NCT00070928

Brief Summary

The purpose of this trial is to test the short-term effectiveness of valerian, a medicinal herb, to improve sleep in patients with Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 26, 2006

Status Verified

July 1, 2006

First QC Date

October 9, 2003

Last Update Submit

July 25, 2006

Conditions

InsomniaParkinson's Disease

Keywords

Sleep

Interventions

valerianDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease
  • Willing to undergo overnight, in-lab polysomnography
  • Sufficient literacy to allow completion of sleep logs
  • Stable doses and timing of all Parkinsonian medications during the course of the trial

You may not qualify if:

  • Dementia
  • Parkinsonism secondary to toxic, infectious, or other medical conditions
  • History of stroke, cerebellar disease, or progressive supranuclear palsy
  • History of liver or renal disease
  • History of duodenal or bladder obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Medical School/Wesley Woods Hospital

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersParkinson Disease

Interventions

Valeriana extract

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Donald L. Bliwise, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 9, 2003

First Posted

October 13, 2003

Study Start

September 1, 2000

Study Completion

June 1, 2006

Last Updated

July 26, 2006

Record last verified: 2006-07

Locations

US(1)