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Quick Info
Status
This study has been completed
Phase
2
Trial Type
Double Blind Placebo Controlled
Treatment Type
Tablet by mouth
Randomization
Unknown
Enrollment
71
Start Date
9/1/2014
Sponsor
Locations
United States, North Carolina
Carolinas Healthcare System, Dept. of Neurology, Charlotte, NC, 28232-2861, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>60
Months Since Onset
Number of months since first symptoms of ALS.
<60
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Yes
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
No
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Open Label
Unknown
Update Notes
No significant updates
5/12/2020
No significant updates.
11/28/2018
Trial complete
2/5/2018
No significant updates.
10/23/2017
No significant updates.
8/17/2017
Recruitment status updated
9/20/2016
No significant updates.
3/17/2016
Enrollment criteria updated.
9/28/2015
Protocol updated.
3/4/2015
Enrollment criteria updated.
9/26/2014
Clinical trial added.
9/15/2014

Other Information

Purpose
This is a single center, randomized, double-blind, placebo-controlled, 6-month study designed to evaluate the safety, tolerability and clinical responsiveness of MN-166/ibudilast (60 mg/day) when administered as an adjunct to riluzole (100 mg/day) in 60 subjects with ALS. This study will consist of two treatment arms, MN-166 and matching placebo. Randomization will occur in a 2:1 ratio (MN- 166: placebo). Duration of Treatment: Screening Phase: up to 3 months; Double-blind Phase: 6 months; Open-label Phase 6 months (for placebo subjects only); Follow-up Phase: 2 weeks after last dose. During treatment phase, subjects return to the clinic at Months 3 and 6 and will be telephoned by staff at Months 1,2,4, and 5 to collect information about side effects and new or concomitant medications. All subjects (subjects who complete the Double-blind Phase and subjects who complete the Open-label Phase) or prematurely discontinue will return for a follow-up visit approximately 2 weeks after the last dose of study drug to assess adverse event status and to document concomitant medications. Safety will be assessed by monitoring and recording all treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs) and discontinuations due to TEAEs. Additional assessments will include regular monitoring of hematology, blood chemistry, and urine values, regular measurement of vital signs, ECGs, medical history, physical and neurological examinations.
Eligibility
18 Years and Older; all Genders; No Healthy Volunteers. Ability to swallow.
Details
Inclusion Criteria: -Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug. Subjects not currently taking riluzole will be started on 50 mg qd for the first 7 days followed by 50 mg bid for the following 21 days prior to screening. Patients may be screened during this time period but not started on study drug until they are on a stable dose of riluzole. -All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Females of childbearing potential must use an effective method of contraception throughout the entire study period and for 30 days after study drug discontinuation. -Able to swallow study medication capsules. -Has received 23-valent pneumococcal vaccine within 4 years prior to starting clinical trial. Exclusion Criteria: -Use of tracheostomy, tracheostomy invasive mechanical ventilation [TIMV]. -Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator. -Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, or central nervous system infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
Collaborator(s)
Trial Protocol as Published on Clinicaltrials.gov
NCT02238626 (First Published: 9/4/2014)