Phase 3 Trial Enrollment Underway for Parkinson’s Disease Motor Movement Therapy

Phase 3 Trial Enrollment Underway for Parkinson’s Disease Motor Movement Therapy

NeuroDerm has started enrolling Parkinson’s disease (PD) patients in iNDiGO, a Phase 3 clinical trial evaluating the effectiveness of ND0612L, the company’s levodopa/carbidopa (LD/CD) subcutaneous liquid formulation.

Levodopa and dopamine agonists, the first line of defense against Parkinson’s disease, are drugs commonly used to improve and control the symptoms of tremor, muscular rigidity, and slow, imprecise movement.

Over time, however, Parkinson’s patients start to develop motor fluctuations, the result of variations in patients’ response to levodopa. Motor fluctuations oscillate between “off” times, a state of decreased mobility, and “on” times, or periods when the medication is working and symptoms are controlled.

ND0612L is being developed to treat moderate stage Parkinson’s patients who can no longer effectively control their motor complications with oral levodopa. ND0612L can be continuously administered as a fixed dose over 24 hours. ND0612L maintains steady plasma levodopa concentrations, which should improve Parkinson’s patients’ motor and non-motor complications, including dyskinesia and “off” periods.

iNDiGO (NCT02782481) is a 16-week multicenter, randomized, double-blind, placebo-controlled clinical trial that will compare the effectiveness, safety and tolerability of ND0612L combined with oral standard of care or a placebo in Parkinson’s patients who have motor fluctuations despite optimized standard-of-care therapy.

Patients will be randomly assigned either to ND0612L or a placebo that will be replaced every 24 hours. The primary endpoint of iNDiGO is the change from baseline to week 16 in the mean percentage of “OFF” time based on patients’ home diary assessments.

The original trial design anticipated enrolling 200-240 patients, but NeuroDerm reduced this number to 150 patients after sample size calculations using the expected treatment effect and variability as well as those observed in a previous Phase 2 clinical trial.

In that Phase 2 trial, patients with moderate to severe Parkinson’s disease who received adjunct ND0612L therapy exhibited clinically significant reduction in fluctuations of plasma levodopa concentrations compared to patients receiving a placebo. Patients receiving ND0612L also experienced a corresponding in-clinic two-hour reduction over placebo in “off” time, improved sleep, better quality of life and global clinical improvement without an increase in troublesome dyskinesia.

The iNDiGO trial is expected to end in 2017.

“The initiation of the iNDiGO trial marks another important milestone in the development of ND0612L as part of our Parkinson’s disease treatment pipeline,” NeuroDerm CEO Oded S. Lieberman, PhD, said in a press release. “The current reduction in the number of patients to be enrolled in our iNDiGO trial, following streamlining this past November of our clinical development program from two Phase 3 trials to one trial, should further simplify and facilitate our clinical development program for ND0612L.”

“We believe that ND0612L holds tremendous potential in providing PD patients with a simple, continuous levodopa delivery treatment option that does not require surgery. ND0612L is further being developed for future delivery through a small patch pump that should offer a new level of therapy convenience. We are committed to making this promising candidate available to patients as quickly as possible and are pleased to have this trial underway,” Lieberman said.

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Daniela holds a PhD in Clinical Psychology from The University of Edinburgh, United Kingdom, a MSc in Health Psychology and a BSc in Clinical Psychology. Her work has been focused on vulnerability to psychopathology and early identification and intervention in psychosis.

2 comments

  1. Joseph Glick says:

    I have had PD for four years. I am way over the maximum dosage of Carbidopa Levadopa, taking 2 1/2 tablets 6x per
    Day. I take Comtan with the first five doses of Carbidopa Levadopa and also take Azilect, Amantadine 2x/ day and Mirapex ER. I also take a 25/100 ER 2x/day and a 50/200 at bedtime. I still experience motor fluctuations and tremors late in the day and at night. I would like to be in the phase 3 Indigo trial. Please advise

  2. Rita Cosman says:

    I have Parkinson , my problem is freezing up a lot. I can’t seem to make myself go ,I do not have the tremors, but I lost my writing . can’t even print anymore, my voice is very low. My balance is crazy . I fall a lot. I take Pramipexoe 9 tablets per day. I also take Levocarb 8 per day. I just wish there was a tablet that would help me with my freezing .I could handle the rest of my problems. I never stopped doing things until i got Parkinson.

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