The Role of Clinical Trials in MS Research

Clinical trials are research studies conducted to evaluate the safety, efficacy, and potential side effects of new treatments or interventions. They play a critical role in identifying better therapies for MS by exploring:

Disease-Modifying Therapies (DMTs):

These aim to reduce the frequency and severity of relapses and slow the progression of disability.

Symptom Management:

Clinical trials often focus on interventions to alleviate symptoms like spasticity, pain, and fatigue.

Rehabilitation and Lifestyle Interventions:

Trials may evaluate the impact of physical therapy, diet, and exercise on MS progression and symptom control.

Biomarkers and Diagnostics:

Studies seek to improve diagnostic tools and identify biomarkers for tracking disease progression and treatment response.

Phases of MS Clinical Trials

Clinical trials typically progress through several phases:

Preclinical Phase:

Before testing in humans, researchers conduct laboratory and animal studies to gather preliminary data on safety and efficacy.

Phase 1:

Focuses on evaluating the safety of a treatment in a small group of healthy volunteers or patients.

Phase 2:

Explores the efficacy of the treatment and continues monitoring for side effects in a larger group of participants.

Phase 3:

Compares the new treatment to existing standard therapies, involving hundreds or thousands of participants across multiple locations.

Phase 4 (Post-Marketing Studies):

Conducted after a treatment is approved, these trials monitor long-term safety and effectiveness.

Recent Advancements in MS Clinical Trials

B-cell Therapies:

Treatments like ocrelizumab have demonstrated significant efficacy in reducing disease activity in both relapsing and primary progressive MS.

Remyelination Therapies:

Trials focusing on agents like clemastine fumarate aim to repair damaged myelin, offering hope for reversing disability.

Stem Cell Therapy:

Autologous Hematopoietic Stem Cell Transplantation (AHSCT) has shown promise in halting disease progression in some patients.

Digital Health Tools:

Trials are increasingly incorporating wearable devices and mobile apps to monitor symptoms and activity levels in real-time.

How to Participate in an MS Clinical Trial

Participating in a clinical trial provides patients with access to cutting-edge therapies while contributing to scientific knowledge. To find a suitable trial:

Consult with your Neurologist: They can help identify trials that match your condition and treatment goals.

Explore Online Databases: Websites like ClinicalTrials.gov provide comprehensive listings of ongoing trials.

Contact MS Research Centers: Many MS centers have dedicated teams coordinating clinical trial participation.

Companies are actively conducting clinical trials to develop new treatments for multiple sclerosis (MS):

Sanofi: Sanofi's experimental drug tolebrutinib has shown promise in delaying the progression of certain forms of MS. In a recent late-stage trial, tolebrutinib demonstrated a 31% delay in disease progression for a severe form of MS. Sanofi plans to seek regulatory approval for tolebrutinib later this year, aiming to strengthen its MS treatment portfolio following the loss of patent protection for its previous MS medication, Aubagio.

Synaptogenix: Synaptogenix has received FDA authorization to conduct clinical trials for Bryostatin-1, an investigational treatment for MS. This approval allows the company to evaluate the efficacy and safety of Bryostatin-1 in patients with MS.

Denali Therapeutics and Sanofi Collaboration: Denali Therapeutics, in collaboration with Sanofi, has been developing oditrasertib, an experimental drug targeting MS. However, a mid-stage clinical study for oditrasertib was recently terminated after the drug failed to achieve its primary and secondary endpoints. This follows a previous setback where oditrasertib did not meet primary goals in a study for amyotrophic lateral sclerosis (ALS).

Compensation - How much could you get paid?

Compensation for participating in macular degeneration clinical trials varies based on factors such as the trial's phase, duration, procedures involved, and location. Generally, clinical trial participants can receive compensation ranging from a few hundred to several thousand dollars. For instance, Phase 1 trials, which often involve healthy volunteers and assess the safety of a new treatment, tend to offer higher compensation, with median payments around $3,070, ranging from $150 to $13,000. Later-phase trials, such as Phase 2 or 3, may offer less compensation but still often pay hundreds or up to a few thousand dollars per participant.