Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)

NCT03567447 | Unknown Phase 2 FDA Drug

• 1 other identifier: 16-0200-80-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a Phase II single center, double-blind, randomized, placebo-controlled, efficacy study. Subjects will complete six visits. The first will be a screening visit. There will be four assessment visits: baseline, 2 weeks after the double-blinded trial begins, the end of the blinded trial, and after 4 weeks of washout. There will also be an additional randomization and medication dispensing visit immediately following the dose optimization period and preceding the double-blinded trial.

Conditions

Parkinson Disease; Falls Patient

Keywords

Parkinsons Disease; PD; Patient Falls; Neurogenic Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Change in number of falls

  The effect of L-DOPS on falls will be assessed by measuring the number of falls during balance perturbation testing.

  Study weeks 2, 4 and 8

Secondary Outcomes (1)

• Change in objective and subjective measures of Balance

  Study weeks 2, 4 and 8

Study Arms (2)

Treatment group

EXPERIMENTAL

This group will receive droxidopa 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.

Drug: Droxidopa; Other: Placebo

Non treatment group

PLACEBO COMPARATOR

This group will receive placebo appearing to be 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.

Other: Placebo

Interventions

Droxidopa DRUG

starting with 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.

Also known as: NORTHERA

Treatment group

Placebo OTHER

appearing to be 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.

Non treatment group; Treatment group

Eligibility Criteria

• Age: 30 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
• Subject is male or female and is ≥ 30 and ≤ 83 years of age.
• Parkinson's diagnosis with history of falls or gait difficulty.
• Subject demonstrates neurogenic orthostatic hypotension (drop of 20 mm/Hg Systolic or 10 mm/Hg diastolic or both within 3 min of standing)
• Fell more than once in past year.
• Montreal Cognitive Assessment (MoCA) score ≥ 21.
• Stable dose of levodopa, dopamine agonist, amantadine, and/or monoamine oxidase B inhibitor, i.e. unchanged for 1 month.
• Subject is ambulatory and able to walk ≥ 10 meters with/without the use of an assistive device.

You may not qualify if:

• Subject has a clinical diagnosis of an atypical Parkinsonism
• Subject has a clinical diagnosis of PD that is suspicious to the investigator as being a possible case of atypical Parkinson's
• History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study; history of major depressive disorder in the past year, or current major depressive episode
• Patients with systolic BP ≤70 mm/hg
• Subjects with a history of coronary artery disease or congestive heart failure
• Participation in another investigational drug or device study in during the 60 days prior to the Screening Visit
• Treatment with any anti-hypertensive medications
• Treatment with any anti-spasmodic medications
• Treatment with medications intended to elevate blood pressure
• Treatment with non-specific monoamine oxidase (MAO) inhibitors

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• H. Lundbeck A/S: collaborator
• Arizona State University: collaborator

Study Sites (1)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Droxidopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Abraham Lieberman, MD

  Barrow Neurological Insitute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret McCauley

CONTACT

602-406-8134; Margaret.McCauley@dignityhealth.org

Pam Dewey

CONTACT

602-406-8252; pam.dewey@dignityhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II single center, double-blind, randomized, placebo-controlled, efficacy study

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 25, 2018
• Study Start: August 17, 2018
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)