Clinical trial NCT02471222 (phase 2, status: completed)
Conditions: walking impairment, multiple sclerosis
ICD codes: G35, C81.18
Drugs: ads-5102
SMILES: NC12CC3CC(CC(C3)C1)C2
Eligibility criteria:

        Inclusion Criteria:

          -  Signed a current IRB-approved informed consent form;

          -  Male or female subjects between 18 and 70 years of age, inclusive;

          -  Confirmed diagnosis of Multiple Sclerosis according to the 2010 Revised McDonald
             criteria;

          -  On a stable regimen of medications taken specifically to treat MS for at least 30 days
             prior to screening, and willing to continue the same doses and regimens for the
             duration of study participation;

          -  Stable physical activity level for at least 30 days prior to screening and willing to
             continue without change for the duration of study participation;

          -  Maximum EDSS score during screening of 6.5;

          -  Sufficient ambulatory ability to complete two trials of the Timed 25 Foot Walk (T25FW)
             at the screening visit;

          -  A score on each completed screening T25FW test between 8 and 45 seconds, inclusive;

          -  Any other current and allowed prescription/non-prescription medications and/or
             nutritional supplements taken regularly must have been at a stable dose and regimen
             for at least 30 days prior to screening, and subject must be willing to continue the
             same doses and regimens during study participation;

          -  If taking an antidepressant, must be on a stable dose for at least 60 days prior to
             screening.

        Exclusion Criteria:

          -  History of seizures within 2 years prior to screening;

          -  Clinically significant MS relapse with onset less than 30 days prior to screening;

          -  Presence of vertigo or other vestibular dysfunction that might compromise ability to
             safely perform the T25FW;

          -  Received physical therapy within 30 days prior to screening;

          -  Received systemic steroids within 30 days prior to screening;

          -  Received dalfampridine, methylphenidate, modafinil, armodafinil, amantadine, and/or
             any product containing amphetamines, or any treatment specifically for fatigue or to
             improve walking within 30 days prior to screening;

          -  Received any botulinum toxin containing product used as antispasmodic agent within 3
             months prior to screening;

          -  History of clinically significant hallucinations due to an MS medication or
             other/unknown cause, within 2 years prior to screening;

          -  History of Bipolar Disorder or Psychosis, regardless of treatment;

          -  Presence of cognitive impairment sufficient, in the opinion of the investigator, to
             affect the subject's ability to complete study assessments, or which would not be in
             the subject's best interest to participate in the study;

          -  History of stroke or TIA within 2 years prior to screening;

          -  History of cancer within 5 years;

          -  Presence of untreated angle closure glaucoma;

          -  If female, is pregnant or lactating;

          -  If a sexually active female, is not surgically sterile or at least 2 years
             post-menopausal, or does not agree to utilize a highly effective hormonal method of
             contraception (an IUD, or vasectomized male partner is also acceptable), in
             combination with a barrier method, from screening through at least 4 weeks after the
             completion of study treatment;

          -  Treatment with an investigational drug or device within 30 days prior to screening;

          -  Treatment with an investigational biologic within 6 months prior to screening;

          -  Current participation in another clinical trial;

          -  Planned elective surgery during study participation.