SchizophreniaPhase 1NCT00888693
A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
A Phase 1 study testing ABT-288 in people with Schizophrenia, run by AbbVie.
Trial summary
Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ABT-288
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 2009
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has signed informed consent;
- Current DSM-IV-TR diagnosis of schizophrenia;
- Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
- Meets study-specific PANSS criteria;
- Willing and able to cooperate with cognitive testing
- Females are not pregnant, not breast-feeding;
- Females are post-menopausal or surgically sterile or practicing birth control;
- Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
Who cannot join
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Diagnosis of schizoaffective disorder;
- Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
- Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
- Current clozapine treatment; suicidal ideation or behavior;
- BMI of 39 or greater; current homicidal or violent ideation;
Show all 11Show fewer
- Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
- Positive hepatitis or HIV test result;
- Recent clinically significant illness/infection or surgery;
- Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
- Visual, hearing or communication disability
About this study
Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
- Conditions
- Schizophrenia
- Being tested
- ABT-288, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-288Drug
See Arm Description for details.
PlaceboDrug
See Arm Description for details.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 2 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 3 | Experimental | ABT-288 vs placebo capsules administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 4 | Experimental | ABT288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 5 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 6 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 7 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 8 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
| 9 | Experimental | ABT-288 vs placebo administered orally once daily for 14 days Receives: Drug: ABT-288; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
Measured: Days -1 to 21
Pharmacokinetics; optional CSF for arms 7, 8 & 9
Measured: Days -1 to 21
Secondary outcomes (4)
Extrapyramidal Symptom Rating Scale
Measured: Day -1, Day 14
Columbia Suicide Severity Rating Scale
Measured: Screening, Day 15
Pharmacodynamics: CANTAB & PANSS
Measured: Screening, Day -1, Day 14
Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified
Measured: Day -1, Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888693
- Sponsor's protocol ID
- M10-752
- Status last verified
- Oct 2010
- First submitted
- 27 Apr 2009
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.
PubMed 24215171
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT00888693
- Acronym / sponsor ID
- M10-752
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo capsules administered orally once daily for 14 days |
| 2 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo capsules administered orally once daily for 14 days |
| 3 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo capsules administered orally once daily for 14 days |
| 4 | Experimental | Drug: ABT-288, Drug: PlaceboABT288 vs placebo administered orally once daily for 14 days |
| 5 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo administered orally once daily for 14 days |
| 6 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo administered orally once daily for 14 days |
| 7 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo administered orally once daily for 14 days |
| 8 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo administered orally once daily for 14 days |
| 9 | Experimental | Drug: ABT-288, Drug: PlaceboABT-288 vs placebo administered orally once daily for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject has signed informed consent;
- Current DSM-IV-TR diagnosis of schizophrenia;
- Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
- Meets study-specific PANSS criteria;
- Willing and able to cooperate with cognitive testing
Key exclusion criteria (11 listed)
- Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- Diagnosis of schizoaffective disorder;
- Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
- Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
- Current clozapine treatment; suicidal ideation or behavior;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-288See Arm Description for details. | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| PlaceboSee Arm Description for details. | Drug | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
Time frame: Days -1 to 21
Pharmacokinetics; optional CSF for arms 7, 8 & 9
Time frame: Days -1 to 21
4 secondary outcomes
Extrapyramidal Symptom Rating Scale
Time frame: Day -1, Day 14
Columbia Suicide Severity Rating Scale
Time frame: Screening, Day 15
Pharmacodynamics: CANTAB & PANSS
Time frame: Screening, Day -1, Day 14
Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified
Time frame: Day -1, Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 24215171Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-288 in people with Schizophrenia, run by AbbVie.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests, (time frame: Days -1 to 21). The study lists 2 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 NCT00888693, 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 21 Nov 2017.