Phase II Study Using Thalidomide for the Treatment of ALS
Phase 2
Completed
- Conditions
- Amyotrophic Lateral SclerosisALS
- Registration Number
- NCT00140452
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Brief Summary
The use of Thalidomide in patients with ALS who have disease progression.
- Detailed Description
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
- Secondary Outcome Measures
Name Time 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 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
Trial Locations
- Locations (1)
Dartmouth Hichcock Medical Center
🇺🇸Lebanon, New Hampshire, United States