Clinical Trial: Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Brief Summary: To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)
Detailed Summary:
This is a multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention study with a duration of up to 36 weeks, consisting of 5 periods:
Screening Period: up to 4 weeks duration; Open-Label Titration Period (Titration Period): up to 4 weeks duration; Open-Label Treatment Period (Open-Label Period): 12 weeks duration; Double-Blind Treatment Period (Double-Blind Period): 12 weeks duration; Safety Follow-Up Period: 4 weeks duration
Sponsor: Lundbeck Northera Ltd.
Current Primary Outcome: Time-to-intervention [ Time Frame: Randomization to week 12 ]
Need for intervention is defined as meeting ANY of the following criteria during the Double-Blind Period:
- Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 ≥2 unit worsening from Randomization (Visit 6) AND lack of efficacy as judged by the investigator; OR
- OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at 2 consecutive visits; OR
- OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at the visit before early discontinuation; OR
- Patient stops IMP or withdraws from study for patient-reported lack of efficacy.
The timing of the need for intervention in the above criteria is defined as the first occurrence of a worsening of OHSA Item #1 by ≥ 2 units or when the patient stops taking IMP or withdraws due to a patient-reported lack of efficacy.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to all cause discontinuation [ Time Frame: Randomization to week 12 ]
- Mean change in OHSA item #1 score from Randomization (Visit 6) to all post-Randomization visits [ Time Frame: Randomization to week 12 ]
- Mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from Randomization (Visit 6) to all post-Randomization visits [ Time Frame: Randomization to week 12 ]
- Clinician-rated Clinical Global Impressions - Severity (CGI-S) at all post-Randomization visits (Visits 7-12) [ Time Frame: Randomization to week 12 ]
- Patient-rated CGI-S at all post-Randomization visits (Visits 7-12) [ Time Frame: Randomization to week 12 ]
- Cumulative number of patients who need intervention over the 12-week Double-Blind Treatment period [ Time Frame: Randomization to week 12 ]
Original Secondary Outcome: Same as current
Information By: Lundbeck Northera Ltd.
Dates:
Date Received: October 23, 2015
Date Started: February 2016
Date Completion: March 2021
Last Updated: February 17, 2017
Last Verified: February 2017