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Cognition DisordersPhase 2NCT00529581

A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis

A Phase 2 study testing C105 in people with Cognition Disorders and Multiple Sclerosis, run by Cognition Pharmaceuticals, LLC at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cognition Disorders, Multiple Sclerosis
What is being tested?
C105
How many people
150 participants
Where
30 sitesUnited States
Study dates
Nov 2006to Apr 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Neurology & Neuroscience Associates, Inc.

    Akron, Ohio, 44302

  • Shepard Center

    Atlanta, Georgia, 30309

  • The Jacobs Neurological Institute

    Buffalo, New York, 14203

  • Capitol Neurology

    Charleston, West Virginia, 25301

  • University of Virginia, Department of Neurology

    Charlottesville, Virginia, 22908

  • Riverhills Healthcare, Inc

    Cincinnati, Ohio, 45242

  • Associated Neurologists, P.C.

    Danbury, Connecticut, 06810

  • Henry Ford Health System, Department of Neurology

    Detroit, Michigan, 48202

  • Associated Neurologist of Southern Connecticut, PC

    Fairfield, Connecticut, 06824

  • MeritCare Neuroscience Clinic

    Fargo, North Dakota, 58103

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Kansas Medical Center, Department of Neurology

    Kansas City, Kansas, 66160

  • Research Center for Clinical Studies West

    Lancaster, California, 93534

  • MidAmerica Neuroscience Institute

    Lenexa, Kansas, 66214

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Loma Linda University, Department of Neurology

    Loma Linda, California, 92354

  • Neurology Associates, PA

    Maitland, Florida, 32751

  • Yale University MS Center

    New Haven, Connecticut, 06510

  • Saint Joseph's Hospital, Barrow Neurology Clinics

    Phoenix, Arizona, 85013

  • The Neurology Foundation, Inc.

    Providence, Rhode Island, 02905

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 17607

  • Neurological Associates, Inc

    Richmond, Virginia, 23230

  • Central Texas Neurology

    Round Rock, Texas, 78681

  • Integra Clinical Research

    San Antonio, Texas, 78229

  • Lovelace Scientific Resources

    Sarasota, Florida, 34233

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33701

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Northwest Neuro Specialists, PLLC

    Tuscon, Arizona, 85741

Other trials in United States

About this study

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

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.

Being tested
C105
Keywords
multiple sclerosis, cognitive impairment, cognitive dysfunction, Cognitive Dysfunction associated with Multiple Sclerosis
Medical subject headings
Cognition Disorders, Multiple Sclerosis, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C105Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct

    Measured: Change from baseline

  2. Subject's Global Assessment of Cognitive Change

    Measured: Change from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00529581
Sponsor's protocol ID
22029
Status last verified
May 2008
First submitted
12 Sep 2007
Last updated
28 May 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing C105 in people with Cognition Disorders and Multiple Sclerosis, run by Cognition Pharmaceuticals, LLC at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symbol Digit Modalities Test, Oral Version (SDMT) - Total # Correct (time frame: Change from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00529581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.

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