Status:
TERMINATED
Safety and Tolerability of Perampanel in Amyotrophic Lateral Sclerosis Patients
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Amyotrophic lateral sclerosis (ALS), the most common motor neuron disease, is a fatal progressive neurodegenerative disease affecting motor cortex, brainstem and spinal cord leading to motor neuron de...
Eligibility Criteria
Inclusion
- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed within the 3 years prior to participation as having possible, probable, or definite ALS, either sporadic or familial according to modified El Escorial criteria
- Age 18-80, able to provide informed consent, and comply with study procedures
- Participants must not have started riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are permitted in the study)
- Slow VC test equal to or greater than 50% of the predicted value
Exclusion
- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent
- Exposure to any experimental agent within 30 days of entry or at any time during the trial or enrollment in another research study within 30 days of or during this trial
- Women who are breastfeeding, who are pregnant or are planning to become pregnant
- Renal insufficiency as defined by a serum creatinine \> 1.5 times the upper limit of normal
- Hepatic insufficiency or abnormal liver function (AST and/or ALT greater than 3 times the upper limit of the normal range)
- Slow VC test less than 50% of the predicted value
- ECG finding of QTc prolongation \> 450 ms
- Patients who had already undergone tracheostomy
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03377309
Start Date
December 1 2019
End Date
July 1 2021
Last Update
September 1 2021
Active Locations (1)
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1
Johnny S. Salameh
Beirut, Lebanon, 1107 2020