Back to resultsPhase II Study Using Thalidomide for the Treatment of ALS
Primary Purpose
Amyotrophic Lateral Sclerosis, ALS
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS
Eligibility Criteria
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%
Sites / Locations
- Dartmouth Hichcock Medical Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00140452
First Posted
August 31, 2005
Last Updated
November 20, 2007
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00140452
Brief Title
Phase II Study Using Thalidomide for the Treatment of ALS
Official Title
Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, ALS
Keywords
ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elijah Stommel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth Hichcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Study Using Thalidomide for the Treatment of ALS
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