Symptomatic Neurogenic Orthostatic HypotensionPhase 3NCT01927055
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy
A Phase 3 study testing Droxidopa in people with Symptomatic Neurogenic Orthostatic Hypotension and Parkinson's Disease, run by Chelsea Therapeutics at 3 sites in United States.
Trial summary
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy
- What is being tested?
- Droxidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1;
- 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;
Who cannot join
- 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;
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Information on additional locations involved in this clinical trial contact Chelsea Therapeutics
Charlotte, North Carolina, 28277
Wisconsin Institute for Neurology and Sleep Disorders
Milwaukee, Wisconsin, 53233
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy, Pure Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Being tested
- Droxidopa, Placebo
- Keywords
- NOH, OH, PD, MSA, PAF, DBH
- Medical subject headings
- Parkinson Disease, Pure Autonomic Failure, dopamine beta hydroxylase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroxidopaDrug
Also called L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS
Droxidopa at 100 mg, 200 mg, 300 mg
PlaceboDrug
Also called Mannitol
Placebo to match droxidopa capsules and strength designations
| Study group | Role | What they receive |
|---|---|---|
| Droxidopa | Active comparator | Droxidopa 100 mg, 200 mg, 300 mg Receives: Drug: Droxidopa |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Randomization to Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Due to potential competition with a post-marketing study requested by FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptomatic Neurogenic Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horacio Kaufmann, M.D., Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927055
- Sponsor's protocol ID
- NOH401
- Status last verified
- Dec 2015
- First submitted
- 16 Aug 2013
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
- ClinicalTrials.gov ID
- NCT01927055
- Acronym / sponsor ID
- NOH401
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, Parkinson's Disease, Multiple Systems Atrophy, Pure Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
- Keywords
- NOH, OH, PD, MSA, PAF, DBH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to potential competition with a post-marketing study requested by FDA
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Chelsea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Posted 8 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Droxidopa | Active comparator | Drug: DroxidopaDroxidopa 100 mg, 200 mg, 300 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
- 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;
Key exclusion criteria (19 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DroxidopaAlso: L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPSDroxidopa at 100 mg, 200 mg, 300 mg | Drug | Droxidopa |
| PlaceboAlso: MannitolPlacebo to match droxidopa capsules and strength designations | Drug | Placebo |
Primary outcome
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
Time frame: Change from Randomization to Week 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Symptomatic Neurogenic Orthostatic Hypotension
Active, not recruitingPhase 3
Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic nOH in Participants With Multiple System Atrophy
Symptomatic Neurogenic Orthostatic Hypotension, MSA - Multiple System Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horacio Kaufmann, M.D. principal investigator
NYU Langone Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Droxidopa in people with Symptomatic Neurogenic Orthostatic Hypotension and Parkinson's Disease, run by Chelsea Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1) (time frame: Change from Randomization to Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.