Phase II Study Using Thalidomide for the Treatment of ALS

Phase 2CompletedNCT00140452

Dartmouth-Hitchcock Medical Center24 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis ALS

Interventions

ThalidomideDRUG

Thalidomide will start at a dose of 100mg/day, dose escalated every 2 weeks by 100mg/day to a target dose of 400mg/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (1)

Dartmouth Hichcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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