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Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145AM1)

Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Akathisia, Drug-Induced; Antipsychotic Agents; Movement Disorders

Intervention: Preladenant (Drug); Placebo (Drug); Preladenant (Drug); Anticholinergic agents or propanolol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Schering-Plough

Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

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 subjects with acute psychosis using the Barnes Akathisia Scale.

Clinical Details

Official title: Efficacy of SCH 420814 to Reduce the Frequency or Severity of Neuroleptic Induced Akathisia

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study

Primary outcome: Part 1: Incidence of akathisia; Part 2: Incidence of treatment failure

Secondary outcome:

Part 1 only: number of subjects that have a prevention failure (defined as the onset of akathisia)

Part 1: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS) Part 2: Global Clinical Impression, positive and negative symptom scale for schizophrenia (PANSS)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects or guardian must be willing to give written informed consent.

- Part 1 Only: Subjects with acute (not drug related) psychoses with a 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: Subjects 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 subjects who have developed akathisia as a result of

haloperidol at >=5 mg per day for the treatment of acute psychosis. The enrollment of subjects receiving other neuroleptics is allowed only after consultation and agreement by the sponsor.

- Subjects of either sex and of any race between the ages of 18 and 65 years,

inclusive.

- Subjects' clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be

within normal limits or clinically acceptable to the investigator/sponsor. Subject's liver function test results (ie, AST, ALT) must not be elevated above the normal

limits at Screening and on Day - 1/1.

- Subjects must be free of any clinically significant disease other than psychosis that

would interfere with the study evaluations.

- Screening 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) ~ spermicide,

- diaphragm or cervical cap ~ spermicide and condom,

- stable oral/transdermal/injectable hormonal contraceptive regimen without

breakthrough uterine bleeding for 2 months prior to Screening visit and a condom ~ spermicide,

- intrauterine device (inserted at least 2 months prior to Screening visit)

used 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.

- Subjects 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:

- Subjects who have a positive screen for drugs with a high potential for abuse.

Subjects that screen positive for cannabis are permitted.

- Subjects who have previously received this compound.

- Subjects who are currently participating in another clinical study or have

participated in a clinical study within 30 days (excepted subjects enrolled in the Part 1 of the P05145 study).

- Subjects who are part of the study staff personnel or family members of the study

staff personnel.

- Subjects with severe/uncontrolled hypertension will be excluded. Subjects with

hypertension well controlled on a stable dose of standard antihypertensive medication (excluding beta-blockers) will be eligible.

- Subjects with history of coronary artery disease including MI, or cerebrovascular

disease (stroke, TIA), or peripheral arterial disease.

- Subjects with congestive heart failure or subjects with ECGs consistent with ischemic

heart disease, sick sinus syndrome or significant Q waves.

- Subjects who are found to be at immediate risk of suicide.

- Female subjects pregnant or nursing.

- Subjects treated by Clozapine will be excluded. A washout period of 6 months prior to

dosing will be acceptable for study entry.

Locations and Contacts

SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734

Investigational Site 1, Johannesburg 2070, South Africa; Withdrawn

Investigational Site 2, Bellville 7530, South Africa; Recruiting

Investigational Site 3, Pretoria West 0183, South Africa; Recruiting

Investigational Site 4, Bloemfontein 9301, South Africa; Recruiting

Investigational Site 5, Aukland Park 2092, South Africa; Recruiting

Additional Information

Starting date: August 2007
Ending date: December 2008
Last updated: October 22, 2008

Page last updated: November 03, 2008

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