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Completed

NCT Number: NCT00140452

Phase II Study Using Thalidomide for the Treatment of ALS

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

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Key information

Conditions

Amyotrophic Lateral Sclerosis ALS Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dartmouth Hichcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

thalidomide

Drug

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 outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Celgene Corporation

Registry information

Official study title

Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

Important dates

Study start
2005
Study completion
2007
First posted
Sep 1, 2005
Registry last updated
Nov 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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