NCT00140218

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

January 8, 2008

Status Verified

January 1, 2008

Enrollment Period

1.4 years

First QC Date

August 30, 2005

Last Update Submit

January 5, 2008

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosispramipexoleoxidative stressneuroprotection

Outcome Measures

Primary Outcomes (1)

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

    -3 -2 -1 0 1 2 3 4 5 6 months

Secondary Outcomes (2)

  • FVC taken each month

    -3 -2 -1 0 1 2 3 4 5 6 months

  • hand dynamometry taken each month

    -3 -2 -1 0 1 2 3 4 5 6

Interventions

R(+) pramipexole dihydrochloride monohydrateDRUG

10 mg tid oral

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

David Lacomis MD

Pittsburgh, Pennsylvania, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

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

  • Lawrence H Phillips, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

August 1, 2005

Primary Completion

January 1, 2007

Study Completion

December 1, 2006

Last Updated

January 8, 2008

Record last verified: 2008-01

Locations

US(2)