Status:
COMPLETED
RT001 in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Biojiva LLC
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
RT001-014 is a Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess Efficacy, Long Term Safety and Tolerability of RT001 in Subjects with Amyotrophic Lateral Sclerosis
Detailed Description
Forty subjects at 4 EU sites will undergo baseline examination, and then be randomized 1:1 to receive either RT001 or placebo. Repeat visits will occur every 2 months. The final visit will be at 6 mon...
Eligibility Criteria
Inclusion
- Male or female subject with age 20 years to 75 years at the time of signed consent
- Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
- ALSFRS-R \> 20
- Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life
- Patients of less than 3 years after the onset of ALS
- Subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend)
- If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation
Exclusion
- Received treatment with other experimental therapies within the last 30 days prior to the first dose
- Previously received treatment with RT001
- Refusal to discontinue fish oils or other oil-based supplements for the duration of the study (Screening till last study procedure completed)
- SVC \< 70 at screening
- Subject has a feeding tube or the need for a feeding tube is anticipated within the first 24 weeks after enrollment
- Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period
- Evidence of any clinically significant neurological disorder other than ALS
- The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria
- The subject has a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function
- Subject has had a significant illness or infection requiring medical intervention in the past 30 days
- Female who is breastfeeding or has a positive pregnancy test
- Male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled
- History, within the last 2 years, of alcohol abuse or physical opioid dependence
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04762589
Start Date
March 10 2021
End Date
June 28 2022
Last Update
July 1 2025
Active Locations (4)
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1
University of Tartu
Tartu, Estonia
2
Riga Stradins Universtiy
Riga, Latvia
3
UMC Utrecht
Utrecht, Netherlands
4
Karolinska
Stockholm, Sweden