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OpenTrials
Completed

NCT Number: NCT00600873

R(+)PPX High Dose Treatment of ALS

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

R(+) pramipexole dihydrochloride monohydrate

Drug

100 mg tid orally daily

Primary outcomes

  1. decline in ALSFRS score

    Time frame: 6 months

Secondary outcomes

  1. plasma PPX levels

    Time frame: 6 months

  2. CSF PPX levels

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jan 25, 2008
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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