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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chelsea Therapeutics
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics
ClinicalTrials.gov Identifier:
NCT01927055
First received: August 16, 2013
Last updated: November 13, 2013
Last verified: November 2013

August 16, 2013
November 13, 2013
November 2013
September 2016   (final data collection date for primary outcome measure)
OHSA Item 1 [ Time Frame: Change from Randomization to Week 1 ] [ Designated as safety issue: No ]
Evaluate the duration of clinical benefits of droxidopa as demonstrated by the change in the Orthostatic Hypotension Symptom Assessment (OHSA) Item 1
Same as current
Complete list of historical versions of study NCT01927055 on ClinicalTrials.gov Archive Site
  • Falls [ Time Frame: Change from Randomization to Week 12 ] [ Designated as safety issue: Yes ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by a difference between placebo and droxidopa in patient reported falls from Randomization to the end of study visit at Week 12
  • Standing blood pressure [ Time Frame: Change from Randomization to Week 12 ] [ Designated as safety issue: No ]
    Evaluate the effect of droxidopa on standing blood pressure as demonstrated by a change from Randomization to the end of study visit at Week 12
  • Orthostatic Hypotension Questionnaire [ Time Frame: Change from Randomization to Week 12 ] [ Designated as safety issue: No ]
    Evaluate the clinical efficacy of droxidopa as demonstrated change in disease severity using the Orthostatic Hypotension Questionnaire (OHQ) composite score and individual item scores
  • Clinical Global Impression Scales [ Time Frame: Change from Randomization to Week 12 ] [ Designated as safety issue: No ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by change in the clinician recorded and patient-recorded Clinical Global Impression-Severity (CGI-S) and the Clinical Global Impression-Improvement (CGI-I) scales from Randomization to the end of study visit at Week 12
  • Boston University Activity Measure for Post-Acute Care Basic Mobility [ Time Frame: Change from Randomization to Week 12 ] [ Designated as safety issue: No ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by change in basic mobility using the Boston University Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form from Randomization to the end of study visit at Week 12
Same as current
Not Provided
Not Provided
 
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Symptomatic Neurogenic Orthostatic Hypotension
  • Parkinson's Disease
  • Multiple Systems Atrophy
  • Pure Autonomic Failure
  • Dopamine Beta Hydroxylase Deficiency
  • Drug: Droxidopa
    Droxidopa at 100 mg, 200 mg, 300 mg
    Other Name: L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS
  • Drug: Placebo
    Placebo to match droxidopa capsules and strength designations
    Other Name: Mannitol
  • Active Comparator: Droxidopa
    Droxidopa 100 mg, 200 mg, 300 mg
    Intervention: Drug: Droxidopa
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
September 2016
September 2016   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Cameron Szakacs, Ph. D. 704-973-4203 szakacs@chelseaRx.com
Contact: Charles Cram, BS 7049734213 cram@chelseaRx.com
United States
 
NCT01927055
NOH401
No
Chelsea Therapeutics
Chelsea Therapeutics
Not Provided
Principal Investigator: Horacio Kaufmann, M.D. NYU Langone Medical Center
Chelsea Therapeutics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP