Research in Movement Disorders

A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of Droxidopa therapy (RESTORE)

 [Study Sponsor: Lundbeck Pharmaceuticals]


This purpose of this study is to test the long term safety and efficacy of droxidopa therapy in adult patients with symptomatic Neurogenic Orthostatic Hypotension.

Key Inclusion Criteria:

  • 18 years or older and able to stand (with or without limited assistance)
  • Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency
  • Score of at least 4 or greater on Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 (measured at Screening [Visit 1] and the first Titration Visit [Visit 2a] prior to dosing)
  • A documented drop of at least 20 millimeters of mercury (mmHg) in SBP, within 3 minutes of standing. This can either be documented in the patient history or assessed during Screening prior to the first Titration Visit (Visit 2a)

Additional inclusion criteria for patients taking prescribed droxidopa prior to study entry:

  • Patients who are taking prescribed droxidopa therapy are eligible to participate in the study if they meet the other inclusion criteria and also have been on a stable dose of prescribed droxidopa for at least 2 weeks prior to the Screening Visit (Visit 1). In addition, they must meet either of the following at the Screening Visit (Visit 1):
  • The patient's Visit 1 OHSA Item #1 score is ≥ 7 AND the prescribed dose is ≤ 300 mg three times daily (TID); OR
  • The patient's Visit 1 OHSA Item #1 score is ≤6 AND worsens by ≥ 2 units when retested after washing out of droxidopa for at least 3 days
  • This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT02586623

Effect of LY3154207 on Cognition in Mild-to-Moderate Parkinson’s Disease Dementia (PRESENCE)

[Study Sponsor: Eli Lilly & Company]
 

The purpose of this study is to test the effects of LY3154207 on Cognition in Mild to moderate Parkinson’s Disease Dementia (PDD).

Key Inclusion Criteria:

  • Have Idiopathic Parkinsons's Disease (PD) per MDS criteria with at least 2 years of PD symptoms.
  • Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment.
  • Have a score on the MoCA of 10 - 23.
  • Are Modified Hoehn and Yahr Stages 1 - 4.
  • Have a blood pressure (BP) or pulse rate at screening and randomization, as determined by three sequential BP/pulse rate measurements in a seated position:

Participants <60 years old:

  • A mean systolic BP less than or equal to 140 millimeters of mercury (mmHg), a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal 90 beats/minute in a seated position.
  • Each of the 3 systolic BP measurement must be less than 180 mmHg

Participants ≥60 years old:

  1. A mean systolic BP less than or equal to 150 mmHg, a mean diastolic BP less than or equal to 90 mmHg and a mean pulse rate less than or equal to 90 beats/min in a seated position.
  2. Each of the 3 systolic BP measurement must be less than 180 mmHg

 

  • If on anti-parkinsonian agents, participants must be on stable dosage for at least 4 weeks prior to baseline.
  • If on anti-hypertensive medications, participants must be on stable dosage for at least 3 months prior to screening.
  • All participants must have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to screening, baseline, day 7, day 42, day 84 and follow-up.
     

This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT03305809

 

For questions regarding the above studies, please contact:

 

University of Arizona, Health Sciences, Department of Neurology
1501 N. Campbell Avenue
Tucson, AZ 85724