Phase II Study Using Thalidomide for the Treatment of ALS
Information source: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amyotrophic Lateral Sclerosis; ALS
Intervention: Thalidomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dartmouth-Hitchcock Medical Center Official(s) and/or principal investigator(s): Elijah Stommel, Principal Investigator
Summary
The use of Thalidomide in patients with ALS who have disease progression.
Clinical Details
Official title: Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: 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
Detailed description:
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of
disease progression.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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%
Locations and Contacts
Dartmouth Hichcock Medical Center, Lebanon, New Hampshire 03756, United States
Additional Information
Starting date: February 2005
Last updated: November 20, 2007
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