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

NCT ID: NCT01927055

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

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.

Conditions

Symptomatic Neurogenic Orthostatic Hypotension; Parkinson's Disease; Multiple Systems Atrophy; Pure Autonomic Failure; Dopamine Beta Hydroxylase Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Droxidopa

Droxidopa 100 mg, 200 mg, 300 mg

Group Type: ACTIVE_COMPARATOR

Droxidopa

Intervention Type: DRUG

Droxidopa at 100 mg, 200 mg, 300 mg

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match droxidopa capsules and strength designations

Interventions

Droxidopa

Droxidopa at 100 mg, 200 mg, 300 mg

Intervention Type: DRUG

Placebo

Placebo to match droxidopa capsules and strength designations

Intervention Type: DRUG

Other Intervention Names

L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS; Mannitol

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chelsea Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Horacio Kaufmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Medical Center

New York, New York, United States

Information on additional locations involved in this clinical trial contact Chelsea Therapeutics

Charlotte, North Carolina, United States

Wisconsin Institute for Neurology and Sleep Disorders

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

NOH401

Identifier Type: -

Identifier Source: org_study_id