Phase II Study Using Thalidomide for the Treatment of ALS

This study has been completed.
Celgene Corporation
Information provided by:
Dartmouth-Hitchcock Medical Center Identifier:
First received: August 31, 2005
Last updated: November 20, 2007
Last verified: November 2007
The use of Thalidomide in patients with ALS who have disease progression.

Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Thalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

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 [ Time Frame: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide ]

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 [ 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 ]

Estimated Enrollment: 24
Study Start Date: February 2005
Study Completion Date: November 2007
Intervention Details:
    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.
Detailed Description:
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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%
  Contacts and Locations
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Please refer to this study by its identifier: NCT00140452

United States, New Hampshire
Dartmouth Hichcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Celgene Corporation
Principal Investigator: Elijah Stommel
  More Information Identifier: NCT00140452     History of Changes
Other Study ID Numbers: ALS-001 
Study First Received: August 31, 2005
Last Updated: November 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Physiological Effects of Drugs processed this record on May 26, 2016