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Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202226
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lu AF35700 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomised, Double-blind, Placebo-controlled, Sequential Group, Multiple Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF35700 in Patients With Schizophrenia
Study Start Date : January 2013
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lu AF35700 oral solution (1 mg/mL)
Planned daily doses range from 5 mg/day to 30 mg/day for 3 weeks. Weekly doses up to 75 mg/week for 3 weeks.
 Drug: Lu AF35700
Placebo Comparator: Matching placebo
Oral solution
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG) [ Time Frame: Screening to day 78 (up to 8 weeks after last dose) ]
  2. Change from baseline in AIMS, BARS and SAS Total score [ Time Frame: Baseline to day 21 ]
    Abnormal movement rating scale

  3. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Sceening to day 78 (up to 8 weeks after last dose) ]

Secondary Outcome Measures :
  1. Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime [ Time Frame: Day 21 in the dosing period ]
  2. Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152 [ Time Frame: Day 1 and 21 in the dosing period ]
  3. Half-lives (t½) of Lu AF35700 and Lu AF36152 [ Time Frame: Day 1 and 21 in the dosing period ]
  4. Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen [ Time Frame: Day 14-21 in the dosing period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women between 18 and 60 years (extremes included)
  • BMI of ≤38
  • Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
  • Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
  • PANSS total score ≤80
  • Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
  • Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit

Exclusion Criteria:

  • The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
  • The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
  • The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
  • The patient smokes >20 cigarettes per day

Other protocol-defined inclusion and exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202226


Locations
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United States, California
PAREXEL Phase I Unit
Glendale, California, United States, 91206
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H.Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02202226    
Other Study ID Numbers: 14754A
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders