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Trial record 58 of 66 for:    strength | ( Map: India )

Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125138
Recruitment Status : Completed
First Posted : July 29, 2005
Results First Posted : June 17, 2011
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
Lundbeck LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson's Disease
Psychotic Disorders
Interventions Drug: Melperone HCl
Drug: Placebo
Enrollment 90
Recruitment Details Subjects were recruited from July 2005 to December 2007. Investigator sites were hospitals, research centers, movement disorder centers, and neurology centers.
Pre-assignment Details Subjects entered the Screening/Washout Period (for all previous antipsychotic medications) for a maximum of 2 weeks. On Day 1, the criteria for Randomization were reviewed by the investigator and psychiatric, motor function, and safety assessments were performed. Subjects who qualified on Day 1 were randomized to receive melperone or placebo.
Arm/Group Title Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Hide Arm/Group Description 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS Syrup with 0.3 mg/mL quinine orally QHS
Period Title: Overall Study
Started 15 20 [1] 25 30
Completed 12 17 21 25
Not Completed 3 3 4 5
Reason Not Completed
Adverse Event             1             0             3             2
Withdrawal by Subject             2             3             1             1
Lack of Efficacy             0             0             0             1
Sponsor decision-pt moved to assist care             0             0             0             1
[1]
One subject requested withdrawal prior to treatment; data for the subject are excluded from results.
Arm/Group Title Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo Total
Hide Arm/Group Description 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS Syrup with 0.3 mg/mL quinine orally QHS Total of all reporting groups
Overall Number of Baseline Participants 15 19 25 30 89
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 19 participants 25 participants 30 participants 89 participants
68.9  (6.2) 69.0  (11.8) 67.4  (11.2) 68.5  (9.6) 68.4  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 19 participants 25 participants 30 participants 89 participants
Female
4
  26.7%
6
  31.6%
10
  40.0%
10
  33.3%
30
  33.7%
Male
11
  73.3%
13
  68.4%
15
  60.0%
20
  66.7%
59
  66.3%
1.Primary Outcome
Title Patient Evaluation of Symptoms of Psychosis.
Hide Description 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.
Time Frame 6 weeks (from Baseline to end of Maintenance Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.
Arm/Group Title Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Hide Arm/Group Description:
5 mg/mL Melperone syrup orally QHS
5 mg/mL Melperone syrup orally QHS
5 mg/mL Melperone syrup orally QHS
Syrup with 0.3 mg/mL quinine orally QHS
Overall Number of Participants Analyzed 12 17 21 25
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-9.8  (4.4) -12.9  (4.0) -9.7  (3.5) -10.0  (3.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Melperone HCl - 20 mg, Placebo
Comments The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5177
Comments One-sided pairwise p-value comparing each active treatment to placebo.
Method ANCOVA
Comments One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate
Method of Estimation Estimation Parameter Difference of LS Mean
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-6.3 to 6.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Melperone HCl - 40 mg, Placebo
Comments The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1519
Comments One-sided pairwise p-value comparing each active treatment to placebo.
Method ANCOVA
Comments One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.
Method of Estimation Estimation Parameter Difference of LS mean
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-8.5 to 2.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Melperone HCl - 60 mg, Placebo
Comments The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5406
Comments One-sided pairwise p-value comparing each active treatment to placebo.
Method ANCOVA
Comments One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.
Method of Estimation Estimation Parameter Difference of LS mean
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-5.2 to 5.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Investigator/Caregiver Evaluations of Motor Function
Hide Description The change in the motor section of the Unified Parkinson’s Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.
Time Frame 6 weeks (from Baseline to end of Maintenance Period)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat [MITT] population) were included in the analysis of efficacy.
Arm/Group Title Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Hide Arm/Group Description:
5 mg/mL Melperone syrup orally QHS
5 mg/mL Melperone syrup orally QHS
5 mg/mL Melperone syrup orally QHS
Syrup with 0.3 mg/mL quinine orally QHS
Overall Number of Participants Analyzed 12 17 21 25
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.7  (8.5) 1.8  (12.9) 0.9  (11.1) 0.5  (6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Melperone HCl - 20 mg, Melperone HCl - 40 mg, Melperone HCl - 60 mg, Placebo
Comments Only subjects with both a baseline and a post-baseline value are included.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9212
Comments Overall p-value using a one-way ANCOVA.
Method ANCOVA
Comments One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.
Time Frame AEs were recorded from administration of study drug on Day 1 to 30 days after the last dose of study drug. SAEs were collected from when the informed consent and HIPAA (US sites only) were signed to 30 days after the last dose of study drug.
Adverse Event Reporting Description All AEs, expected or unexpected, that occurred during the study, whether observed by the investigator or by the subject and whether or not these events were thought to be related to study drug, were reported and followed-up until resolved or until the investigator judged that further follow-up was not necessary.
 
Arm/Group Title Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Hide Arm/Group Description 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS 5 mg/mL Melperone syrup orally QHS Syrup with 0.3 mg/mL quinine orally QHS
All-Cause Mortality
Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   2/19 (10.53%)   2/25 (8.00%)   0/30 (0.00%) 
Cardiac disorders         
Angina pectoris  1  0/15 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Viral infection  1  0/15 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/30 (0.00%) 
Investigations         
Muscle strain  1  0/15 (0.00%)  1/19 (5.26%)  0/25 (0.00%)  0/30 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm malignant  1  1/15 (6.67%)  0/19 (0.00%)  0/25 (0.00%)  0/30 (0.00%) 
Nervous system disorders         
Parkinson's Disease  1  1/15 (6.67%)  0/19 (0.00%)  1/25 (4.00%)  0/30 (0.00%) 
Syncope vasovagal  1  1/15 (6.67%)  0/19 (0.00%)  0/25 (0.00%)  0/30 (0.00%) 
Skin and subcutaneous tissue disorders         
Benign prostatic hyperplasia  1  0/15 (0.00%)  0/19 (0.00%)  1/25 (4.00%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Melperone HCl - 20 mg Melperone HCl - 40 mg Melperone HCl - 60 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/15 (40.00%)   8/19 (42.11%)   10/25 (40.00%)   6/30 (20.00%) 
Infections and infestations         
Urinary tract infection  1  2/15 (13.33%)  2/19 (10.53%)  0/25 (0.00%)  1/30 (3.33%) 
Nervous system disorders         
Parkinson's Disease  1  2/15 (13.33%)  4/19 (21.05%)  5/25 (20.00%)  4/30 (13.33%) 
Somnolence  1  2/15 (13.33%)  3/19 (15.79%)  6/25 (24.00%)  2/30 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI could publish the results of the Study after the earlier of (a) the cooperative publication of the data, or (b) 18 months after Sponsor’s final evaluation of all data; the PI will submit for review and approval any proposed abstracts and manuscripts at least 45 days prior to submission. The Institution and PI agree to delete any information the Sponsor deems confidential or proprietary; if the parties disagree, then they agree to meet prior to submission to discuss and resolve the issues.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: Lundbeck Inc.
ClinicalTrials.gov Identifier: NCT00125138     History of Changes
Other Study ID Numbers: 13104A
OV1003 ( Other Identifier: Former study ID )
First Submitted: July 27, 2005
First Posted: July 29, 2005
Results First Submitted: April 11, 2011
Results First Posted: June 17, 2011
Last Update Posted: June 17, 2011