Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

NCT02970292 | Completed Phase 3 Results DMC

• 2 other identifiers: ACP-103-0342016-003434-24
• Study Type: interventional
• Target: 396
• Locations: 10 countries
• Sites: 105

Brief Summary

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

  The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.

  From baseline to Week 6

Secondary Outcomes (8)

• Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score

  From baseline to Week 6

• Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score

  From baseline to Week 6

• PANSS Responders

  From baseline to Week 6

• Clinical Global Impression-Improvement (CGI-I) Response

  From baseline to Week 6

• Clinical Global Impression-Improvement (CGI-I) Score at Week 6

  From baseline to Week 6

Study Arms (2)

Pimavanserin

EXPERIMENTAL

Drug- pimavanserin 34 mg, 20 mg, or 10 mg taken as two tablets + background antipsychotic, once daily by mouth

Drug: Pimavanserin

Placebo

PLACEBO COMPARATOR

Placebo + background antipsychotic, taken as two tablets, once daily by mouth

Drug: Placebo

Interventions

Pimavanserin DRUG

Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth

Pimavanserin

Placebo DRUG

Placebo, taken as two tablets, once daily by mouth

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults patients, between 18 and 55 years of age
• A clinical diagnosis of schizophrenia with a minimum duration of 1 year
• The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:
• Aripiprazole
• Aripiprazole long-acting injectables:
• Abilify Maintena®
• Aristada®
• Risperidone
• Risperidone long-acting injection
• Olanzapine
• Lurasidone
• Cariprazine
• Brexpiprazole
• Asenapine
• Has had a partial but inadequate response to antipsychotic treatment

You may not qualify if:

• Patient has a psychiatric disorder other than schizophrenia
• Patient has a history of resistance to antipsychotic treatment
• A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana
• a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
• Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
• Patient has had a myocardial infarction in the last six months
• Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome
• Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (105)

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Phoenix, Arizona, 85012, United States

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Little Rock, Arkansas, 72211, United States

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Rogers, Arkansas, 72758, United States

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Bellflower, California, 90706, United States

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Cerritos, California, 90703, United States

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Culver City, California, 90230, United States

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Lemon Grove, California, 91945, United States

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Long Beach, California, 90822, United States

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San Diego, California, 92103, United States

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San Diego, California, 92123, United States

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Santa Ana, California, 92705, United States

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Torrance, California, 90502, United States

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Boca Raton, Florida, 33431, United States

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Lauderhill, Florida, 33319, United States

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Miami, Florida, 33122, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30331, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Hoffman Estates, Illinois, 60169, United States

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Lake Charles, Louisiana, 70629, United States

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Catonsville, Maryland, 21228, United States

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Ann Arbor, Michigan, 48105, United States

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Las Vegas, Nevada, 89102, United States

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Berlin, New Jersey, 08009, United States

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Cedarhurst, New York, 11516, United States

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Jamaica, New York, 11432, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28211, United States

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Dayton, Ohio, 45417, United States

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Charleston, South Carolina, 29407, United States

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Richardson, Texas, 75080, United States

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Salt Lake City, Utah, 84105, United States

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Burgas, 8000, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Plovdiv, 4000, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1408, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1680, Bulgaria

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Targovishte, 7700, Bulgaria

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Tserova Koria, 5047, Bulgaria

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Varna, 9020, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Veliko Tarnovo, 5047, Bulgaria

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Vratsa, 3000, Bulgaria

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Chatham, Ontario, N7L1C1, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Toronto, M6J 1H4, Canada

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Hradec Králové, 503 41, Czechia

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Pilsen, 312 00, Czechia

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Prague, 100 00, Czechia

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Prague, 106 00, Czechia

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Prague, 160 00, Czechia

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Říčany, 251 01, Czechia

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Kalocsa, Bács-Kiskun Megya, 6300, Hungary

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Budapest, Pest County, 1036, Hungary

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Budapest, Pest County, 1083, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7633, Hungary

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Kaunas, 44279, Lithuania

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Kaunas, 48259, Lithuania

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Kaunas, 50185, Lithuania

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Šilutė, 99142, Lithuania

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Vilnius, 09112, Lithuania

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Bialystok, 15 756, Poland

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Bydgoszcz, 85 080, Poland

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Lublin, 20 080, Poland

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Lublin, 20 582, Poland

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Pruszcz Gdański, 83 000, Poland

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Roshchino, Leningradskaya Oblast', 188820, Russia

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Plekhanovo, Lipetsk Oblast, 399313, Russia

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Tonnel’nyy, Stavropol Kray, 357034, Russia

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Arkhangelsk, 163530, Russia

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Moscow, 115522, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 193167, Russia

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Saint Petersburg, 195112, Russia

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Saint Petersburg, 197341, Russia

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Samara, 443016, Russia

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Smolensk, 214019, Russia

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Stavropol, 355038, Russia

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Voronezh, 394024, Russia

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Yaroslavl, 150003, Russia

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Belgrade, 11 000, Serbia

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Belgrade, 11000, Serbia

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Kovin, 26 220, Serbia

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Kragujevac, 34 000, Serbia

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Niš, 18 000, Serbia

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Kherson, Vil. Stepanivka, 73488, Ukraine

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Dnipro, 49005, Ukraine

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Hlevakha, 08631, Ukraine

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Kharkiv, 61068, Ukraine

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Kyiv, 01133, Ukraine

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Kyiv, 02192, Ukraine

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Kyiv, 04080, Ukraine

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Kyiv, 08631, Ukraine

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Odesa, 65014, Ukraine

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Oleksandrivka, 67513, Ukraine

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Poltava, 36013, Ukraine

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Smila, 08631, Ukraine

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Smila, 20708, Ukraine

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Vinnytsia, 21005, Ukraine

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Related Publications (1)

• Bugarski-Kirola D, Abbs B, Odetalla R, Liu IY, Darwish M, DeKarske D. Adherence to Background Antipsychotic and Pimavanserin in Patients with Schizophrenia: Post Hoc Analyses from the ENHANCE and ADVANCE Studies. Patient Prefer Adherence. 2024 Jan 19;18:207-216. doi: 10.2147/PPA.S436041. eCollection 2024.

  PMID: 38264323 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

pimavanserin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Sr. Dir. Medical Information and Medical Communications
• Organization: ACADIA Pharmaceuticals Inc.

medicalinformation@acadia-pharm.com

+1-858-261-2897

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 22, 2016
• Study Start: October 26, 2016
• Primary Completion: May 28, 2019
• Study Completion: June 25, 2019
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BU (14); LI (5); UA (14); SE (5); CA (3); CZ (6); HU (5); US (33); RU (15); PL (5)