Trial record 1 of 5 for:
neuralstem
Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects
This study is currently recruiting participants.
Verified November 2012 by Neuralstem Inc.
Sponsor:
Neuralstem Inc.
Information provided by (Responsible Party):
Neuralstem Inc.
ClinicalTrials.gov Identifier:
NCT01520649
First received: January 25, 2012
Last updated: January 17, 2013
Last verified: November 2012
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Purpose
This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed human subjects study.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: NSI-189 Phosphate Drug: microcrystalline cellulose capsules |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Cellulose, microcrystalline
U.S. FDA Resources
Further study details as provided by Neuralstem Inc.:
Primary Outcome Measures:
- Safety of drug assessed by number and severity of adverse events in drug vs placebo group [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Values for vital signs, standard physical examination, ECG, EEG, standard clinical laboratory tests (hematology and biochemistry), standard neurological exam and the Columbia Suicide Severity Rating Scale will be compared between NSI 189 and placebo.
Secondary Outcome Measures:
- Pharmacokinetics of NSI 189 will be determined by plasma sample collection at various timepoints pre, during and post dosing, measuring the concentration of drug over time. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Concentration of NSI 189 will be measured in plasma and standard pK values will be determined:AUC, Cmax, Tmax, T1/2, CL, Vz.
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NSI-189 Phosphate
There will be 3 ascending cohorts. The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
|
Drug: NSI-189 Phosphate
The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
|
|
Placebo Comparator: microcrystalline cellulose capsules
The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
|
Drug: microcrystalline cellulose capsules
The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent, authorizing to use of protected health information in accordance with national and local patient privacy regulations.
- Males and females 18 to 60 years of age, inclusive, at the time of informed consent.
Diagnosis of major depressive disorder, recurrent, as per DSM-IV-TR criteria and confirmed by SCID-CT. Their major depressive episode must be confirmed via SCID mood module interview administered by remote, independent raters.
Note: Both patients who are being treated with antidepressants and patients who are not on antidepressants but had a history of taking antidepressants are permitted in the study.
- Montgomery-Asberg Depression Scale (MADRS) score of 15 to 30, inclusive, at Screening and baseline.
- The following applies to female patients:Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the end-of-study.
- The following applies to male subjects:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520649
Contacts
| Contact: Lev G. Gertsik, MD | 888-228-7425 |
Locations
| United States, California | |
| California Clinical Trials | Recruiting |
| Glendale, California, United States | |
| Contact 888-228-7425 | |
| Principal Investigator: Lev G Gertsik, MD | |
Sponsors and Collaborators
Neuralstem Inc.
Investigators
| Study Director: | Karl Johe, PhD | Neuralstem Inc. |
More Information
No publications provided
| Responsible Party: | Neuralstem Inc. |
| ClinicalTrials.gov Identifier: | NCT01520649 History of Changes |
| Other Study ID Numbers: | NS-2010-3 |
| Study First Received: | January 25, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Neuralstem Inc.:
|
Neurogenesis hippocampal stem cells depression stroke |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013