1st Patient Enrolls in Phase 3 Trial of ADS-5102 as Way of Improving Walking Ability, Adamas Announces

1st Patient Enrolls in Phase 3 Trial of ADS-5102 as Way of Improving Walking Ability, Adamas Announces

A Phase 3 trial testing an oral once-a-day therapy — ADS-5102 (amantadine) extended release capsules — in multiple sclerosis (MS) patients with walking difficulties has enrolled its first participant, Adamas Pharmaceuticals announced.

The multi-center, double-blind study (NCT03436199) will assess ADS-5102 in about 570 such patients at five sites across the U.S. Eligible patients are being recruited at sites in Colorado, Georgia, New York, North Carolina and Washington.

Researchers will test the efficacy of  two doses,  274 mg or 137 mg, of ADS-5102 given at bedtime against each other and against a placebo. Effectiveness will be analyzed as a primary goal using the timed 25-foot walk (T25FW) test — a measure of mobility and leg function — at week 12. Changes in the Timed Up and Go (TUG) test — a measure of mobility — and in the 2-Minute Walk Test (2MWT) will also be assessed.

Amantadine extended release capsules, marketed by Adamas under the trade name Gocovri, were approved by the U.S. Food and Drug Administration  in August 2017 to treat the uncontrolled jerky movements that affect Parkinson’s patients on levodopa-based therapy.

“Initiating this Phase 3 study of ADS-5102 in MS patients with walking impairment is a significant milestone for Adamas, as it could potentially advance the approval of Gocovri (amantadine) extended release capsules as a treatment for this MS population,” Rajiv Patni, chief medical officer at Adamas, said in a press release.

It is set to conclude in September 2019; enrollment and other information is available by clicking here.

“The goal of the study is to confirm the results of our Phase 2 proof-of-concept study and to demonstrate the efficacy and safety of ADS-5102 using several measures of walking in MS patients,” Patni added.

The Phase 2 trial (NCT02471222) compared treatment with ADS-5102 against placebo in a total of 60 MS patients with walking impairments. ADS-5102 was given at a 137 mg dose in the first week and at 274 mg dose in subsequent weeks.

Results showed that ADS-5102 significantly improved T25FW scores in patients by 16.6 percent, and led to at least a 20 percent improvement in walking speed in a greater proportion of patients compared to placebo.

These data were reported in the study, “Safety and efficacy of ADS-5102 (amantadine) extended release capsules to improve walking in multiple sclerosis: A randomized, placebo-controlled, phase 2 trial, published in the Multiple Sclerosis Journal.

“Approximately half of MS patients become dependent on some form of walking aid after 15 years due to their underlying disease,” said Aaron Miller, MD, a member of trial’s steering committee.

Miller is also medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai, in New York.

“There is a significant unmet medical need for additional therapies to treat impaired mobility in MS as the current approved treatment option, for this critically important function, is demonstrated to not be effective for a majority of patients,” he concluded.

24 comments

  1. Nicole says:

    I have MS since 13 years and the only one difficulty I have is to walk because mes legs are spastic. I’m living to Quebec City in Canada and I say how long it will take before to be accepted by Healt Canada…
    I’m very interested to this medicament!!!

    • Sherry Smith says:

      I have too…100 mg 2 times a day. I been using it for several years and my legs have gotten weaker from the beginning. I am now using a walker. Very skeptical, but best of luck to participants!!

  2. Louise Paul says:

    I have been taking Amantadine for a number of years for fatigue & it does help walking a bit (very little) balance wise & heaviness. I have Neurologist appointment next week, going to ask about Fampridine for walking & stop amantadine,too many side effects Does anyone have experience with Fampridine to share?

  3. Debi says:

    I would be interested. I was diagnosed with ms in 2000 and haven’t been able to walk forin the last 3 years I’m only 46 I’m too young to rely on anybody. I need to be walking so I can enjoy my life and maybe go back to work.

  4. Donna says:

    Amantadine is available in a generic form, but somehow they will change one little thing and charge thousands of dollars for it. Just wait and see!

  5. Nancy Pigo says:

    How does this differ from Amprya? I am on this drug for walking. I still have trouble in the afternoon and cannot take another pill for at least 4 more hours.

  6. Linda Delay says:

    I have taken drugs for fatigue but the after effects are disturbing. I don’t know the age limit. I still walk and talk ok. Fatigue is a big issue.

  7. Sally says:

    I would like to know how this drug is different than Ampyra. Been on Ampyra for years and I don’t like the potential side affects.

  8. Cathy Schroll says:

    I take amantadine 100mg caps. twice a day. I take this for fatigue. Not sure what it does for walking. Please advise.

  9. Nikki says:

    I take 4aminopyridine 2 times a day. I haven’t really noticed any difference. It does seem to make me overheat, though. Living in New Orleans is already hot enough. I’d be interested if this actually works.

  10. Vickie Hartman says:

    I have Ms and i can’t walk only with a walker would love to know if this would work on me. I’m in W.VA

  11. Sabina M says:

    I have MS for 21 years. Was at first diagnosed with Relapsing/Remitting. Was on Avonex for 10 years. After that, everything you can name, copaxone,Rebif,etc. Then came Tysabri-it was a god-send!I was wearing 6 inch heels to work, could go dancing, was an avid runner and went to the gym three tines a week. Then I tested positive for the JC virus-no more Tysabri for me. I was changed to Lemtrada (which honestly did not work) and at that time my diagnosis changed to SPMS. No more heels for me! and I had to go on disability. My walking is getting steadily worse. Since I cannot take Ampyra, I am looking forward to go on Amantadine…

    • James says:

      Try Ocrelizumab, I was on tysabri, same thing for about 14 years, then boom, JC positive
      Changed to Ocrelizuma, and it’s like nothing changed, just don’t have to go to hospital every month.

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