Augmenting Effects of L-DOPS With Carbidopa and Entacapone

This study has been terminated.
(Study terminated due to contamination droxidopa)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT00547911
First received: October 19, 2007
Last updated: June 17, 2014
Last verified: June 2014
Results First Received: June 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Parkinson Disease
Multiple System Atrophy
Autonomic Nervous System Diseases
Interventions: Drug: Droxidopa
Drug: Carbidopa
Drug: Entacapone

  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
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.

Participant Flow:   Overall Study
    LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT     LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR     LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT     LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo     LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR     LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo  
STARTED     2     2     2     2     3     3  
COMPLETED     2     2     2     1     3     3  
NOT COMPLETED     0     0     0     1     0     0  
Adverse Event                 0                 0                 0                 1                 0                 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
Healthy Volunteer Subjects in good general health
Pure Autonomic Failure Subjects with Pure Autonomic Failure
Multiple System Atrophy Subjects with autonomic failure and a history of Multiple System Atrophy
Parkinson's Disease Subjects with autonomic failure and a history of Parkinson's Disease
Total Total of all reporting groups

Baseline Measures
    Healthy Volunteer     Pure Autonomic Failure     Multiple System Atrophy     Parkinson's Disease     Total  
Number of Participants  
[units: participants]
  2     7     2     3     14  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 1.5     68.6  ± 8.1     57.0  ± 0     65.0  ± 7.1     64.0  ± 8.8  
Gender  
[units: participants]
         
Female     0     2     1     1     4  
Male     2     5     1     2     10  



  Outcome Measures
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1.  Primary:   Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 48 hours after receiving drug(s) ]

2.  Primary:   Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 48 hours after receiving drug(s) ]

3.  Primary:   Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 48 hours after receiving drug(s) ]

4.  Primary:   Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 48 hours after receiving drug(s) ]

5.  Secondary:   Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 24 hours after receiving drug(s) ]

6.  Secondary:   Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 24 hours after receiving drug(s) ]

7.  Secondary:   Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone   [ Time Frame: Up to 24 hours after receiving drug(s) ]


  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
Study was prematurely terminated due to a small amount of DOPAL contamination in the droxidopa. Because of the early termination only a small number of subjects were enrolled in each condition. Recently, the FDA has approved droxidopa.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Goldstein
Organization: National Institutes of Health
phone: 301-496-1115
e-mail: goldsteind@ninds.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00547911     History of Changes
Other Study ID Numbers: 080012, 08-N-0012
Study First Received: October 19, 2007
Results First Received: June 17, 2014
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration