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Clinical Trials/NCT00140452
NCT00140452CompletedPhase 2

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

Dartmouth-Hitchcock Medical Center2 sites in 1 country24 target enrollmentStarted: February 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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%

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(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)

Investigators

Sponsor Class
Other

Study Sites (2)

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