Trial Outcomes & Findings for Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease (NCT NCT00125138)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

6 weeks (from Baseline to end of Maintenance Period)

Results posted on

2011-06-17

Participant Flow

Subjects were recruited from July 2005 to December 2007. Investigator sites were hospitals, research centers, movement disorder centers, and neurology centers.

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.

Participant milestones

Participant milestones
Measure	Melperone HCl - 20 mg 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg 5 mg/mL Melperone syrup orally QHS	Placebo Syrup with 0.3 mg/mL quinine orally QHS
Overall Study STARTED	15	20	25	30
Overall Study COMPLETED	12	17	21	25
Overall Study NOT COMPLETED	3	3	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Melperone HCl - 20 mg 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg 5 mg/mL Melperone syrup orally QHS	Placebo Syrup with 0.3 mg/mL quinine orally QHS
Overall Study Adverse Event	1	0	3	2
Overall Study Withdrawal by Subject	2	3	1	1
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Sponsor decision-pt moved to assist care	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melperone HCl - 20 mg n=15 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg n=19 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg n=25 Participants 5 mg/mL Melperone syrup orally QHS	Placebo n=30 Participants Syrup with 0.3 mg/mL quinine orally QHS	Total n=89 Participants Total of all reporting groups
Age Continuous	68.9 years STANDARD_DEVIATION 6.2 • n=5 Participants	69.0 years STANDARD_DEVIATION 11.8 • n=7 Participants	67.4 years STANDARD_DEVIATION 11.2 • n=5 Participants	68.5 years STANDARD_DEVIATION 9.6 • n=4 Participants	68.4 years STANDARD_DEVIATION 10.0 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	20 Participants n=4 Participants	59 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks (from Baseline to end of Maintenance Period)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Melperone HCl - 20 mg n=12 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg n=17 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg n=21 Participants 5 mg/mL Melperone syrup orally QHS	Placebo n=25 Participants Syrup with 0.3 mg/mL quinine orally QHS
Patient Evaluation of Symptoms of Psychosis.	-9.8 Scores on a scale Standard Error 4.4	-12.9 Scores on a scale Standard Error 4.0	-9.7 Scores on a scale Standard Error 3.5	-10.0 Scores on a scale Standard Error 3.7

SECONDARY outcome

Timeframe: 6 weeks (from Baseline to end of Maintenance Period)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Melperone HCl - 20 mg n=12 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg n=17 Participants 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg n=21 Participants 5 mg/mL Melperone syrup orally QHS	Placebo n=25 Participants Syrup with 0.3 mg/mL quinine orally QHS
Investigator/Caregiver Evaluations of Motor Function	0.7 Scores on a scale Standard Deviation 8.5	1.8 Scores on a scale Standard Deviation 12.9	0.9 Scores on a scale Standard Deviation 11.1	0.5 Scores on a scale Standard Deviation 6.4

Adverse Events

Melperone HCl - 20 mg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Melperone HCl - 40 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Melperone HCl - 60 mg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Melperone HCl - 20 mg n=15 participants at risk 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg n=19 participants at risk 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg n=25 participants at risk 5 mg/mL Melperone syrup orally QHS	Placebo n=30 participants at risk Syrup with 0.3 mg/mL quinine orally QHS
Nervous system disorders Parkinson's Disease	6.7% 1/15 • 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. 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.	0.00% 0/19 • 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. 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.	4.0% 1/25 • 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. 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.	0.00% 0/30 • 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. 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.
Nervous system disorders Syncope vasovagal	6.7% 1/15 • 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. 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.	0.00% 0/19 • 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. 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.	0.00% 0/25 • 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. 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.	0.00% 0/30 • 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. 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.
Cardiac disorders Angina pectoris	0.00% 0/15 • 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. 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.	5.3% 1/19 • 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. 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.	0.00% 0/25 • 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. 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.	0.00% 0/30 • 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. 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.
Infections and infestations Viral infection	0.00% 0/15 • 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. 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.	5.3% 1/19 • 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. 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.	0.00% 0/25 • 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. 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.	0.00% 0/30 • 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. 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.
Investigations Muscle strain	0.00% 0/15 • 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. 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.	5.3% 1/19 • 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. 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.	0.00% 0/25 • 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. 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.	0.00% 0/30 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	6.7% 1/15 • 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. 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.	0.00% 0/19 • 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. 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.	0.00% 0/25 • 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. 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.	0.00% 0/30 • 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. 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.
Skin and subcutaneous tissue disorders Benign prostatic hyperplasia	0.00% 0/15 • 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. 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.	0.00% 0/19 • 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. 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.	4.0% 1/25 • 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. 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.	0.00% 0/30 • 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. 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.

Other adverse events

Other adverse events
Measure	Melperone HCl - 20 mg n=15 participants at risk 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 40 mg n=19 participants at risk 5 mg/mL Melperone syrup orally QHS	Melperone HCl - 60 mg n=25 participants at risk 5 mg/mL Melperone syrup orally QHS	Placebo n=30 participants at risk Syrup with 0.3 mg/mL quinine orally QHS
Infections and infestations Urinary tract infection	13.3% 2/15 • 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. 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.	10.5% 2/19 • 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. 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.	0.00% 0/25 • 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. 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.	3.3% 1/30 • 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. 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.
Nervous system disorders Parkinson's Disease	13.3% 2/15 • 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. 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.	21.1% 4/19 • 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. 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.	20.0% 5/25 • 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. 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.	13.3% 4/30 • 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. 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.
Nervous system disorders Somnolence	13.3% 2/15 • 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. 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.	15.8% 3/19 • 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. 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.	24.0% 6/25 • 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. 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.	6.7% 2/30 • 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. 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.

Additional Information

H. Lundbeck A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER