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

Parkinson's Disease Clinical Trial

Official title:

A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01927055
• Other study ID #: NOH401
• Status: Terminated
• Phase: Phase 3
• First received: August 16, 2013
• Last updated: December 4, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: Chelsea Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Dopamine Beta Hydroxylase Deficiency
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Multiple Systems Atrophy
• Parkinson Disease
• Parkinson's Disease
• Pure Autonomic Failure
• Shy-Drager Syndrome
• Symptomatic Neurogenic Orthostatic Hypotension

Intervention

Drug:
• Droxidopa
Droxidopa at 100 mg, 200 mg, 300 mg
• Placebo
Placebo to match droxidopa capsules and strength designations

Locations

Country	Name	City	State
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	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Randomization to Week 1	No