Status:
TERMINATED
Pilot-Study of Thalidomide in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief Summary
Neuroinflammation has recently emerged as a significant contributor to motor neuron damage. ALS tissue is characterized by inflammatory changes that are observed in both sporadic and familial ALS and ...
Detailed Description
Study drug will be provided as 50 mg tablets. Patients will be instructed to take 2 tablets orally once a day during the evening at least 60 minutes after a meal. Thalidomide will be administered star...
Eligibility Criteria
Inclusion
- patients aged 25 and 80 years
- female patients who are either postmenopausal for at least 24 month or who are willing and able to practice the methods of contraception following the Pharmion-Risk Managment Program (PRMP)
- Male patients who are willing and able to practice the methods of contraception along with their female partners of childbearing potential following the PRMP
- Clinical diagnosis of probable and definite ALS
- Sporadic or familial ALS
- Onset of pareses for no more than 4 years
- Vital capacity equal to or more than 65% of the predicted value
- Treatment with riluzole 100mg/day
- Patients who are willing to give informed consent
Exclusion
- pregnancy or breast feeding
- female patients who are unwilling or unable to practice the methods of contraception following the Pharmion-Risk Managment Program (PRMP)
- Male patients who are willing and able to practice the methods of contraception along with their female partners of childbearing potential following the PRMP
- Patients unlikely to comply with the PRMP and other study requirements
- Patients with significant sensory abnormalities, dementia, uncompensated medical illnesses and psychiatric disorders
- Laboratory abnormalities consistent with clinically significant cardiovascular, respiratory, haematological, metabolic, hepatic and renal disease
- Infectious disease including HIV, hepatitis B and C
- monoclonal gammopathy of unknown significance (MGUS)
- History of substance abuse within the past year
- History of recurrent thrombosis
- Continuous non-invasive ventilation (ventilation-free interval equal to or less than 2 hours daily)
- Tracheotomy and invasive ventilation
- Treatment with investigational drug within 3 months prior to screening
- patients with clinically signifikant sensory polyneuropathy (inflammatory neuropathy cause and treatment sensory sum score - ISS ≥ 2)
- patients with sleep disorder (Epworth Sleeping Scale-ESS ≥ 10)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00231140
Start Date
December 1 2005
End Date
August 1 2006
Last Update
January 19 2007
Active Locations (1)
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1
Charite University Hospital, Berlin, Germany
Berlin, State of Berlin, Germany, 13353