Phase 3 Parkinson's Disease Trial, Completed NCT03750552 Sponsor: Theravance Biopharma Condition: Parkinson's Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT03750552) looked at a medicine called ampreloxetine compared to a placebo (a dummy treatment with no active ingredient) in people with a condition called orthostatic hypotension — where blood pressure drops when a person stands up, causing symptoms like dizziness or feeling faint. A total of 98 people started in the ampreloxetine group and 97 in the placebo group, with 90 and 95 people respectively completing the trial. The reported data shows that the main thing being measured was a change in a symptom score — specifically, how much dizziness, lightheadedness, or feeling faint improved or worsened after four weeks, rated on a scale of 0 (no symptoms) to 10 (worst possible). A lower score after treatment means fewer symptoms. The ampreloxetine group's score dropped by an average of 1.69 points, while the placebo group's score dropped by an average of 1.45 points. For the broader symptom score covering all six questions, the ampreloxetine group dropped by 1.32 points on average compared to 1.05 for placebo. A separate score measuring how symptoms affected daily activities also showed a drop of 1.22 points in the ampreloxetine group versus 0.95 in the placebo group. When participants were asked overall whether they felt better, 49 out of 94 in the ampreloxetine group and 45 out of 90 in the placebo group reported feeling improved. The reported data also shows that 33 people in the ampreloxetine group and 22 people in the placebo group experienced at least one fall during the trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Parkinson's Disease Trial, Completed

NCT03750552
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male or female and at least 30 years old.
  • You have been diagnosed with symptomatic neurogenic orthostatic hypotension (a condition where your blood pressure drops significantly when you stand up), confirmed by a tilt-table test showing a meaningful drop in blood pressure within 3 minutes of being tilted upright.
  • You experience symptoms that score at least a 4 out of 10 on a specific dizziness/lightheadedness questionnaire at the time of joining the trial.
  • If you have Parkinson's disease: you have been diagnosed according to specific recognised medical criteria (UK Parkinson's Disease Society Brain Bank Criteria, 1992).
  • If you have Multiple System Atrophy (MSA): you have a diagnosis of possible or probable MSA of either the Parkinsonian or cerebellar subtype, based on recognised medical criteria (Gilman Criteria, 2008).
  • If you have Pure Autonomic Failure (PAF): you have documented test results showing impaired autonomic (automatic nervous system) reflexes, including a specific breathing test called the Valsalva manoeuvre, carried out within the past 24 months.
  • A blood test taken after sitting quietly for 30 minutes shows your norepinephrine (a chemical in your blood) levels are above a certain threshold.

Who may not be able to join:

  • You have a known whole-body illness that affects the automatic nervous system, such as amyloidosis or certain immune system disorders.
  • You have had a bad reaction or intolerance to a certain class of medicines called NRIs or SNRIs (types of antidepressants that affect brain chemicals).
  • You are currently taking blood pressure-lowering medication for high blood pressure that is unrelated to your nervous system condition.
  • You have taken certain strong medicines that affect how your body processes drugs (called strong CYP1A2 inhibitors or inducers) within roughly the past week or longer (confirm with trial site).
  • You have recently changed the dose, type, or frequency of any medication you take for low blood pressure within the 7 days before your first visit, or you have not yet finished tapering off specific medicines (midodrine or droxidopa) at least 7 days before that visit.
  • You have had a known or suspected problem with alcohol or substance misuse within the past 12 months.
  • You have an unstable heart condition, or you have had a major heart or neurological event (such as a stroke or heart attack) in the past 6 months.
  • You have taken a type of medicine called a monoamine oxidase inhibitor (MAO-I) within the past 14 days.
  • You have untreated closed-angle glaucoma, or treated closed-angle glaucoma that an eye specialist considers a risk concern.
  • You have a significant uncontrolled irregular heartbeat.
  • You score 23 or below on a standard memory and thinking assessment called the Montreal Cognitive Assessment (MoCA).
  • You have had a heart attack in the past 6 months, or you currently have unstable chest pain (unstable angina).
  • You have moderate to severe heart failure (classified as New York Heart Association Class 3 or 4).
  • You have significantly abnormal blood test results related to liver function, kidney function, or other values that could affect your safety in the trial (confirm specific thresholds with trial site).
  • You have a history of suicidal thoughts or behaviour, as assessed using a standard clinical scale — the trial team will assess this carefully before deciding on eligibility.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Monitor, Theravance Biopharma

Australian sites

Concord Hospital, Concord, New South Wales
Royal Brisbane and Women's Hospital, Herston, Queensland
Monash Health - Clinical Trials Centre, Clayton, Victoria
The Royal Melbourne Hospital, Parkville, Victoria
Perron Institute for Neurological and Translational Science, QEII Medical Centre, Nedlands,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Theravance Biopharma
Registry
ClinicalTrials.gov
Start date
24 January 2019
Est. completion
21 July 2021

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇪🇸 Spain 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline in Orthostatic Hypotension Symptom Assessment (OHSA) Question #1 Score at Week 4

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov