Developing appropriate treatments for neurological disorders is one of today’s major global public health challenges. From chronic neuropathic pain to neurodegenerative diseases, neurological conditions vary significantly in terms of etiology, treatments, and socio-economic implications.
At ethica CRO, we understand the unique challenges and intricacies involved in neurological drug research and, over the years, we have honed our expertise in a number of neurological therapeutic areas. Our prior neurological experience lies within—but is not limited to—the following conditions:
Chronic and episodic migraine
12% of the world's population - including children - suffers from migraine.
Chronic pain syndromes
Chronic pain affects over 31 million people in North America.
Over 2.4 million adults experience some form of limb spasticity in the United States.
Do you want to learn more about how our clinical expertise can benefit your neurology study?
Our Neurology Clinical Trial Experience
Our study management team is prepared to help you efficiently conduct your neurological clinical trials, and we are always committed to mitigating risks and reducing study-related costs.
Since its inception, ethica CRO has completed over 40 neurological studies. The graphic below describes the percentage of studies per indication undertaken by our study management team to this day:
Your CRO of Choice for Neurology Clinical Research
Our team will help you:
- Develop study protocols alongside key opinion leaders (KOLs);
- Propose methodologies focused on reducing variability and bias, especially when dealing with participant reported outcomes measures;
- Promote compliance and retention, especially when dealing with populations suffering from neurodegenerative diseases.
Case Study – How ethica CRO built a rigorous post-marketing exploratory research program that led to the FDA approval of BoNT-A for a number of neurological indications
Our team at ethica CRO conducted a series of studies within the post-marketing research program of a reputable US-based pharmaceuticals company. The clinical objective of these trials was to assess the efficacy of botulinum neurotoxin type A (BoNT-A) for a number of neurological conditions, including cervical dystonia, limb spasticity, chronic migraine, hyperhidrosis, temporomandibular joint disorder, and overactive bladder.
We performed a full range of clinical and data management related activities for over 30 studies, from study start-up to closeout. Importantly, we developed the study protocols alongside key opinion leaders to ensure proper study design and statistical methodology.
In order to effectively manage this program, we assembled a full-capacity clinical management team within ethica CRO, dedicated to overseeing all BoNT-A trial activities. This group consisted of a project management panel, clinical trial associates, biostatisticians, and data management personnel—all of whom demonstrated a great deal of flexibility in response to the complex technical requirements of this research program.
ethica CRO proceeded to successfully conduct the post-marketing research program for BoNT-A. This led to numerous scientific publications and presentations at major symposia, as well as the Food and Drug Administration’s (FDA) approval of BoNT-A for a number of neurological indications including chronic migraine, hyperhidrosis, cervical dystonia, adult and pediatric upper and lower limb spasticity, facial movement disorders, overactive bladder, and urinary incontinence.