Phase II Study Using Thalidomide for the Treatment of ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140452
• Other study ID #: ALS-001
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: November 20, 2007
• Start date: February 2005
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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%

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Dartmouth Hichcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
Secondary	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		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