Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia
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| ClinicalTrials.gov Identifier: NCT00968851 |
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Recruitment Status :
Completed
First Posted : August 31, 2009
Last Update Posted : April 25, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Central Nervous System Diseases Cognition | Drug: EVP-6124 Drug: Placebo | Phase 2 |
This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of EVP-6124 when administered concomitantly with anti-psychotic medication.
Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 317 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | March 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: EVP-6124 0.3 mg
one 0.3 mg capsule every day for 84 days
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Drug: EVP-6124
Arms: 1 |
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Active Comparator: EVP-6124 1.0 mg
one 1.0 mg capsule every day for 84 days.
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Drug: EVP-6124
Arms: 2 |
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Placebo Comparator: Placebo
Placebo every day for 84 days
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Drug: Placebo
Arm: 3 |
- Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function. [ Time Frame: 84 days ]
- Assessment of Clinical Efficacy [ Time Frame: 84 days ]
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
- Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
- Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
- A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
- A minimal level of depression; Calgary Depression Scale total score ≤10
- Must have a general health status acceptable for participation in a 12-week clinical trial
- Fluency (oral and written) in the language in which the standardized tests will be administered
- If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing
Exclusion Criteria:
General
- Insufficiently controlled diabetes mellitus in the judgment of the investigator
- Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
- Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
- Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
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): NCT00968851
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| Study Director: | Chris Southard | Syneos Health |
| Responsible Party: | FORUM Pharmaceuticals Inc |
| ClinicalTrials.gov Identifier: | NCT00968851 |
| Other Study ID Numbers: |
EVP-6124-009 |
| First Posted: | August 31, 2009 Key Record Dates |
| Last Update Posted: | April 25, 2014 |
| Last Verified: | March 2012 |
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Schizophrenia Central nervous System Diseases Cognition |
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Nervous System Diseases Central Nervous System Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |