Thalidomide in Amyotrophic Lateral Sclerosis and ALS - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Thalidomide

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hichcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Celgene Corporation

Investigators

Principal Investigator: Elijah Stommel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria