Study of Preladenant for the Treatment of Antipsychotic Induced Movement Disorders in Subjects With Schizophrenia (Study P04628)(TERMINATED)

This study has been terminated.
(Study terminated after 9 subjects completed due to lack of enrollment for 6 months)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686699
First received: May 27, 2008
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

This study is designed to determine if preladenant can reduce drug-induced involuntary movements in subjects with schizophrenia or schizoaffective disorder. Subjects will be evaluated for two, 14 day treatment periods with a 3 week washout period between treatment periods. The primary variable, Extrapyramidal Symptom Rating Score (ESRS), will be evaluated frequently during the treatment periods.


Condition Intervention Phase
Akathisia, Drug-Induced
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Drug: Preladenant
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Multiple Dose, Placebo Controlled, Randomized, Two Way Crossover Study to Assess the Efficacy of SCH 420814 in Reducing Anti Psychotic-Induced Extra Pyramidal Symptoms Among Subjects With Schizophrenia and Schizoaffective Disorders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Lowest Extrapyramidal Symptom Rating Score (ESRS) total score within the 6 hour evaluation [ Time Frame: Morning Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean ESRS subscores during 6 hours post treatment. [ Time Frame: Morning Day 14 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
During the 14 day treatment period, subjects will receive preladenant 25 mg BID.
Drug: Preladenant
one 25 mg capsule twice daily for 14 days
Other Name: SCH 420814
Placebo Comparator: Treatment B
During the 14 day treatment period, subjects will receive matching placebo BID.
Drug: Placebo
one 25 mg matching capsule twice daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females >=18 and <=65 years old with a body mass index of 17-31 kg/m^2.
  • Subjects with DSM-IV criteria for schizophrenia/schizoaffective (depressive type) disorder with antipsychotic-induced extrapyramidal symptoms (parkinsonism, akathisia, dystonia, or tardive dyskinesia [TD]) based on the following ESRS criteria:

    • parkinsonism, dystonia, or TD - ESRS score >=2 on 2 items or >=3 on one item,
    • akathisia - ESRS score >=3 on two items,
  • Subjects whose total ESRS score >8.
  • Subjects must be receiving neuroleptics at a stable dosage for at least 7 days prior to enrollment.
  • Clinical laboratory tests, physical exam, and electrocardiogram must be within normal limits or clinically acceptable to the investigator/sponsor (except signs and symptoms of Schizophrenia/Schizoaffective disorder).
  • Subjects liver function tests must be within normal limits at screening.
  • Subjects screen for drugs with a high potential for abuse must be negative.
  • Subjects must be free of any clinically significant disease other than schizophrenia/schizoaffective disorder that would interfere with the study evaluations or procedures.
  • Subjects must have a level of understanding sufficient to communicate with research staff, cooperate with all protocol required tests and examinations, and be able to adhere to protocol restrictions and schedules.
  • Subjects must be able to understand the nature of the study and must be willing to sign an informed consent (required for each patient or the patient's authorized legal representative) prior to study enrollment.
  • Females must have a FSH >=40 lU/L and be greater than 12 months since last menses or surgically sterilized.

Exclusion Criteria:

  • Subjects who have a history of clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration, clinically significant food or drug allergy, seizures, alcohol/drug dependence, previous neurosurgery, or coronary artery disease (including MI, cerebrovascular disease [stroke, TIA], or peripheral arterial disease).
  • Subjects who have participated in a clinical trial of an investigational drug within 60 days or donated blood within the preceding 90 days prior to the start of the study.
  • Subjects with circulating HIV, hepatitis C antibodies, or hepatitis B surface antigen.
  • Subjects who are allergic to preladenant (SCH 420814) or any excipients in preladenant capsules (citric acid, lactose monohydrate, croscarmellose sodium, magnesium stearate [nonbovine, vegetable grade], FD&C blue, titanium dioxide, gelatin-NF).
  • Females who are not surgically sterilized or postmenopausal.
  • Male subjects who are sexually active and who do not agree to use a barrier method of birth control during the study.
  • Subjects with severe/uncontrolled hypertension. (Subjects with hypertension well controlled on a stable dose of standard anti-hypertensive medication for at least 4 weeks before randomization are eligible.)
  • Subjects with atrioventricular (AV) block, sick sinus syndrome, congestive heart failure, or subjects with ECGs consistent with ischemic heart disease, or significant Q waves.
  • Subjects with DSM-IV criteria of dementia (except due to schizophrenia/and schizoaffective disorder), or individuals who in the opinion of the investigator are not able to understand or comply with the study procedures or the instructions of the staff or are socially incapable to participate in the study.
  • Individuals who do not comply with the requirement that they should not use any drugs (except acetaminophen and other allowed medications) within 2 weeks prior to the study, nor alcohol (wine, beer) within 72 hours prior to drug administration.
  • Subjects who were judged clinically to be at suicidal risk too serious to be included in this study.
  • Subjects who had received electroconvulsive therapy within 30 days before randomization.
  • Subjects who are currently taking Clozapine.
  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: NCT00686699     History of Changes
Other Study ID Numbers: P04628, 2005-006048-42
Study First Received: May 27, 2008
Last Updated: September 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Dyskinesias
Dyskinesia, Drug-Induced
Movement Disorders
Psychotic Disorders
Schizophrenia
Akathisia, Drug-Induced
Parkinsonian Disorders
Psychomotor Agitation
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug Toxicity
Poisoning
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Basal Ganglia Diseases
Brain Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Antipsychotic Agents
Anti-Dyskinesia Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014