NeuroDerm Achieves Primary Endpoint in ND0612H Phase II Trial for Advanced Parkinson’s Disease

NeuroDerm (Nasdaq:NDRM) reported that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints.

As quoted in the press release:

Trial 006 Endpoints
The primary endpoint of this study was to assess the change from baseline to day 28 in daily OFF-time (normalized to 16 waking hours) as assessed by a blinded rater.  A key secondary endpoint was to assess the percentage of subjects who were “ON” by 8:00am and 9:00am. Additional secondary endpoints were also evaluated as well as safety and tolerability.

Trial 006 Design
Trial 006 was a 28-day multicenter, international (US, EU and Israel), parallel-group, blinded rater, randomized phase II study that investigated the efficacy, safety, tolerability and pharmacokinetics of two dosing regimens (R1 and R2) of ND0612H and compared them to the baseline of standard optimized oral therapy:

• R1: 24 hour administration of ND0612H (720/90mg LD/CD) at a high day rate for 18 hours and a low night rate for 6 hours.
• R2: 14 hour administration of ND0612H during the waking hours (538/68mg LD/CD) complemented by a morning dose of 150/15mg oral LD/CD.

All patients could add oral LD/CD therapy at any time as needed.  The trial enrolled 38 patients with advanced Parkinson’s disease.

Trial 006 Preliminary Results
The 38 enrolled subjects had typical characteristics for patients with advanced Parkinson’s disease including: an average age of 63.5 years, 11.5 years since diagnosis and an average baseline OFF-time of 5.3 hours per day.

Click here for the full press release.