Phase II Study Using Thalidomide for the Treatment of ALS

Dartmouth Health

Status and phase: Completed; Phase 2

Conditions: ALS; Amyotrophic Lateral Sclerosis

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00140452

ALS-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)