Trial document




drksid header

  DRKS00000756

Trial Description

start of 1:1-Block title

Title

A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson's disease administered once daily for 28 Weeks

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CONFIDENT-PD

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A 28 week study to test the clinical benefit of Cogane (PYM50028), compared with placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed primarily using the Unified Parkinson's Disease Rating Scale (UPDRS).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel group study investigating the efficacy, safety, tolerability and plasma concentration of PYM50028 at three dose levels when administered over 28 weeks. Subjects will take their medication at approximately the same time each day with a meal (e.g. breakfast or lunch). Subjects will be assessed at screening, baseline and regular intervals during the study, up to week 32. During these visits efficacy, safety and / or bioanalytical parameters will be assessed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000756
  •   2011/05/10
  •   2010/02/01
  •   no
  •   Approved
  •   231/10(A), Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2010-018534-44 
  •   NCT01060878  (ClinicalTrials.gov)
  •   4036561 
  •   P58/07CL/ST/09/02 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G20 -  Parkinson's disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Once daily oral administration of PYM50028, high dose
  •   Once daily oral administration of PYM50028, mid dose
  •   Once daily oral administration of PYM50028, low dose
  •   Once daily oral administration of Placebo
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Change in UPDRS (Unified Parkinson's Disease Rating Scale) parts II & III combined score between baseline and 28 weeks

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Change in SCOPA-COG (Scales for Outcomes of Parkinson's disease – Cognition) total score between baseline and 28 weeks
Change in PDQ-39 (Parkinson's Disease Questionnaire) scores between baseline and 28 weeks
Change in ESS (Epworth Sleepiness Scale) total score between baseline and 28 weeks
Change in NMSS (Non-Motor Symptoms Scale) scores between baseline and 28 weeks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   United States
  •   Canada
  •   France
  •   Hungary
  •   Romania
  •   Poland
  •   Czech Republic
  •   Serbia
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/05/09
  •   408
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Key inclusion criteria:

1) Confirmed diagnosis of early stage idiopathic PD within the 2 years prior to screening
2) Subjects who have not taken and / or are not currently receiving any PD treatment

Other inclusion criteria apply

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Key exclusion criteria:

1) female of child-bearing potential
2) history of neurosurgical procedures for PD
3) history of severe psychiatric illness

Other exclusion criteria apply

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Phytopharm plc
    • Lakeview House, 2 Lakeview Court, Ermine Business Park
    • PE29 6UA  Huntingdon
    • United Kingdom
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Phytopharm plc
    • Dr.  Nick  Meyers 
    • Lakeview House, 2 Lakeview Court, Ermine Business Park
    • PE29 6UA  Huntingdon
    • United Kingdom
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Phytopharm plc
    • Ms.  Joanna  Locker 
    • Lakeview House, 2 Lakeview Court, Ermine Business Park
    • PE29 6UA  Huntingdon
    • United Kingdom
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Phytopharm plc
    • Lakeview House, 2 Lakeview Court, Ermine Business Park
    • PE29 6UA  Huntingdon
    • United Kingdom
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/12/05
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.