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A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis
This study has been completed.

First Received on September 12, 2007.   Last Updated on May 23, 2008   History of Changes
Sponsor: Cognition Pharmaceuticals, LLC
Information provided by: Cognition Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00529581
  Purpose

The purpose of this study is to determine the safety and efficacy of C105 in treating the cognitive deficits that can occur due to multiple sclerosis.


Condition Intervention Phase
Cognition Disorders
Multiple Sclerosis
Drug: C105
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of C105 in Persons With Multiple Sclerosis With Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Cognition Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct [ Time Frame: Change from baseline ]
  • Subject's Global Assessment of Cognitive Change [ Time Frame: Change from baseline ]

Estimated Enrollment: 150
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males/females at least 18 years old and < 65 years old, capable of understanding and complying with the protocol, including speaking and writing fluent English and having at least a 9th grade education
  • Clinically definite diagnosis per McDonald criteria of Multiple Sclerosis as confirmed by the Investigator (Relapsing-Remitting or Secondary Progressive)
  • Stable disease and relapse-free for > 90 days as verified by Investigator
  • Presence of cognitive deficit as measured score of -1.5 SD on the SDMT (oral version) or a score of -1.0 SD on the SDMT and -1.0 SD on either CVLT-II (total learning or delayed recall) or PASAT
  • EDSS <= 6.5
  • Standard score of >79 on the WRAT-4 Reading test
  • Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
  • Capable of performing the requirements of a neuropsychological test battery including having at least 20/70 near visual acuity by near vision chart, with correction (i.e., eyeglasses) allowed
  • If female, must neither be pregnant nor breast-feeding and she must either (a) be > 12 months post-menopausal or surgically sterilized or (b) must agree to use an acceptable method of birth control (including hormonal contraceptives, intra-uterine device, or barrier methods such as condoms, diaphragm, etc. with spermicide) for the duration of the study. Abstinence will not be considered an acceptable method of birth control.

Exclusion Criteria:

  • Subjects with memory deficits caused by concomitant medication usage or other significant neurological/psychological disease, e.g., Alzheimer's disease, Parkinson's disease, stroke, TIA, Multi-infarct dementia, Huntington's disease, head trauma, or chronic CNS infection
  • Evidence of other medical cause of dementia
  • Evidence of Major Depressive Disorder as determined by a Beck Fast Screen core of >3 and clinician interview
  • Use of the following medications: Antipsychotic agents, Centrally acting appetite suppression drugs (e.g., sibutramine), CNS stimulants or drugs that metabolize to them (e.g., amantadine, Concerta, methylphenidate, Adderall, ephedrine, selegiline), Strattera (atomoxetine), Tricyclic antidepressants (e.g., amitriptyline), Herbal preparations including Ginkgo Biloba or containing Ephedra or other stimulants, MAO inhibitors. Note: other medications may be excluded or permitted, depending on length of treatment and stability of dose
  • Uncontrolled or labile hypertension, or any clinically significant, unstable, or major concomitant disorder as determined by the Principal Investigator
  • Active malignancy within one year of study participation
  • Known human immunodeficiency virus (HIV)
  • Current diagnosis of unstable glaucoma
  • History of myocardial infarction of symptomatic Coronary Artery Disease
  • Evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ECG
  • History of epilepsy or other seizure disorders
  • Clinically significant motor or speech residual neurological deficits (e.g., hemiparesis, aphasia) that interfere with completion of study procedures
  • Baseline clinical laboratory values indicative of a clinically significant co-morbidity
  • Significant recent history of (within past 12 months) or current drug or alcohol abuse (as defined by DSM-IV)
  • Known allergy or hypersensitivity to amphetamines or other sympathomimetic amines
  • Participation in any clinical trial with an investigational drug within 30 days prior to randomization
  • In the opinion of the Principal Investigator should not participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529581

  Show 30 Study Locations
Sponsors and Collaborators
Cognition Pharmaceuticals, LLC
Investigators
Principal Investigator: Frederick Munschauer, MD SUNY Buffalo
Principal Investigator: Ralph Benedict, PhD SUNY Buffalo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00529581     History of Changes
Other Study ID Numbers: 22029
Study First Received: September 12, 2007
Last Updated: May 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cognition Pharmaceuticals, LLC:
multiple sclerosis
cognitive impairment
cognitive dysfunction
Cognitive Dysfunction associated with Multiple Sclerosis

Additional relevant MeSH terms:
Cognition Disorders
Multiple Sclerosis
Sclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012