R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis - Full Text View

Sponsors and Collaborators:	Bennett, James P., Jr., M.D.,Ph.D. University of Pittsburgh
Information provided by:	Bennett, James P., Jr., M.D.,Ph.D.
ClinicalTrials.gov Identifier:	NCT00140218

Purpose

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.

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

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

FVC taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months ] [ Designated as safety issue: No ]
hand dynamometry taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	August 2005
Study Completion Date:	December 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

10 mg tid oral

Detailed Description:

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%.

Eligibility

Ages Eligible for Study:	21 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140218

Locations

United States, Pennsylvania
David Lacomis MD
Pittsburgh, Pennsylvania, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

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

University of Pittsburgh

Investigators

Principal Investigator:

Lawrence H Phillips, M.D.

University of Virginia

More Information

Responsible Party:	University of Virginia ( James P. Bennett Jr. M.D. Ph.D. Sponsor )
Study ID Numbers:	11736
Study First Received:	August 30, 2005
Last Updated:	January 5, 2008
ClinicalTrials.gov Identifier:	NCT00140218
Health Authority:	United States: Food and Drug Administration

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

amyotrophic lateral sclerosis
pramipexole
oxidative stress
neuroprotection

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 January 13, 2009