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

Primary Purpose

Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Droxidopa
Placebo
Sponsored by
Chelsea Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Neurogenic Orthostatic Hypotension focused on measuring NOH, OH, PD, MSA, PAF, DBH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. 18 years and older and ambulatory (defined as able to walk at least 10 meters);

    2. Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency;

    3. At the Baseline visit (Visit 2), patients must demonstrate:

    1. a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1;
    2. a fall of at least 20 mmHg in their systolic blood pressure, within 3 minutes of standing;

      4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care;

      Exclusion Criteria:

  • 1. Score of 23 or lower on the mini-mental state examination (MMSE);

    2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;

    1. Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study;

      3. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse);

      4. Women who are pregnant or breastfeeding;

      5. Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner;

      6. Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception;

      7. Untreated closed angle glaucoma;

      8. Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine HTN are allowed in this study) Any significant uncontrolled cardiac arrhythmia;

      9. History of myocardial infarction, within the past 2 years;

      10. Current unstable angina;

      11. Congestive heart failure (NYHA Class 3 or 4);

      12. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ;

      13. Gastrointestinal condition that may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass);

      14. Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2);

      15. Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2);

      16. Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2);

      17. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study;

      18. The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.

Sites / Locations

  • NYU Langone Medical Center
  • Information on additional locations involved in this clinical trial contact Chelsea Therapeutics
  • Wisconsin Institute for Neurology and Sleep Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Droxidopa

Placebo

Arm Description

Droxidopa 100 mg, 200 mg, 300 mg

Placebo

Outcomes

Primary Outcome Measures

Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2013
Last Updated
December 4, 2015
Sponsor
Chelsea Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01927055
Brief Title
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
Official Title
A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to potential competition with a post-marketing study requested by FDA
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chelsea Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
Detailed Description
This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy, Pure Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Keywords
NOH, OH, PD, MSA, PAF, DBH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Droxidopa
Arm Type
Active Comparator
Arm Description
Droxidopa 100 mg, 200 mg, 300 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Droxidopa
Other Intervention Name(s)
L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS
Intervention Description
Droxidopa at 100 mg, 200 mg, 300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Mannitol
Intervention Description
Placebo to match droxidopa capsules and strength designations
Primary Outcome Measure Information:
Title
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
Description
OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.
Time Frame
Change from Randomization to Week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. 18 years and older and ambulatory (defined as able to walk at least 10 meters); 2. Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency; 3. At the Baseline visit (Visit 2), patients must demonstrate: a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1; a fall of at least 20 mmHg in their systolic blood pressure, within 3 minutes of standing; 4. Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care; Exclusion Criteria: 1. Score of 23 or lower on the mini-mental state examination (MMSE); 2. Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure; Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study; 3. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse); 4. Women who are pregnant or breastfeeding; 5. Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner; 6. Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception; 7. Untreated closed angle glaucoma; 8. Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine HTN are allowed in this study) Any significant uncontrolled cardiac arrhythmia; 9. History of myocardial infarction, within the past 2 years; 10. Current unstable angina; 11. Congestive heart failure (NYHA Class 3 or 4); 12. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ; 13. Gastrointestinal condition that may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass); 14. Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2); 15. Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2); 16. Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2); 17. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study; 18. The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann, M.D.
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Information on additional locations involved in this clinical trial contact Chelsea Therapeutics
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Wisconsin Institute for Neurology and Sleep Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

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

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