Clinical Trials

Colorado Springs Neurological Associates is one of the largest and longest-standing neuroscience medical practices in southern Colorado.  Our aim is to deliver the highest standard of neurological care – the same level of care we would want for ourselves or our loved ones.  The Center has a dedicated clinical research institute with experienced principal investigators and a full-time research staff.  Collectively, our investigators have vast experience conducting phase II through phase IV clinical trials in a broad range of neurologic diseases affecting adults and children.


 

Multiple Sclerosis Research:

1.    Title: Acthar Gel: A prospective observational registry of H.P Acthar Gel for the treatment of Multiple Sclerosis relapse.
Sponsor: Mallinckrodt
Principle Investigator: Christen Kutz, PhD, PA-C

2.    Title: Asclepios: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Comparing the Efficacy and Safety of ofatumumab administered subcutaneously versus teriflunomide administered orally in patients with relapsing forms of Multiple Sclerosis.
Sponsor: Novartis
Principle Investigator: Kimberly Wagner, MD

3.    Title: PASS: A Prospective, Multicenter, Observational Post-Authorization Safety Study to Evaluate the Long Term Safety Profile of Lemtrada Treatment in Patients with Relapsing Forms of Multiple Sclerosis.
Sponsor: Genzyme
Principle Investigator: Laurence Adams, MD

4.    Title: Elevate MS:  Evaluation of Evidence from Smart Phone Sensors and Patient-Reported Outcomes in People with Multiple Sclerosis.
Sponsor: Novartis
Principle Investigator: Christen Kutz, PhD, PA-C

5.    Title: Fluent: A 12 month, prospective, multi-center, two-cohort, non- randomized, open-label study in adult patients with relapsing Multiple Sclerosis to investigate changes in immune phenotype biomarkers after treatment with 0.5mg of Gilenya (fingolimod).
Sponsor: Novartis
Principle Investigator: Kimberly Wagner, MD

6.    Title: Passage: Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on Gilenya (fingolimod) once daily.
Sponsor: Novartis
Principal Investigator: Aparna Komatineni, MD

7.    Title: ESTEEM: A multi-center, global, observational study to collect information on safety and to document the drug utilization of Tecfidera when used in routine medical practice in the treatment of Multiple Sclerosis.
Sponsor: Biogen
Principle Investigator: Christen Kutz, PhD, PA-C

8.    Title: POP: Plegridy real-world effectiveness and safety observation program.
Sponsor: Biogen
Principle Investigator: Aparna Komatineni, MD

ALS Research:

9.    Pennant Study:  A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis.
Sponsor: Mallinckrodt  
Principle Investigator: Julia Brinley, DO

Huntington’s disease Research:

10.    Enroll HD:  A Prospective Registry Study in a Global Huntington's Disease Cohort A CHDI Foundation Project.  
Sponsor: CHDI
Principal Investigator: Christen Kutz, PhD, PA-C

Epilepsy Research:

11.    Title: A Phase III Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Vimpat (lacosamide) as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy (SP0982 Study) and in the long term follow-up Study (EP0012).
Sponsor: UCB
Principle Investigator: Kimberly Wagner, MD

Parkinson’s disease Research:

12.    Title: Effects of Northera (droxidopa) when measuring gait speed, kyphosis, and functional reach in Parkinson’s disease.
Sponsor: Lundbeck grant
Principle Investigator: Laurence Adams, MD

Orthostatic Hypotension Research:

13.    Title: Restore: Phase 4 Clinical Study of Northera “droxidopa” in Patients with Symptomatic Neurogenic Orthostatic Hypotension.
Sponsor: Lundbeck
Principle Investigator: Laurence Adams, MD

Pediatric Migraine Research:

14.    Title: A Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of Onzetra Xsail (sumatriptan nasal powder) for the acute treatment of episodic migraine with or without aura in adolescents.
Sponsor: Avanir
Principal Investigator: Kimberly Wagner, MD

Alzheimer’s disease Research:

15.    Title: Generations 1: A randomized, double blind, pacebo-controlled, two cohort parallel group to evaluate the efficacy of CAD106 (injection) and CNP520 (oral) in participants at risk for the onset of clinical symptoms of Alzheimer’s disease.
Sponsor: Novartis
Principal Investigator: Kimberly Wagner, MD

16.    Title: Generations 2: A randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer’s disease.
Sponsor: Novartis
Principal Investigator: Kimberly Wagner, MD

Neurosurgical Research:

17.    Title: Ravine: A comparison of complication rates between lateral approaches to the lumbar spine: K2M Ravine Far Lateral System vs. NuVasive XLIF
Sponsor: K2M
Principal Investigator: Sana Bhatti, MD

Research Staff