- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361242
24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion (PLEODIAL-II)
February 12, 2016 updated by: Pharnext SA
24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion
PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.
Study Overview
Detailed Description
Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France
- CMRR
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Mild Alzheimer's Disease patient who was included in PLEODIAL-I study
- Mini Mental State Examination (MMSE) score greater or equal to 20
Main Exclusion Criteria:
- Patient who was not compliant with the previous PLEODIAL-I study protocol
- Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PXT00864 Dose 1
1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks.
|
PXT00864 is a fixed-dose combination of baclofen and acamprosate
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Experimental: PXT00864 Dose 2
1 orange capsule containing 1 mg of acamprosate and 1 white capsule containing 15 mg of baclofen are taken orally b.i.d during 24 weeks.
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PXT00864 is a fixed-dose combination of baclofen and acamprosate
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Experimental: PXT00864 Dose 3
1 orange capsule containing 20 mg of acamprosate and 1 white capsule containing 12 mg of baclofen are taken orally b.i.d during 24 weeks.
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PXT00864 is a fixed-dose combination of baclofen and acamprosate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
Time Frame: V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)
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Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment
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V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)
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Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: throughout the 24-week study period
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throughout the 24-week study period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 6, 2015
First Submitted That Met QC Criteria
February 6, 2015
First Posted (Estimate)
February 11, 2015
Study Record Updates
Last Update Posted (Estimate)
February 15, 2016
Last Update Submitted That Met QC Criteria
February 12, 2016
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLN-PXT00864-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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