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

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ClinicalTrials.gov Identifier: NCT01927055
Recruitment Status : Terminated (Due to potential competition with a post-marketing study requested by FDA)
First Posted : August 22, 2013
Results First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Chelsea Therapeutics

Brief Summary:
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Condition or disease Intervention/treatment Phase
Symptomatic Neurogenic Orthostatic Hypotension Parkinson's Disease Multiple Systems Atrophy Pure Autonomic Failure Dopamine Beta Hydroxylase Deficiency Drug: Droxidopa Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Study Start Date : November 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: Droxidopa
Droxidopa 100 mg, 200 mg, 300 mg
Drug: Droxidopa
Droxidopa at 100 mg, 200 mg, 300 mg
Other Name: L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS

Placebo Comparator: Placebo
Drug: Placebo
Placebo to match droxidopa capsules and strength designations
Other Name: Mannitol

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927055

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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, North Carolina
Information on additional locations involved in this clinical trial contact Chelsea Therapeutics
Charlotte, North Carolina, United States, 28277
United States, Wisconsin
Wisconsin Institute for Neurology and Sleep Disorders
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Chelsea Therapeutics
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Principal Investigator: Horacio Kaufmann, M.D. NYU Langone Medical Center
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Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT01927055    
Other Study ID Numbers: NOH401
First Posted: August 22, 2013    Key Record Dates
Results First Posted: January 8, 2016
Last Update Posted: January 8, 2016
Last Verified: December 2015
Keywords provided by Chelsea Therapeutics:
Additional relevant MeSH terms:
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Parkinson Disease
Hypotension, Orthostatic
Multiple System Atrophy
Shy-Drager Syndrome
Pure Autonomic Failure
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents