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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

August 31, 2005
November 20, 2007
February 2005
Not Provided
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 ]
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
Complete list of historical versions of study NCT00140452 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
Phase II Study Using Thalidomide for the Treatment of ALS
Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

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

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Amyotrophic Lateral Sclerosis
  • ALS
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2007
Not Provided

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%
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140452
ALS-001
No
Not Provided
Dartmouth-Hitchcock Medical Center
Celgene Corporation
Principal Investigator: Elijah Stommel
Dartmouth-Hitchcock Medical Center
November 2007

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