NL-OMON55065
Completed
Phase 3
Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial - Arimoclomol in patients with amyotrophic lateral sclerosis.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Orphazyme A/S
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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.
- •2\. 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
- •randomised treatment period).
- •3\. 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 Criteria
- •1\. Known or suspected allergy or intolerance to the IMP (arimoclomol or
- •constituents).
- •2\. Exposure to any other investigational treatment, advanced therapy medicinal
- •product (ATMP) or use of any other prohibited concomitant medications (see
- •section 6\.8\)
- •3\. 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary AngioedemaNL-OMON48865BioCryst Pharmaceuticals Inc.3
Completed
Phase 3
An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) That are Refractory to TreatmentLung infectionMycobacterial Lung lnfection1002844010024970NL-OMON43501lnsmed lncorporated1
Completed
Phase 3
An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia SyndromeFamilial Chylomicronemia Syndrome10013317NL-OMON41457ovartis9
Completed
Phase 4
An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care Settingsfactor VIII deficiencyHemophilia A1006447710005330NL-OMON39506Pfizer1
Completed
Phase 2
A randomized, open-label, parallel-group, multi-center study of adding edoxaban or clopidogrel to aspirin to maintain patency in subjects with peripheral arterial disease following femoropopliteal endovascular intervention-edoxaban in peripheral arterial disease (ePAD)narrowing of the peripheral arteries (mostly in the legs)periferal arterial disease10003216NL-OMON40071Daiichi Sankyo Development Ltd14