Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02471222
• Date of registration: 11/06/2015
• Prospective Registration: No
• Primary sponsor: Adamas Pharmaceuticals, Inc.
• Public title: Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
• Scientific title: Safety and Efficacy of ADS-5102 (Amantadine HCl) Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
• Date of first enrolment: May 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02471222
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Walking Impairment

Multiple Sclerosis

Intervention(s)

Drug: ADS-5102

Other: Placebo

Primary Outcome(s)

Safety of ADS-5102 assessed by adverse events, safety-related study drug discontinuations, vital signs, and safety laboratory test [Time Frame: Up to 4 weeks]

Secondary Outcome(s)

2 Minute Walk Test [Time Frame: Up to 4 weeks]

Timed Up and go [Time Frame: Up to 4 weeks]

Timed 25 Foot Walk [Time Frame: Up to 4 weeks]

MS Walking Scale-12 [Time Frame: Up to 4 weeks]

Secondary ID(s)

ADS-AMT-MS201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors