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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
History of Changes
  Purpose

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


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
ALS
 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:

Drug Information available for: Thalidomide
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140452

Locations
United States, New Hampshire
Dartmouth Hichcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Celgene Corporation
Investigators
Principal Investigator: Elijah Stommel
  More Information

No publications provided

ClinicalTrials.gov 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:
ALS

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Thalidomide
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013