinical Diagnosis  
[units: participants]
       
Parkinson's Disease     10     20     18     48  
Multiple System Atrophy     10     8     9     27  
Pure Autonomic Failure     3     8     7     18  
Dopamine Beta-Hydroxylase Deficiency     0     1     0     1  
Non-Diabetic Autonomic Neuropathy     3     0     2     5  
Other     1     1     1     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)   [ Time Frame: 14 days ]

2.  Secondary:   Change in Orthostatic Hypotension Daily Activities (OHDAS) Score   [ Time Frame: 14 days ]

3.  Secondary:   Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score   [ Time Frame: 14 days ]

4.  Secondary:   Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing   [ Time Frame: 14 days ]

5.  Secondary:   Patient Reported Clinical Global Impression - Severity   [ Time Frame: 14 days ]

6.  Secondary:   Clinician Recorded Clinical Global Impression - Severity   [ Time Frame: 14 days ]

7.  Secondary:   Patient Reported Clinical Global Impression - Improvement   [ Time Frame: 14 days ]

8.  Secondary:   Clinician Rated Clinical Global Impressions - Improvement   [ Time Frame: 14 days ]

9.  Post-Hoc:   Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)   [ Time Frame: 14 days ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
phone: 704-973-4202
e-mail: hewitt@chelsearx.com


No publications provided


Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT00738062     History of Changes
Other Study ID Numbers: Droxidopa NOH303
Study First Received: August 19, 2008
Results First Received: March 18, 2014
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration