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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00140452 |
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Date of registration:
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31/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Study Using Thalidomide for the Treatment of ALS
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Scientific title:
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Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00140452 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Elijah Stommel |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion 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%
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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ALS
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Intervention(s)
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Drug: Thalidomide
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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