Trial for MS patients with Cognitive Impairment

Trial Information

Summary: A Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Efficacy and Tolerability of C105 in Persons with Multiple Sclerosis with Cognitive Impairment

This is a Phase II research study for people with Multiple Sclerosis with cognitive impairment. Enrollment is expected to last through August 2007 and will include about 150 subjects across the US at 25 sites. The study drug is being tested for safety and to evaluate its benefits on such functions as memory and thinking skills. Eligible subjects will be required to visit the study clinic approximately 6 times over a 3 month period. There are numerous neuropsychological tests conducted at most of the study visits which may last up to 6 hours.

Eligibility:

• Study is open to men and women 18-64 years old who have at least a 9th grade education
• Diagnosis of MS (Relapsing Remitting or Secondary Progressive)
• Have sufficient cognitive impairment to meet the criteria

Subjects will not be able to participate if they:

• Have memory deficits caused by significant neurological/psychological disorders
• Have a Major Depressive Disorder
• Are taking certain medications, including tricyclic antidepressants, antipsychotics, Strattera, CNS stimulants
• Have uncontrolled hypertension, epilepsy or coronary artery disease

Additional criteria for participation will be discussed with eligible participants.