Phase II Study Using Thalidomide for the Treatment of ALS

This study has been completed.

Sponsor:

Collaborator:

Celgene Corporation

Information provided by:

Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT00140452

First received: August 31, 2005

Last updated: November 20, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

November 20, 2007

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS [ Time Frame: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide ]

Original Primary Outcome Measures ^ICMJE

To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS

Change History

Complete list of historical versions of study NCT00140452 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS [ Time Frame: survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method ]

Original Secondary Outcome Measures ^ICMJE

To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase II Study Using Thalidomide for the Treatment of ALS

Official Title ^ICMJE

Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

Brief Summary

The use of Thalidomide in patients with ALS who have disease progression.

Detailed Description

Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Amyotrophic Lateral Sclerosis
ALS

Intervention ^ICMJE

Drug: Thalidomide

Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinically proven ALS
Disease duration less than or equal to 5 years
ALSFRS-R score equal to or greater then 30

Exclusion Criteria:

Patients with known deep venous thrombosis or hyper coagulable state will be excluded
Patients with FVC less than 80%

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00140452

Other Study ID Numbers ^ICMJE

ALS-001

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Dartmouth-Hitchcock Medical Center

Collaborators ^ICMJE

Celgene Corporation

Investigators ^ICMJE

Principal Investigator:

Elijah Stommel

Information Provided By

Dartmouth-Hitchcock Medical Center

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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