Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02812147
Status:
UNKNOWN
Last Update Posted:
2019-02-15
First Post:
2016-05-25
Brief Title:
Effect of L-Dihydoxyphenylserine on Locomotion Postural Stability and Fall Risk Reduction in Parkinson Disease
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Effect of L-Dihydoxyphenylserine L-DOPS Northera a Central and Peripheral Norepinephrine Agent on Locomotion Postural Stability Balance and Fall Risk Reduction in Parkinson Disease PD
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being done to determine whether treatment with L- Dihydroxyphenylserine L-DOPS versus placebo an inactive substance that looks like study drug in addition to other Parkinson Disease PD drugs will improve balance walking and reduce risk of falls andor severity of falls in PD subjects The study is also being done to determine the effectiveness safety and tolerability of L-DOPS and whether it will decrease Freezing of Gait FOG improve apathy generalized disinterest or show a relationship between apathy and slowed movement and fall risk
Detailed Description:
Among the top three priorities presented to the National Institute of Neurological Disorders and Stroke NINDS Council 22 as final recommendations of critical needs for advancing Parkinson Disease PD research in 2014 is to develop effective treatments for dopa-resistant features of PD These features include symptoms such as gait and balance problems and freezing of gait leading to falls In order for these goals to be realized dysfunctional motor patterns in patients with gait and balance problems need to be accurately defined and assessed using body-fixed sensors and other newer computation technology to enhance sensitivity and specificity of measurement to facilitate long-term follow-up The proposed research will meet the challenge of determining appropriate intervention L-DOPS for dopa-resistant features of PD in improving gait and posture using innovative quantitative analyses derived from body-worn sensors Injuries associated with fall incidences continue to pose a significant burden to persons with Parkinsons disease PD both in terms of human suffering and economic losses Annual fall incidence rates range from 50-70 of patients with PD Recurrent falls especially are a major cause of disability in PD The resulting loss of independence and treatment costs add substantially to the healthcare expenditures in PD which was estimated to be 27 billion annually2 This number may rise substantially in the coming decades as the entire US population ages Any intervention that is cost effective at reducing fall risk could have important benefits for patients and families and for the entire healthcare system In this study we will determine whether treatment with L- Dihydroxyphenylserine L-DOPS Northera in addition to dopaminergic drugs will improve postural stability and activity of daily living and reduce fall risk andor severity of falls in PD patientsFalls early in PD within 5 years of diagnosis probably arise from slowed locomotion Slowed locomotion is corrected by dopaminergic drugs hence falls early in PD are decreased by such drugs Later in PD 5 or years after diagnosis falls recurrent falls occur despite such drugs There is evidence that falls late in PD occur because of impaired postural stability which does not respond to dopaminergic drugs or may be made worse by such drugs A single fall although serious may be only partly related or even unrelated to PD Serious fall is defined as all four limbs hit the ground the skull hits the ground or there is soft tissue or bone injury However some people with PD fall repeatedly In such patients the role of impaired postural stability was stressed Although the mechanisms underlying impaired postural stability are not well-known in patients with PD attention is focused on the noradrenergic system L-DOPS a drug that enhances norepinephrine levels in the peripheral and central nervous systems has been shown to moderate orthostatic hypotension and often improve some PD symptoms There is evidence that mechanisms related to norepinephrine centers in the basal forebrain and the locus ceruleus play a role in maintaining postural stability in activities of daily living They may play a role in preventing or ameliorating falls and freezing of gait FOG is a major problem in patients with PD who fall There is evidence that L-DOPS by improving FOG decreases risk of falls Additionally evidence indicates that L-DOPS decreases falls independent of improving FOG Apathy a major and disabling non-motor symptom of PD may be related to decreased central norepinephrine levels Apathy may be associated with slowed movements and slowed movements may contribute to falls There is evidence that L-DOPS by increasing central norepinephrine may improve apathy and this may result in a decreased risk of falls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None