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Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.
ClinicalTrials.gov Identifier:
NCT01520649
First received: January 25, 2012
Last updated: April 1, 2014
Last verified: November 2012
  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:


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.


Enrollment: 26
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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:

  1. 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.
  2. Males and females 18 to 60 years of age, inclusive, at the time of informed consent.
  3. 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.

  4. Montgomery-Asberg Depression Scale (MADRS) score of 15 to 30, inclusive, at Screening and baseline.
  5. 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.
  6. The following applies to male subjects:
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520649

Locations
United States, California
California Clinical Trials
Glendale, California, United States
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: April 1, 2014
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2014