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Therapeutic Areas: Neurology
Disease Category: Autonomic Nervous System
Location: United States, WA

Clinical Trial Details

Overview

Research Study Summary

RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy

Purpose
This is a multi-site, placebo-controlled, double-blind, randomized-withdrawal study evaluating the durability of clinical benefit of a study drug for patients with symptomatic neurogenic orthostatic hypotension. This study has a duration of up to 36 weeks, consisting of 5 periods:
  1. Screening Period: up to 4 weeks duration;
  2. Open-Label Titration Period (Titration Period): up to 4 weeks duration;
  3. Open-Label Treatment Period (Open-Label Period): 12 weeks duration;
  4. Double-Blind Treatment Period (Double-Blind Period): 12 weeks duration;
  5. Safety Follow-Up Period: 4 weeks duration.
    To Learn more

    CW ID: 224113
    Date Last Changed: April 12, 2017

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Lundbeck NA, Ltd.
Duration
36 Weeks
Facility Type
Out-Patient
Compensation
Up to $50

Eligibility

Inclusion Criteria:
  • 18 years or older and able to stand (with or without limited assistance)
  • Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency
  • Score of at least 4 or greater on Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 (measured at Screening [Visit 1] and the first Titration Visit [Visit 2a] prior to dosing)
  • A documented drop of at least 20 millimeters of mercury (mmHg) in SBP, within 3 minutes of standing. This can either be documented in the patient history or assessed during Screening prior to the first Titration Visit (Visit 2a)
  • Additional inclusion criteria for patients taking prescribed droxidopa prior to study entry:
  • Patients who are taking prescribed droxidopa therapy are eligible to participate in the study if they meet the other inclusion criteria and also have been on a stable dose of prescribed droxidopa for at least 2 weeks prior to the Screening Visit (Visit 1). In addition, they must meet either of the following at the Screening Visit (Visit 1):
  • The patient's Visit 1 OHSA Item #1 score is ≥ 7 AND the prescribed dose is ≤ 300 mg three times daily (TID); OR
  • The patient's Visit 1 OHSA Item #1 score is ≤6 AND worsens by ≥ 2 units when retested after washing out of droxidopa for at least 3 days.
Exclusion Criteria:
  • In the investigator's opinion, the patient is not able to understand or cooperate with study procedures
  • Known or suspected alcohol or substance use disorder within the past 12 months (DSM-5 criteria)
  • Women who are pregnant or breastfeeding
  • Women of childbearing potential (WOCP) who are not using at least one method of contraception with their partner
  • Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic. Sustained is defined as the average of 3 observations each at least 10 minutes apart with the patient having been supine and at rest for at least 5 minutes prior to each measurement.
  • Untreated closed angle glaucoma
  • Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine hypertension are allowed in this study)
  • Any significant uncontrolled cardiac arrhythmia
  • History of myocardial infarction, within the past 2 years
  • Current unstable angina
  • Congestive heart failure (NYHA Class 3 or 4)
  • Diabetic autonomic neuropathy

*Additional protocol defined inclusion and exclusion criteria do apply.

More Info

For more information, contact EvergreenHealth Research Program at 425-899-5385 or EvergreenResearch@evergreenhealth.com and ask about the RESTORE study.

Contact

EvergreenHealth Research Program
12039 NE 128th Street, Suite 300
Kirkland, WA 98034
Phone: 425-899-5385

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Research Center Information:

EvergreenHealth Research Program

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