R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis | NCT00140218

Studies
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

NCT00140218

Sponsor

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

Status

Completed

Last Update Posted

Jan 8, 2008Estimated

Enrollment

30Actual

Phase

Phase 1Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

R(+) pramipexole dihydrochloride monohydrate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Aug 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Dec 2006Actual

First Submitted Date

Aug 30, 2005

First Submission Date that Met QC Criteria

Aug 30, 2005

First Posted Date

Sep 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2008

Last Update Posted Date

Jan 8, 2008Estimated

Name	Class
University of Pittsburgh	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
R(+) pramipexole dihydrochloride monohydrate	Drug	10 mg tid oral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence H Phillips, M.D.	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David Lacomis MD		Pittsburgh	Pennsylvania		United States
University of Virginia

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

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