AzTrials
AzTrials

SchizophreniaPhase 2NCT01834638

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

A Phase 2 study testing ABT-126 in people with Schizophrenia, run by AbbVie at 51 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 to 66 years
Conditions the study is for
Schizophrenia
What is being tested?
ABT-126
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
51 sitesin 3 countries
Study dates
Mar 2013to Nov 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

51 sites in 3 countries.

51 sites in 3 countries

United States27 sites

  • Site Reference ID/Investigator# 95399

    Atlanta, Georgia, 30308

  • Site Reference ID/Investigator# 95379

    Cedarhurst, New York, 11516

  • Site Reference ID/Investigator# 120595

    Chicago, Illinois, 60640

  • Site Reference ID/Investigator# 95398

    Chino, California, 91710

  • Site Reference ID/Investigator# 95381

    Costa Mesa, California, 92626

  • Site Reference ID/Investigator# 95402

    DeSoto, Texas, 75115

  • Site Reference ID/Investigator# 95400

    Escondido, California, 92025

  • Site Reference ID/Investigator# 95406

    Garden Grove, California, 92845

  • Site Reference ID/Investigator# 129380

    Hoffman Estates, Illinois, 60169

  • Site Reference ID/Investigator# 95393

    Houston, Texas, 77008

  • Site Reference ID/Investigator# 95377

    Marietta, Georgia, 30060

  • Site Reference ID/Investigator# 95378

    National City, California, 91950

  • Site Reference ID/Investigator# 95382

    New Haven, Connecticut, 06519

  • Site Reference ID/Investigator# 95390

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 95386

    Oakland, California, 94612

  • Site Reference ID/Investigator# 95391

    Oceanside, California, 92056

  • Site Reference ID/Investigator# 95380

    Orange, California, 92868

  • Site Reference ID/Investigator# 95388

    Philadelphia, Pennsylvania, 19139

  • Site Reference ID/Investigator# 95395

    Pico Rivera, California, 90660

  • Site Reference ID/Investigator# 95403

    Riverside, California, 92506

  • Site Reference ID/Investigator# 95392

    Rochester, New York, 14623

  • Site Reference ID/Investigator# 128356

    San Bernardino, California, 92408

  • Site Reference ID/Investigator# 95405

    San Diego, California, 92102

  • Site Reference ID/Investigator# 95397

    San Diego, California, 92103

  • Site Reference ID/Investigator# 95384

    San Gabriel, California, 91776

  • Site Reference ID/Investigator# 95385

    Santa Ana, California, 92705

  • Site Reference ID/Investigator# 95387

    Torrance, California, 90502

Other trials in United States

Russia19 sites

  • Site Reference ID/Investigator# 117189

    Chita, 672090

  • Site Reference ID/Investigator# 117188

    Kazan', 420061

  • Site Reference ID/Investigator# 117175

    Lipetsk, 399083

  • Site Reference ID/Investigator# 117159

    Moscow, 109559

  • Site Reference ID/Investigator# 117183

    Moscow, 115419

  • Site Reference ID/Investigator# 117182

    Novosibirsk, 630091

  • Site Reference ID/Investigator# 117157

    Saint Petersburg, 190020

  • Site Reference ID/Investigator# 117185

    Saint Petersburg, 190121

  • Site Reference ID/Investigator# 117192

    Saint Petersburg, 191119

  • Site Reference ID/Investigator# 117193

    Saint Petersburg, 191119

  • Site Reference ID/Investigator# 117176

    Saint Petersburg, 192019

  • Site Reference ID/Investigator# 117195

    Saint Petersburg, 195176

  • Site Reference ID/Investigator# 117186

    Saint Petersburg, 197341

  • Site Reference ID/Investigator# 117156

    Saratov, 410028

  • Site Reference ID/Investigator# 117177

    Saratov, 410060

  • Site Reference ID/Investigator# 117180

    Stavropol, 357034

  • Site Reference ID/Investigator# 117181

    Yaroslavl, 150003

  • Site Reference ID/Investigator# 117194

    Yekaterinburg, 620028

  • Site Reference ID/Investigator# 117178

    Yekaterinburg, 620030

Other trials in Russia

United Kingdom5 sites

  • Site Reference ID/Investigator# 117422

    Edinburgh, EH10 5HF

  • Site Reference ID/Investigator# 117423

    London, SE5 8AF

  • Site Reference ID/Investigator# 117425

    London, W6 8RP

  • Site Reference ID/Investigator# 117424

    Newcastle upon Tyne, NE4 5PL

  • Site Reference ID/Investigator# 117419

    Oxford, OX3 7JX

Other trials in United Kingdom

About this study

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

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).

Conditions
Schizophrenia
Being tested
ABT-126
Keywords
schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-126Drug

    capsule(s)

Study groups in NCT01834638
Study groupRoleWhat they receive
ABT-126 low doseExperimentalABT-126 low dose
Receives: Drug: ABT-126
ABT-126 middle doseExperimentalABT-126 middle dose
Receives: Drug: ABT-126
ABT-126 high doseExperimentalABT-126 high dose
Receives: Drug: ABT-126

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects with adverse events

    Measured: up to 52 weeks

  2. Change in laboratory test results

    Measured: from Day -1 to Week 52

  3. Change in vital signs

    Measured: from Day -1 to Week 52

  4. Change in electrocardiogram (ECG) data

    Measured: from Day -1 to Week 52

Secondary outcomes (4)

  1. Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)

    rater based interview

    Measured: from Day -1 to Week 52

  2. Change in University of California San Diego Performance-Based Skills Assessment-2 (UPSA-2ER)

    rater based interview to evaluate functioning

    Measured: from Day -1 to Week 52

  3. Change in the Positive and Negative Syndrome Scale (PANSS)

    rater based interview to assess functioning

    Measured: from Day -1 to Week 52

  4. Change in the 16-item version of the Negative Symptom Assessment Scale (NSA-16)

    rater based interview to assess symptom severity

    Measured: from Day -1 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Study endpoint in preceding base study M10-855 not met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01834638
Sponsor's protocol ID
M13-765
Other IDs
2012-005661-13
Status last verified
Oct 2014
First submitted
16 Apr 2013
Last updated
2 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Haig G, Wang D, Othman AA, Zhao J. The alpha7 Nicotinic Agonist ABT-126 in the Treatment of Cognitive Impairment Associated with Schizophrenia in Nonsmokers: Results from a Randomized Controlled Phase 2b Study. Neuropsychopharmacology. 2016 Nov;41(12):2893-2902. doi: 10.1038/npp.2016.101. Epub 2016 Jun 20.

    PubMed 27319970

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-126 in people with Schizophrenia, run by AbbVie at 51 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Russia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study endpoint in preceding base study M10-855 not met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with adverse events (time frame: up to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01834638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in