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24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion (PLEODIAL-II)

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: NCT02361242
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
Ascopharm Groupe Novasco
Information provided by (Responsible Party):
Pharnext SA

Tracking Information
First Submitted Date  ICMJE February 6, 2015
First Posted Date  ICMJE February 11, 2015
Last Update Posted Date February 15, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
  • 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) ]
    Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: throughout the 24-week study period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion
Official Title  ICMJE 24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate
Study Arms  ICMJE
  • 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.
    Intervention: Drug: PXT00864
  • 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.
    Intervention: Drug: PXT00864
  • 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.
    Intervention: Drug: PXT00864
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)		 45
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2015)		 37
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02361242
Other Study ID Numbers  ICMJE CLN-PXT00864-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pharnext SA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pharnext SA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ascopharm Groupe Novasco
Investigators  ICMJE
Principal Investigator: Jean-Marc Orgogozo, MD Hospital Pellegrin, Bordeaux, France
PRS Account Pharnext SA
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP