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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00616733 |
This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: CS-0777 tablets |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | An Open-Label, Escalating-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis |
Estimated Enrollment: | 18 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: CS-0777 tablets
0.1 mg, once-weekly, for 12 weeks
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2: Experimental |
Drug: CS-0777 tablets
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks
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3: Experimental |
Drug: CS-0777 tablets
0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon Herbert, PhD | S.Herbert@Medpace.com |
United States, Colorado | |
Recruiting | |
Denver, Colorado, United States | |
United States, Florida | |
Recruiting | |
Port Orange, Florida, United States | |
United States, Kansas | |
Recruiting | |
Lenexa, Kansas, United States | |
United States, Montana | |
Recruiting | |
Billings, Montana, United States | |
United States, Pennsylvania | |
Recruiting | |
Philadelphia, Pennsylvania, United States |
Responsible Party: | Daiichi Sankyo, Inc. ( James Moberly, PhD, Senior Director, Clinical Development ) |
Study ID Numbers: | CS0777-A-U102, IND 77,409 |
Study First Received: | February 4, 2008 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00616733 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Neoplasm Metastasis |
Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |