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Completed

NCT Number: NCT00140218

R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.

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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

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

David Lacomis MD, Pittsburgh, Pennsylvania, United States

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About this study

This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)

Exclusion criteria

  • ALS duration >3 years advanced ALS with survival predicted <6 months dementia (MMSE<22) prior exposure to R(+) pramipexole orthostatic hypotension >30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values

Treatment and study plan

R(+) pramipexole dihydrochloride monohydrate

Drug

10 mg tid oral

Primary outcomes

  1. ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment

    Time frame: -3 -2 -1 0 1 2 3 4 5 6 months

Secondary outcomes

  1. FVC taken each month

    Time frame: -3 -2 -1 0 1 2 3 4 5 6 months

  2. hand dynamometry taken each month

    Time frame: -3 -2 -1 0 1 2 3 4 5 6

Sponsors and collaborators

Lead sponsor

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

Indiv

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

Important dates

Study start
2005
Primary completion
2007
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Jan 8, 2008

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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