NCT00125138

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of three target doses of melperone compared to placebo in the treatment of psychosis associated with Parkinson's disease. Subjects will be enrolled at approximately 20 investigational sites in the United States (U.S.) and 15 Ex-US sites. The maximum study duration will be 10 weeks. Subjects will have the option of continuing in an open-label extension study.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
3 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 17, 2011

Completed
Last Updated

June 17, 2011

Status Verified

May 1, 2011

Enrollment Period

2.7 years

First QC Date

July 27, 2005

Results QC Date

April 11, 2011

Last Update Submit

May 17, 2011

Conditions

Parkinson's DiseasePsychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Patient Evaluation of Symptoms of Psychosis.

    The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.

    6 weeks (from Baseline to end of Maintenance Period)

Secondary Outcomes (1)

  • Investigator/Caregiver Evaluations of Motor Function

    6 weeks (from Baseline to end of Maintenance Period)

Study Arms (4)

Melperone HCl - 20 mg

EXPERIMENTAL
Drug: Melperone HCl

Melperone HCl - 40 mg

EXPERIMENTAL
Drug: Melperone HCl

Melperone HCl - 60 mg

EXPERIMENTAL
Drug: Melperone HCl

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Melperone HClDRUG

20 mg/day. Strength of melperone syrup is 5 mg/mL

Melperone HCl - 20 mg
PlaceboDRUG

Syrup formulation

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The subject or subject's legally authorized representative (LAR) must sign and date the IRB/IEC approved Informed Consent Form and HIPAA Authorization (applicable to US sites only) prior to study participation.
  • Male or female subjects. If female:
  • Subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if of childbearing potential, must comply with a method of birth control acceptable to the investigator during the study, for at least one month prior to randomization and for one month following completion of the study.
  • Subject is not breastfeeding
  • Subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and on Day 1.
  • Subjects with a clinical diagnosis of idiopathic Parkinson's Disease, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
  • Rest tremor
  • Rigidity
  • Bradykinesia and/or akinesia
  • Postural and gait abnormalities
  • Subjects with psychosis:
  • Presence of visual and/or auditory hallucinations, with or without delusions, occurring during the four weeks prior to the screening visit.
  • Symptoms severe enough to clinically warrant treatment with an antipsychotic agent.
  • A Hallucinations or Delusions total item score (frequency x severity) of \> 4 on the Neuropsychiatric Inventory (NPI).
  • Subjects currently being treated with an antipsychotic agent who have not had visual and/or auditory hallucinations, with or without delusions, during the four weeks prior to screening, and/or have a Hallucinations or Delusions total item score \<4 on the NPI at the screening visit may be washed out (for 7 days or 5 half-lives, whichever is longer) and return for a repeat screening visit. The NPI Hallucinations or Delusions total item score must be ≥4 at the repeat visit to be considered for study entry.
  • +2 more criteria

You may not qualify if:

  • Subject has any systemic factor contributing to the psychosis such as urinary infection, liver disease, renal failure, anemia, infection or cancer.
  • Subject has a history of significant psychotic disorders prior to the diagnosis of Parkinson's Disease, including but not limited to schizophrenia or bipolar disorder.
  • Subject has Dementia with Lewy-bodies (DLB).
  • Subject has dementia or a major depressive disorder precluding accurate assessment on rating scales.
  • Subject has an acute depressive episode at the time of the screening visit.
  • A score on the Mini-Mental State Examination (MMSE) of \< 21.
  • Subject has had a dose adjustment of their antidepressant medication within 30 days prior to the screening visit, or dose adjustments are planned during the duration of the trial.
  • Subject has had dose adjustments of an anxiolytic, cognitive enhancer, or other psychotropic medication (excluding antipsychotics) within 30 days prior to screening or dose adjustments are planned during the duration of the trial.
  • Subject has received depot antipsychotic agents within the past 3 months.
  • Subject has previously failed treatment with clozaril for psychosis in Parkinson's disease. Subjects who discontinued clozaril due to intolerability may be enrolled.
  • Subject has used any investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • Subject cannot tolerate a wash-out of antipsychotic medication prior to randomization.
  • Subject has a history of a serious respiratory, gastrointestinal, renal, hematologic or other medical disorder.
  • Subject has a history of a serious cardiovascular condition (including, but not limited to, Class IV angina or Class IV heart failure) and/or a history of risk factors for Torsade de pointes (Tdp) (including but not limited to current treatment for hypokalemia or family history of long QT syndrome).
  • Subject had myocardial infarction within 6 months prior to screening.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Northwest Neurospecialists, PLLC

Tucson, Arizona, 85741, United States

Location

Bradenton Research Center, Inc

Bradenton, Florida, 34205, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Struthers Parkinson's Center, Park Nicollet Health Services

Golden Valley, Minnesota, 55427, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Neurology Consultants of the Carolinas

Charlotte, North Carolina, 28204, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Neurology Associates

San Antonio, Texas, 78217, United States

Location

Department of Neurology, Rajendra Prasad Ward, King George Hospital, Visakhapatnam

Visakhapatnam, Andhra Pradesh, 530 002, India

Location

Department of Neurology, Manipal Hospital

Bangalore, Karnataka, 560017, India

Location

M. S. Ramasah Memorial Hospital

Bangalore, Karnataka, 560054, India

Location

KLE Hospital, Belgaum

Belagavi, Karnataka, 590 010, India

Location

Kasturra Medical College, Hospital, Attavar

Mangalore, Karnataka, 575 001, India

Location

SCTIMST

Trivandrum, Kerla, 695 011, India

Location

Jaslok Hospital and Research Center

Mumbai, Maharashtra, 400 026, India

Location

Apollo Hospitals Educational and Research Foundation

Chennai, Tamil Nadu, 600 006, India

Location

Fondazione Universita di Chieti C.E.S.I. Centro Studi sull'Invecchiamento

Chieti Scalo, Ambruzzo, 66013, Italy

Location

U.O. Neurologia IRCCS San Raffaele Pisana

Rome, Lazio, 00163, Italy

Location

IRCCS Centro Neurolesi "Bonino Pulejo"

Messina, Sicily, 98124, Italy

Location

MeSH Terms

Conditions

Parkinson DiseasePsychotic Disorders

Interventions

metylperon

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
H. Lundbeck A/S
Organization
H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 29, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

June 17, 2011

Results First Posted

June 17, 2011

Record last verified: 2011-05

Locations

US(10)IN(8)IT(3)