CLINICAL TRIALS FOR NON-PHARMACEUTICAL INTERVENTIONS

Click on each drug to learn more details, including links to clinical trial opportunities.

DROXIDOPA (Northera) ** FDA Approved

A Phase 4 clinical trial in patients with neurogenic orthostatic hypotension (nOH) is underway.
For Phase 4 clinical trial details See: https://clinicaltrials.gov/ct2/show/NCT02586623

Droxidopa was approved by the FDA in the USA in 2014 and is now sold under the brand name Northera. Although the drug may now be prescribed to MSA patients, additional Phase 4 clinical trials are currently underway to measure its long-term effects.

Droxidopa is intended to treat the symptom neurogenic orthostatic hypotension (low blood pressure when standing) that 80% of MSA patients suffer from.

For historical Phase 3 clinical trial details See: https://clinicaltrials.gov/ct2/show/NCT01132326

Related Posters:

November 2020: Effect of the Initial Maintenance Dose of Droxidopa on Treatment Persistence in Patients With Neurogenic Orthostatic Hypotension

Related Videos:

October 2014: VIDEO: Novel Therapeutic Approaches in MSA and Drug Trial Updates

Related Articles:

September 29, 2021: Lupin Launches Droxidopa Capsules in the United States

June 2017: Droxidopa for symptomatic neurogenic orthostatic hypotension: what can we learn?

June 2017: Patient-Reported Outcomes in a Prospective Real-World Study of Droxidopa for the Treatment of Neurogenic Orthostatic Hypotension

September 2014: How can patients obtain Northera (droxidopa)?

September 2014: Lundbeck’s Northera Now Available Through Specialty Pharmacy

NOTE: All of the above information is intended to assist MSA patients and their families in having a conversation with doctors, none of it should be considered medical advice or endorsements of any particular drugs or therapies. Always consult a licensed medical practitioner for expert care.

AMPRELOXETINE (TD-9855) ** Phase 3 Clinical Trial Completed 2021

A Phase 3 clinical trial in patients with neurogenic orthostatic hypotension (nOH) has completed underway.
For historical Phase 3 clinical trial details See: https://clinicaltrials.gov/ct2/show/NCT03750552

Ampreloxetine is a novel norepinephrine and serotonin reuptake inhibitor intended to treat the symptom “neurogenic orthostatic hypotension” or NOH (low blood pressure when standing) that 80% of MSA patients suffer from.

For historical Phase 2 clinical trial details See: https://clinicaltrials.gov/ct2/show/NCT02705755

Related Articles:

September 2021: Theravance Biopharma, Inc. announces top-line results from a Phase 3 study of Ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension

July 2019: Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Oral Presentation at 32nd European Neurology Congress

June 2019: Theravance Biopharma Reports New Data from Phase 2 Study of Ampreloxetine (TD-9855) in Presentation at 2019 International Association of Parkinsonism and Related Disorders (IAPRD) World Congress

March 2019: Theravance Biopharma Announces Ampreloxetine (TD-9855) Phase 2 Study Results Selected for Oral Presentation at 32nd European Neurology Congress

January 2019: Theravance Biopharma Announces First Patient Dosed in Registrational Phase 3 Study of Ampreloxetine (TD-9855) for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension

October 2018: Preclinical cardiovascular sympathoexcitatory effects of TD-9855, a novel norepinephrine transporter (NET) inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure

August 2018: Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension

April 2017: Two New Studies Open for Patients with MSA

December 2014: Preclinical to clinical translation of CNS transporter occupancy of TD-9855, a novel norepinephrine and serotonin reuptake inhibitor


NOTE: All of the above information is intended to assist MSA patients and their families in having a conversation with doctors, none of it should be considered medical advice or endorsements of any particular drugs or therapies. Always consult a licensed medical practitioner for expert care.

ATOMEXETINE (Strattera) ** Phase 2 Clinical Trial Completed 2021

A Phase 2 clinical trial in MSA patients is completed.
For historical Phase 2 clinical trial details See: https://clinicaltrials.gov/ct2/show/NCT02796209

Sold under the brand name Strattera, Atomexetine is a norepinephrine (noradrenaline) reuptake inhibitor approved for the treatment of attention deficit hyperactivity disorder (ADHD).

The Phase 2 clinical trial aims to evaluate the compound as a potential treatment of the symptom neurogenic orthostatic hypotension (low blood pressure when standing) that 80% of MSA patients suffer from.

Related Articles:

March 2018: Evaluating the effectiveness of atomoxetine for the treatment of primary orthostatic hypotension in adults

October 2017: VIDEO: Treatment of Neurogenic Orthostatic Hypotension in MSA – A New Study

April 2017: Two New Studies Open for Patients with MSA

September 2014: Efficacy of Atomoxetine Versus Midodrine for the Treatment of Orthostatic Hypotension in Autonomic Failure


NOTE: All of the above information is intended to assist MSA patients and their families in having a conversation with doctors, none of it should be considered medical advice or endorsements of any particular drugs or therapies. Always consult a licensed medical practitioner for expert care.

CERC-301

A Phase 1 clinical trial in patients with neurogenic orthostatic hypotension (nOH) was previously completed.
For historical Phase 1 clinical trial details See: CERC-301 publications

CERC-301 is a selective NR2B specific NMDA receptor antagonist being developed for the treatment of Neurogenic Orthostatic Hypotension (nOH) associated with neurodegenerative diseases such as Parkinson’s Disease, Multiple System Atrophy and Pure Autonomic Failure.

Related Articles:

July 2019: Cerecor Announces Positive Final Results of CERC-301 in the Treatment of Neurogenic Orthostatic Hypotension (OH)

April 2019: Cerecor Announces Positive Interim Results of CERC-301 in the Treatment of Neurogenic Orthostatic Hypotension (nOH)

August 2018: Cerecor Announces First Patient Enrolled in Phase I Trial for Neurogenic Orthostatic Hypotension (nOH) in Parkinson’s Disease


NOTE: All of the above information is intended to assist MSA patients and their families in having a conversation with doctors, none of it should be considered medical advice or endorsements of any particular drugs or therapies. Always consult a licensed medical practitioner for expert care.

Efficacy of NOH Treatments - Clinical Study in Progress *

The objective of this study is to find a more objective and accurate way to assess the efficacy of the treatment for neurogenic orthostatic hypotension. For this purpose, the investigators will use an activity monitor to determine the amount of time patients spend in the upright position (standing and walking; upright time) during 1 week of placebo (a pill with no active ingredients) and 1 week of their regular medication for orthostatic hypotension (midodrine or atomoxetine at their usual doses).

For clinical trial details See: https://www.clinicaltrials.gov/ct2/show/NCT04782830

Related Posters:

NOTE: All of the above information is intended to assist MSA patients and their families in having a conversation with doctors, none of it should be considered medical advice or endorsements of any particular drugs or therapies. Always consult a licensed medical practitioner for expert care.

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