Status:
TERMINATED
Arimoclomol in Amyotropic Lateral Sclerosis - Open Label Extension Trial
Lead Sponsor:
ZevraDenmark
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multicenter, non-randomized, open label trial, to assess long term safety and efficacy of Arimoclomol in subjects with Amyotrophic Lateral Sclerosis (ALS) who have completed the ORARIALS-01 trial.
Detailed Description
The planned duration of the open-label trial was 152 weeks, but the trial was terminated early as a consequence of the results of ORARIALS-01 which did not meet any of its efficacy endpoints. Therefor...
Eligibility Criteria
Inclusion
- Subject is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures, or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures
- Subject has completed the ORARIALS-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or PAV or has completed the 76 weeks randomized treatment period)
- Subject completed ORARIALS-01 while on treatment, where on treatment is defined as having taken the last dose of IMP within 2 weeks of the End of Trial visit (whether at week 76 or prior)
Exclusion
- Known or suspected allergy or intolerance to the IMP (Arimoclomol or constituents)
- Exposure to any other investigational treatment, advanced therapy medicinal product or use of any other prohibited concomitant medications
- Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. Pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication.
- Any of the following medically significant conditions:
- Clinically significant renal or hepatic disease OR clinical laboratory assessment (results ≥ 3 times the upper limit of normal \[ULN\] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin ≥ 2 times the ULN, or creatinine ≥ 1.5 times the ULN).
- Any new condition or worsening of existing condition which, in the opinion of the investigator, would put the subject at undue risk.
- Any serious adverse event or moderate/severe adverse event from the ORARIALS-01 trial which is ongoing at the time of transitioning to ORARIALS-02 and assessed as probably related to IMP
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03836716
Start Date
September 19 2019
End Date
July 2 2021
Last Update
August 24 2023
Active Locations (23)
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1
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Phoenix, Arizona, United States, 85013
2
UC Irvine Health ALS and Neuromuscular Center
Orange, California, United States, 92868
3
University of Miami
Miami, Florida, United States, 33136
4
Hospital for Special Surgery
New York, New York, United States, 10021