Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)

NCT ID: NCT00693472

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-15
• Study Completion Date: 2009-01-09

Brief Summary

This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.

Conditions

Akathisia, Drug-Induced; Antipsychotic Agents; Movement Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Preladenant

Preladenant 25 mg every 12 hours for 13 days

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

Preladenant, one 25 mg capsule, administered orally every 12 hours

Anticholinergic agents or propanolol

Intervention Type: DRUG

Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol.

Haloperidol

Intervention Type: DRUG

Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Part 1: Placebo

Placebo every 12 hours for 13 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo capsule administered orally every 12 hours

Anticholinergic agents or propanolol

Intervention Type: DRUG

Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol.

Haloperidol

Intervention Type: DRUG

Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Part 2: Preladenant

Preladenant 25 mg every 12 hours for 13 days

Group Type: EXPERIMENTAL

Preladenant

Intervention Type: DRUG

Preladenant, one 25 mg capsule, administered orally every 12 hours

Haloperidol

Intervention Type: DRUG

Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Part 2: Standard of Care

Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)

Group Type: ACTIVE_COMPARATOR

Anticholinergic agents or propanolol

Intervention Type: DRUG

Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol.

Haloperidol

Intervention Type: DRUG

Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Interventions

Preladenant

Preladenant, one 25 mg capsule, administered orally every 12 hours

Intervention Type: DRUG

Placebo

Matching placebo capsule administered orally every 12 hours

Intervention Type: DRUG

Anticholinergic agents or propanolol

Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol.

Intervention Type: DRUG

Haloperidol

Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Intervention Type: DRUG

Other Intervention Names

SCH 420814

Eligibility Criteria

Inclusion Criteria

• Participants or guardian must be willing to give written informed consent.
• Part 1 Only: Participants with acute (not drug related) psychoses with a Positive and Negative Symptom Scale for Schizophrenia (PANSS) score of at least 60: schizophrenia, schizo-affective, schizo-manic, and acute mania with a history of previous treatment with neuroleptics.
• Part 1 Only: Participants initiating haloperidol for the treatment of an acute psychotic episode at a dose of at least 7.5 mg per day.
• Part 2 Only: Inpatient participants who have developed akathisia as a result of haloperidol at >=5 mg per day for the treatment of acute psychosis. The enrollment of participants receiving other neuroleptics is allowed only after consultation and agreement by the sponsor.
• Participants of either sex and of any race between the ages of 18 and 65 years, inclusive.
• Participant's clinical laboratory tests (complete blood count [CBC], blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participant's liver function test results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT]) must not be elevated above the normal limits at Screening and on Day -1/1.
• Participants must be free of any clinically significant disease other than psychosis that would interfere with the study evaluations.
• Screening electrocardiogram (ECG) must be clinically acceptable to the investigator.
• Female of childbearing potential must:

• Have used a medically accepted method of contraception for 1 month (or abstained from sexual intercourse) prior to the screening period. An acceptable method of contraception includes one of the following:

• condom (male or female) used with spermicide,
• diaphragm or cervical cap used with spermicide and condom,
• stable oral/transdermal/injectable hormonal contraceptive regimen without breakthrough uterine bleeding for 2 months prior to Screening visit and a condom used with spermicide,
• intrauterine device (inserted at least 2 months prior to Screening visit) used with spermicide.

Note: Vasectomy of the partner is not considered sufficient contraception and one of the 4 bulleted methods listed above must be used.

• Agree to use one of the accepted methods of contraception (listed above) during the trial (including the screening period prior to receiving trial medication), and for 1 month after stopping the trial medication.
• Participants enrolled in the placebo arm of Part 1 and who developed akathisia may be eligible for Part 2 in the standard of care arm.

Exclusion Criteria

• Participants who have a positive screen for drugs with a high potential for abuse. Participants that screen positive for cannabis are permitted.
• Participants who have previously received this compound.
• Participants who are currently participating in another clinical study or have participated in a clinical study within 30 days (except participants enrolled in the Part 1 of the P05145 study).
• Participants who are part of the study staff personnel or family members of the study staff personnel.
• Participants with severe/uncontrolled hypertension will be excluded. Participants with hypertension well controlled on a stable dose of standard antihypertensive medication (excluding beta-blockers) will be eligible.
• Participants with history of coronary artery disease including myocardial infarction (MI), or cerebrovascular disease (stroke, transient ischemic attack [TIA]), or peripheral arterial disease.
• Participants with congestive heart failure or participants with ECGs consistent with ischemic heart disease, sick sinus syndrome or significant Q waves.
• Participants who are found to be at immediate risk of suicide.
• Female participants pregnant or nursing.
• Participants treated by Clozapine will be excluded. A washout period of 6 months prior to dosing will be acceptable for study entry.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-3814-019

Identifier Type: OTHER

Identifier Source: secondary_id

P05145

Identifier Type: -

Identifier Source: org_study_id