World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02714036
Date of registration: 09/03/2016
Prospective Registration: Yes
Primary sponsor: MediciNova
Public title: A Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)
Scientific title: A Multi-Center, Open-Label Biomarker Study to Evaluate MN-166 (Ibudilast) in Subjects With Amyotrophic Literal Sclerosis (ALS)
Date of first enrolment: May 6, 2016
Target sample size: 35
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02714036
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Contacts
Name:     Suma Babu, MBBS, MPH
Address: 
Telephone:
Email:
Affiliation:  Massachusetts General Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects must be diagnosed as having possible, probable, probable-laboratory
supported, or definite ALS, either sporadic or familial according to modified El
Escorial criteria.

2. Age 18 or above, able to provide informed consent, and safely comply with study
procedures.

3. Vital capacity (VC) of at least 50% predicted value for gender, height and age at
screening visit, or in the opinion of the study physician, able to safely tolerate
study procedures. (Not applicable to flexible arm)

4. Subject must be able to swallow oral medication at the Baseline Visit and expected to
be able to swallow the capsules throughout the course of the study.

5. Subject must not have taken 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). (Not applicable to flexible arm)

6. Women must not be able to become pregnant (e.g. post menopausal, surgically sterile,
or using adequate birth control) for the duration of the study and 3 months after
study completion.

7. Males should practice contraception for the duration of the study and 3 months after
completion.

8. Ability to safely lie flat for 90 min for PET procedures in the opinion of the study
physician. (Not applicable to flexible arm)

9. High or mixed affinity to bind TSPO protein (Ala/Ala or Ala/Thr) (see section 7.2.1).
(Not applicable to flexible arm)

10. Upper motor Neuron Burden (UMNB) Score =25 (out of 45) at screening visit. (Not
applicable to flexible arm)

Exclusion Criteria:

1. Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the
normal.

2. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of
normal.

3. The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the participant to provide informed consent, according to PI
judgment.

4. Clinically significant unstable medical condition (other than ALS) that would pose a
risk to the participant if they were to participate in the study.

5. History of HIV, clinically significant chronic hepatitis, or other active infection.

6. Active inflammatory condition of autoimmune disorder (Not applicable to flexible arm)

7. Females must not be lactating or pregnant.

8. Active participation in another ALS clinical trial or exposure to an off label ALS
experimental treatment within 30 days of the Baseline Visit (Not applicable to
flexible arm)

9. Exposure to immunomodulatory medications within 30 days of the Baseline Visit. (Not
applicable to flexible arm)

10. Any contraindication to undergo MRI studies such as

- History of a cardiac pacemaker or pacemaker wires

- Metallic particles in the body

- Vascular clips in the head

- Prosthetic heart valves

- Claustrophobia (Not applicable to flexible arm)

11. Radiation exposure that exceeds the site's current guidelines (Not applicable to
flexible arm)

12. EKG finding of QTc prolongation > 450 ms for males and > 470 ms for females at
screening or baseline.

13. Not on any prohibitive medication or known QT prolonging medication:



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Intervention(s)
Drug: ibudilast
Primary Outcome(s)
To measure the impact of MN-166 (ibudilast) on [11C]-PBR28 uptake in the motor cortices and brain stem measured by positron emission tomography (PET) imaging at 24 weeks [Time Frame: 24 weeks]
To measure the impact of MN-166 (ibudilast) on several markers of neuro-inflammation measured by blood biomarkers [Time Frame: 36 weeks]
Secondary Outcome(s)
To evaluate the safety and tolerability of MN-166 by assessing the number of treatment-related adverse events. [Time Frame: 36 weeks]
To evaluate the effect of ibudilast on strength as measured by Hand-held dynamometry (HHD) [Time Frame: 36 weeks]
To evaluate the effect of ibudilast on ALS functional rating scale-revised (ALSFRS-R) [Time Frame: 36 weeks]
To evaluate the effect of ibudilast on slow vital capacity (SVC) [Time Frame: 36 weeks]
Secondary ID(s)
MN-166-ALS-1202
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Massachusetts General Hospital
South Shore Neurologic Associates
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history