View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
  2. Company News
August 31, 2018updated 12 Jul 2022 1:12pm

MediciNova reports positive results from SPRINT-MS trial

MediciNova has reported positive results from the SPRINT-MS Phase llb trial that examined the safety, tolerability of MN-166 (ibudilast) for the treatment of progressive multiple sclerosis (progressive MS).

MediciNova has reported positive results from the SPRINT-MS Phase llb trial that examined the safety, tolerability of MN-166 (ibudilast) for the treatment of progressive multiple sclerosis (progressive MS).

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The trial enrolled 255 patients with primary progressive or secondary progressive multiple sclerosis (PPMS and SPMS) at 28 clinical sites across the US.

The PPMS patients were either untreated with long-term disease-modifying therapy (DMT) or being treated with either glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b).

As part of the trial, the patients were randomly distributed in 1:1 ratio to administer a twice-daily oral dose of MN-166 (ibudilast) up to 100mg/day or inactive control (placebo).

The SPRINT-MS’ primary objectives were to analyse the activity of ibudilast (MN-166) against placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF).

“Our hope is that the benefit of ibudilast in slowing brain shrinkage will also translate to decreased progression of associated physical disabilities in a future Phase lll trial.”

The trial also examined the safety and tolerability of ibudilast (MN-166) in comparison with placebo in the enrolled subjects.

The trial’s additional measures comprise disability, imaging analyses of brain and retinal tissue integrity, as well as cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain.

Its exploratory objectives were pharmacokinetic and biomarker analyses.

Results from the trial showed that ibudilast was better than placebo in reducing brain shrinkage.

They also showed that the most common side effects of ibudilast were gastrointestinal, including nausea and diarrhea, in addition to headaches and depression.

SPRINT-MS trial principal investigator Robert Fox said: “These findings are significant for patients with progressive MS.

“Our hope is that the benefit of ibudilast in slowing brain shrinkage will also translate to decreased progression of associated physical disabilities in a future Phase lll trial.”

The SPRINT-MS trial received a portion of its funding from the US National Institutes of Health (NIH) and support from NeuroNEXT, Cleveland Clinic and others.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena