R(+)PPX High Dose Treatment of ALS - Full Text View

Purpose

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.

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: R(+) pramipexole dihydrochloride monohydrate	Phase I Phase II

Genetics Home Reference related topics:

amyotrophic lateral sclerosis

MedlinePlus related topics:

Amyotrophic Lateral Sclerosis Stress

Drug Information available for:

Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months

Further study details as provided by Bennett, James P., Jr., M.D.,Ph.D.:

Primary Outcome Measures:

decline in ALSFRS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

plasma PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
CSF PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients with early ALS	Drug: R(+) pramipexole dihydrochloride monohydrate 100 mg tid orally daily

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

ALSFRS at baseline <40 FVC at baseline <70%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600873

Locations


United States, Virginia
	University of Virginia
	Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Bennett, James P., Jr., M.D.,Ph.D.

Investigators


Principal Investigator:	Ted M Burns, MD	University of Virginia

More Information

Responsible Party:	University of Virginia ( James P. Bennett Jr. M.D. Ph.D. Sponsor )
Study ID Numbers:	13023
First Received:	January 5, 2008
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00600873
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bennett, James P., Jr., M.D.,Ph.D.:

neuroprotection

oxidative stress

Study placed in the following topic categories:

Spinal Cord Diseases

Stress

Central Nervous System Diseases

Sclerosis

Degenerative motor system disease

Neurodegenerative Diseases

Motor neuron disease

Pramipexol

Dopamine

Amyotrophic lateral sclerosis

Neuromuscular Diseases

Amyotrophic Lateral Sclerosis

Lou Gehrig's disease

Motor Neuron Disease

Additional relevant MeSH terms:

Neurotransmitter Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Nervous System Diseases

Physiological Effects of Drugs

Antiparkinson Agents

Dopamine Agonists

Protective Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Bennett, James P., Jr., M.D.,Ph.D.
Information provided by:	Bennett, James P., Jr., M.D.,Ph.D.
ClinicalTrials.gov Identifier:	NCT00600873