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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00693472
First received: May 27, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Akathisia, Drug-Induced
Antipsychotic Agents
Movement Disorders
Drug: Preladenant
Drug: Placebo
Drug: Anticholinergic agents or propanolol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of SCH 420814 to Reduce the Frequency or Severity of Neuroleptic Induced Akathisia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Part 1: Incidence of akathisia; Part 2: Incidence of treatment failure [ Time Frame: Day 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 1 only: number of subjects that have a prevention failure (defined as the onset of akathisia) [ Time Frame: Day 13 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: August 2007
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Treatment A Preladenant Drug: Preladenant
one 25 mg capsule twice daily for 13 days
Other Name: SCH 420814
Placebo Comparator: Part 1: Treatment B Placebo Drug: Placebo
Matching placebo capsule twice daily for 13 days
Experimental: Part 2: Treatment C Preladenant Drug: Preladenant
one 25 mg capsule twice daily for 13 days
Other Name: SCH 420814
Active Comparator: Part 2: Treatment D Standard of Care Drug: Anticholinergic agents or propanolol
Standard of care; Anticholinergic agents or propanolol as determined by the investigator according to the local standard of care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00693472     History of Changes
Other Study ID Numbers: P05145
Study First Received: May 27, 2008
Last Updated: December 18, 2013
Health Authority: South Africa: Medicines Control Council

Keywords provided by Merck Sharp & Dohme Corp.:
Antipsychotic Agents

Additional relevant MeSH terms:
Movement Disorders
Akathisia, Drug-Induced
Central Nervous System Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Cholinergic Antagonists
Antipsychotic Agents
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014