Phase II Study Using Thalidomide for the Treatment of ALS - Full Text View

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center Celgene Corporation
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00140452

Purpose

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

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis ALS	Drug: Thalidomide	Phase II

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

Drug Information available for: Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

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:

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

unaffiliated

More Information

Study ID Numbers:	ALS-001
Study First Received:	August 31, 2005
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00140452
Health Authority:	United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:

ALS

Study placed in the following topic categories:

Amyotrophic lateral sclerosis
Thalidomide
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases

Lou Gehrig's disease
Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 13, 2009