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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

Page last updated: August 23, 2015

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