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Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)


Phase 2
25 Years
80 Years
Not Enrolling
Both
Amyotrophic Lateral Sclerosis (ALS)

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Trial Information

Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)


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 starting at 100 mg (Group 1) for 6 weeks. Thereafter, the dose will be
increased every week by 50mg until reaching the dose of 400 mg/day. This treatment is
continued for 12 weeks. Thalidomide is administered in conjunction with the standard
treatment of riluzole (100mg/day).


Inclusion Criteria:



- 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 Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to evaluate the long-term safety and tolerability of thalidomide

Principal Investigator

Thomas Meyer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Charité University Hospital, Berlin, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

THL-ALS01

NCT ID:

NCT00231140

Start Date:

December 2005

Completion Date:

August 2006

Related Keywords:

  • Amyotrophic Lateral Sclerosis (ALS)
  • ALS, motor neuron disease
  • Amyotrophic Lateral Sclerosis
  • Sclerosis
  • Motor Neuron Disease

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