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    Summary
    EudraCT Number:2009-017925-20
    Sponsor's Protocol Code Number:RR08/8789
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2009-017925-20
    A.3Full title of the trial
    Does Cocareldopa treatment in combination with routine NHS occupational and physical therapy, delivered early after stroke within a stroke service, improve functional recovery including walking and arm function?
    A.3.2Name or abbreviated title of the trial where available
    DARS - Dopamine Augmented Rehabilitation in Stroke
    A.4.1Sponsor's protocol code numberRR08/8789
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN99643613
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Leeds
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SinemetSinemet Plus
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSinemet & Sinemet Plus (Co-careldopa)
    D.3.2Product code PL 0025/0150 & PL 0025/0226
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarbidopa
    D.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameSinemet
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameSinemet
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarbidopa
    D.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameSinemet Plus
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNot applicable
    D.3.9.3Other descriptive nameSinemet Plus
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischaemic or Haemorrhagic Stroke
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019016
    E.1.2Term Haemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare the proportion of patients in both treatment groups walking at 8 weeks post randomisation (as measured by a score of 7 or higher and who also answer 'yes' to item number 7 on the Rivermead Mobility Index).
    E.2.2Secondary objectives of the trial
    The Secondary Objectives are: Impact on physical functioning and mood at 8 weeks, 6 months and 12 months •To compare the proportion of patients who are walking at 6 and 12 months post-randomisation in the two groups, as measured by a score of 7 or higher and who also answer 'yes' to item number 7 on the Rivermead Mobility Index •To compare activities of daily living and dependency (Rivermead Mobility Index (continuous), Barthel Index, Modified Rankin Scale, Nottingham Extended Activities of Daily Living Scale, ABILHAND) between groups. •To compare psychological distress / mood between the two groups (General Health Questionnaire 12) •To compare carer burden between groups using the Caregiver Burden Scale •To investigate cost effectiveness of Co-careldopa and conventional rehabilitation treatments (EQ-5D to quantify care costs) Investigate potential moderators and mediators of effect at 8 weeks, 6 months and 12 months •To investigate whether baseline patient clinical charac
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting all of the following criteria on day of screening are eligible for trial entry. If not, the patient’s condition may change during 5 to 42 days post stroke and the patient must be reviewed during this period to assess eligibility: 1. New or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke within 5 to 42 days prior to randomisation. 2. Cannot walk 10 metres or more indoors independently (i.e. without use of physical assistance) 3. Professionally scored Rivermead Mobility Index score of <7. 4. Expected to need rehabilitation treatment 5. Aged 18 years or above 6. Able to give informed consent 7. Able to access continuity of rehabilitation treatment following discharge from hospital. This can be through early supported discharge scheme or hospital / community therapy according to local practice. It is important that continuity of rehabilitation is available within 5 days following discharge. 8. Expected to be able to comply with treatment schedule (e.g. swallow whole tablets)1 9. Expected to be in hospital for at least their first two doses trial medication 1Inclusion criterion numbers 6, 8 and other co-morbidities should be monitored up to 42 days post stroke as patients initially not meeting the eligibility criteria might improve and therefore meet the eligibility criteria within the 42 day post stroke period.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria are not eligible for trial entry: 1. Not expected to survive for 2 months following stroke 2. Diagnosis of Parkinson’s disease, severe medical or surgical illness, severe psychosis 3. Known hypersensitivity or contraindications to Co-careldopa2 4. Symptomatic orthostatic hypotension 5. Needed physical assistance of at least one person to walk prior to stroke due to pre-existing co-morbidities (e.g. heart failure, osteoarthritis) 6. Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 1 month after treatment has finished 7. Patients currently participating in other interventional drug or treatment therapy trials* 8. Could not walk 10 metres or more indoors prior to their stroke (may have used a walking aid if necessary, but required no physical assistance). In this context physical assistance means help from one or more persons *Enrollment of a trial participant in another trial will not necessarily exclude a patient from participating in the DARS trial. Potential trials for co-enrollment with DARS are considered by the Chief Investigator and Trial Management team with regards to: 1. It has been agreed with the Chief Investigator of the relevant studies. 2. It does not confound the results of DARS 3. It does not overburden the patient, 4. Attribution of causality to adverse events is not compromised 5. There are no potential interactions Contact the CTRU for confirmation of trials where co-enrollment is permitted. An update of trials where co-enrolment is agreed will be also reported in the trial newsletter. 2Please refer to the trial supplied Summary of Product Characteristics (SmPC).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ability to walk independently at 8 weeks defined by a score of 7 or more and answer 'yes' to item 7 on the Rivermead Mobility Index.
    E.5.2Secondary end point(s)
    PATIENT ENDPOINTS AT 8 WEEKS, 6 AND 12 MONTHS • Independent walking ability at 6 & 12 months (corresponding to RMI item 7 and RMI ≥ 7) • Rivermead Mobility Index (analysed as a continuous measure) • Barthel Index • ABILHAND • Nottingham Extended Activities of Daily Living Scale • GHQ-12 • EQ-5D • Modified Rankin scale CAREGIVER ENDPOINTS AT 8 WEEKS, 6 & 12 MONTHS • Caregiver Burden Scale • EQ-5D QUALITATIVE FOLLOW UP AT 8 WEEKS • Patient and Therapist perspective regarding use of IMP with rehabilitation treatment CLINICAL FOLLOW UP DATA AT 8 WEEKS • Treatment data (rehabilitation and drug compliance) • Concurrent medication
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the date of the last patient's treatment visit plus 30 days. Long term follow up for purposes of the Main REC and Research governance is one month after the last patient's last trial follow up visit which is the non interventional phase of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state572
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 572
    F.4.2.2In the whole clinical trial 572
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention phase (i.e. treatment with Co-careldopa) is scheduled to last for a maximum of 6 weeks. Thereafter, patients will continue to receive their usual post stroke occupational and physical therapy as decided by their GP or treating care team. The final interview with the researcher will take place approximately 12 months after randomisation. There are no arrangements in place for continued provision of the intervention for the participants once the research has finished
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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