Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2021
• Main ID: NCT03446807
• Date of registration: 20/02/2018
• Prospective Registration: Yes
• Primary sponsor: Loma Linda University
• Public title: Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism
• Scientific title: Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism
• Date of first enrolment: December 2021
• Target sample size: 32
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03446807
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Khashayar Dashtipour, MD, PhD

• Name: Principal Investigator

• Name: Khashayar Dashtipour, M.D. Ph.D.
• Affiliation: Loma Linda University Health

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age of 50 years or older.

- Clinical diagnosis of Parkinsons Disease or Atypical Parkinsonism (including multiple
system atrophy (MSA), PSP)

- Fluent in English

- Reported fatigue and must have a mean VAFS score of 4 or more at baseline

- Written informed consent

Exclusion Criteria:

- Inability to understand or cooperate with study procedures

- Alcohol or substance use disorder within the past 12 months (as per Diagnostic and
Statistical Manual of Mental Disorders (DSM-5) criteria)

- Women who are pregnant or breastfeeding

- Women of childbearing potential (WOCP) as indicated by one of the following:

- Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg
diastolic. Sustained is defined as the average of 3 observations each at least 10
minutes apart with the patient having been supine and at rest for at least 5 minutes
prior to each measurement

- Untreated closed angle glaucoma

- Diagnosis of hypertension that requires treatment with antihypertensive medications

- Any significant uncontrolled cardiac arrhythmia

- History of myocardial infarction, within the past 2 years

- Current unstable angina

- Congestive heart failure (NYHA Class 3 or 4)

- Diabetic autonomic neuropathy

- 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

- Gastrointestinal condition that may affect the absorption of Investigational Medicinal
Product (e.g. ulcerative colitis, gastric bypass)

- Any major surgical procedure within 30 days prior to the first titration visit.

- Currently receiving any investigational drug or have received an investigational drug
within 28 days prior to the first titration visit

- 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

- Dementia or non-treated depression

- Subjects who have a mean VAFS score of less than 4 at baseline

- Vulnerable populations

- Uncontrolled intercurrent illnesses including, but not limited to severe lung disease,
ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, symptomatic cardiac arrhythmia, and situations that would limit compliance
with study requirements will be excluded

- Orthostatic hypotension (OH)



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple System Atrophy

Parkinson Disease

Progressive Supranuclear Palsy

Intervention(s)

Drug: Droxidopa

Drug: Placebo Oral Tablet

Primary Outcome(s)

Efficacy of Droxidopa on fatigue in subjects with Parkinsonism as determined by completion of Visual Analogue Fatigue Scale (VAFS) [Time Frame: Change between baseline and 12 weeks]

Efficacy of Droxidopa on fatigue in subjects with Parkinsonism as determined by completion of Visual Analogue Fatigue Scale (VAFS) [Time Frame: Change between 18 weeks and 28 weeks]

Efficacy of Droxidopa on fatigue in subjects with Parkinsonism as determined by completion of Visual Analogue Fatigue Scale (VAFS) [Time Frame: Week 29]

Secondary Outcome(s)

Efficacy of Droxidopa on motor and non-motor symptoms of Parkinsonism as determined by the Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: Change between baseline and 12 weeks]

Efficacy of Droxidopa on motor and non-motor symptoms of Parkinsonism as determined by the Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: Change between 18 weeks and 28 weeks]

Efficacy of Droxidopa on motor and non-motor symptoms of Parkinsonism as determined by the Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: Week 29]

Secondary ID(s)

5170406

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S