NCT00600873

Brief Summary

R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

January 5, 2008

Last Update Submit

September 10, 2010

Conditions

Amyotrophic Lateral Sclerosis

Keywords

neuroprotectionoxidative stress

Outcome Measures

Primary Outcomes (1)

  • decline in ALSFRS score

    6 months

Secondary Outcomes (2)

  • plasma PPX levels

    6 months

  • CSF PPX levels

    6 months

Study Arms (1)

1

EXPERIMENTAL

patients with early ALS

Drug: R(+) pramipexole dihydrochloride monohydrate

Interventions

R(+) pramipexole dihydrochloride monohydrateDRUG

100 mg tid orally daily

1

Eligibility Criteria

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

You may qualify if:

  • definite ALS no prior exposure to R(+)PPX

You may not qualify if:

  • ALSFRS at baseline \<40 FVC at baseline \<70%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Wang H, Larriviere KS, Keller KE, Ware KA, Burns TM, Conaway MA, Lacomis D, Pattee GL, Phillips LH 2nd, Solenski NJ, Zivkovic SA, Bennett JP Jr. R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS. Amyotroph Lateral Scler. 2008 Feb;9(1):50-8. doi: 10.1080/17482960701791234.

    PMID: 18270879RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ted M Burns, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Expanded Access
Yes

Study Record Dates

First Submitted

January 5, 2008

First Posted

January 25, 2008

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

January 1, 2009

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

US(1)