Phase II Study Using Thalidomide for the Treatment of ALS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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

Conditions

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Amyotrophic Lateral Sclerosis ALS

Keywords

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ALS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

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

Intervention Type DRUG

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Elijah Stommel

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dartmouth Hichcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Countries

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United States

Other Identifiers

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ALS-001

Identifier Type: -

Identifier Source: org_study_id