Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00738062
• Date of registration: 19/08/2008
• Prospective Registration: No
• Primary sponsor: Chelsea Therapeutics
• Public title: Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) NOH303
• Scientific title: An Open-label Study, to Assess the Long-term Safety and Clinical Benefit of Droxidopa in Subjects With PAF, Dopamine Beta Hydroxylase Deficiency or Non-diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension
• Date of first enrolment: January 2008
• Target sample size: 103
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00738062
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Christopher J. Mathias, MD
• Affiliation: Imperial School of Medicine

• Name: Horacio Kaufmann Kaufmann, MD
• Affiliation: NYU School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

To be eligible for inclusion, each patient must fulfill the following criteria:

- Participated in Droxidopa Protocol 302;

- 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:

Patients are not eligible for this study if they fulfill one or more of the following
criteria:

- Currently taking ephedrine or midodrine;

- Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days
prior to their study entry visit (Visit 1).

- Currently taking anti-hypertensive medication;

* The use of short-acting anti-hypertensive medications at bedtime is permitted.

- Currently taking tri-cyclic antidepressant medication or other norepinephrine
re-uptake inhibitors;

- Have changed dose, frequency and or type of prescribed medication, within two weeks of
study start (excluding ephedrine and midodrine);

- History of more than moderate alcohol consumption;

- History of known or suspected drug or substance abuse;

- Women of childbearing potential who are not using a medically accepted contraception;

- Reproductive potential:

- Female subjects should be either post-menopausal (amenorrhea for at least 12
consecutive months), surgically sterile, or women of child-bearing potential
(WOCP) who are using or agree to use acceptable methods of contraception.

- Acceptable contraceptives include intrauterine devices (IUDs), hormonal
contraceptives (oral, depot, patch or injectable) and double barrier methods such
as condoms or diaphragms with spermicidal gel or foam.

- For WOCP a urine pregnancy test must be conducted at each study visit.

- WOCP must be advised to use acceptable contraceptives throughout the study period
and for 30 days after the last dose of investigational product.

- If hormonal contraceptives are used they should be taken according to the package
insert.

- WOCP who are not currently sexually active must agree to use acceptable
contraception, as defined above, if they decide to become sexually active during
the period of the study and for 30 days after the last dose of investigational
product.

- Sexually active males whose partner is a WOCP and who do not agree to use condoms for
the duration of the study and for 30 days after the last dose;

- Women who are pregnant or breast feeding;

- Known or suspected hypersensitivity to the study medication or any of its ingredients;

- Pre-existing sustained severe hypertension (BP 180/110 mmHg in the sitting position);

- Have atrial fibrillation or, in the investigator's opinion, have any other significant
cardiac arrhythmia;

- Any other significant systemic, hepatic, cardiac or renal illness;

- Diabetes mellitus or insipidus;

- Have a history of closed angle glaucoma;

- Have a known or suspected malignancy;

- Have a serum creatinine level > 130 umol/L;

- Patients with known gastrointestinal illness or other gastrointestinal disorder that
may, in the investigator's opinion, affect the absorption of study drug;

- In the investigator's opinion, have clinically significant abnormalities on clinical
examination or laboratory testing;

- In the investigator's opinion, are unable to adequately co-operate because of
individual or family situation;

- In the investigator's opinion, are suffering from a mental disorder that interferes
with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major
depression, dementia;

- Are not able or willing to comply with the study requirements for the duration of the
study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Diabetic Autonomic Neuropathy

Multiple System Atrophy

Neurogenic Orthostatic Hypotension

Dopamine Beta Hydroxylase Deficiency

Intervention(s)

Drug: Placebo

Drug: Droxidopa

Primary Outcome(s)

Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ) [Time Frame: 14 days]

Secondary Outcome(s)

Change in Orthostatic Hypotension Daily Activities (OHDAS) Score [Time Frame: 14 days]

Patient Reported Clinical Global Impression - Improvement [Time Frame: 14 days]

Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score [Time Frame: 14 days]

Clinician Recorded Clinical Global Impression - Severity [Time Frame: 14 days]

Clinician Rated Clinical Global Impressions - Improvement [Time Frame: 14 days]

Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing [Time Frame: 14 days]

Patient Reported Clinical Global Impression - Severity [Time Frame: 14 days]

Secondary ID(s)

Droxidopa NOH303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00738062