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Long-term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: An Extension Study for Subjects Completing Study M10-855 (NCT01655680)

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ClinicalTrials.gov Identifier: NCT01834638
Recruitment Status : Terminated (Study endpoint in preceding base study M10-855 not met.)
First Posted : April 18, 2013
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This is a study of ABT-126 in the treatment of cognitive impairment associated with schizophrenia (CIAS), a long-term extension study to study M10-855 (NCT01655680).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ABT-126 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Safety and Efficacy of ABT-126 in Subjects With Schizophrenia: A Double-Blind Extension Study for Subjects Completing Study M10-855
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ABT-126 low dose
ABT-126 low dose
Drug: ABT-126
capsule(s)

Experimental: ABT-126 middle dose
ABT-126 middle dose
Drug: ABT-126
capsule(s)

Experimental: ABT-126 high dose
ABT-126 high dose
Drug: ABT-126
capsule(s)




Primary Outcome Measures :
  1. Percentage of subjects with adverse events [ Time Frame: up to 52 weeks ]
  2. Change in laboratory test results [ Time Frame: from Day -1 to Week 52 ]
  3. Change in vital signs [ Time Frame: from Day -1 to Week 52 ]
  4. Change in electrocardiogram (ECG) data [ Time Frame: from Day -1 to Week 52 ]

Secondary Outcome Measures :
  1. Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) [ Time Frame: from Day -1 to Week 52 ]
    rater based interview

  2. Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER) [ Time Frame: from Day -1 to Week 52 ]
    rater based interview to evaluate functioning

  3. Change in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: from Day -1 to Week 52 ]
    rater based interview to assess functioning

  4. Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16) [ Time Frame: from Day -1 to Week 52 ]
    rater based interview to assess symptom severity



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject was randomized into Study M10-855 and completed through Week 26 in that study.
  • The subject is receiving one or more antipsychotic medications.

Exclusion Criteria:

  • Additional history collected during participation in Study M10-855 provides evidence that, in the investigator's judgement, the subject does not have schizophrenia.
  • The subject experienced an adverse event or abnormal finding during physical examination, vital signs, laboratory profile, and/or electrocardiogram (ECG) measurements in Study M10-855 that indicates the subject is likely to become medically unstable during the current study.
  • The subject is currently taking or is expected to be prescribed any excluded medication without the approval of AbbVie medical monitor.
  • The subject is currently enrolled in, or plans to participate in, another interventional study during the course of this trial.

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): NCT01834638


  Show 51 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: George Haig, PharmD AbbVie

Publications of Results:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01834638     History of Changes
Other Study ID Numbers: M13-765
2012-005661-13 ( EudraCT Number )
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: October 2014
Keywords provided by AbbVie:
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders