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    Summary
    EudraCT Number:2022-001563-26
    Sponsor's Protocol Code Number:NCT05355337
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-08-05
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2022-001563-26
    A.3Full title of the trial
    Pramipexole for Anhedonic Depression (PRIME-PRAXOL)
    Tilläggsbehandling med Pramipexol mot Anhedonisymptom vid Depression - PRIME-PRAXOL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Drug treatment with Pramipexole for lack of interest and motivation in depression.
    Läkemedelsbehandling med pramipexol vid symptomen bristande intresse och nedsatt motivation vid depression.
    A.3.2Name or abbreviated title of the trial where available
    PRIME-PRAXOL
    A.4.1Sponsor's protocol code numberNCT05355337
    A.5.4Other Identifiers
    Name:Swedish Ethics Review AuthorityNumber:2021-06876-01
    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 SponsorRegion Skåne
    B.1.3.4CountrySweden
    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 supportVetenskapsrådet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportALF
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportKungliga fysiografiska sällskapet
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportOlle Engkvists Stiftelse
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportCraafordstiftelsen
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEllen och Henrik Sjöbrings Minnesfond
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportO.M. Perssons Minnesfond
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportHjärnfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch associate
    B.5.2Functional name of contact pointJesper Lindahl
    B.5.3 Address:
    B.5.3.1Street AddressBaravägen 1
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22185
    B.5.3.4CountrySweden
    B.5.4Telephone number0046046174457
    B.5.6E-mailjesper.lindahl@med.lu.se
    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 Pramipexol Stada prolonged-release tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSTADA Arzneimittel AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePramipexol Stada prolonged-release tablets 0,26 mg, 0,52 mg, 1,05 mg and 2,1 mg
    D.3.4Pharmaceutical form Prolonged-release tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    The effect of nine weeks of treatment with the dopamine agonist Pramipexole in patients with depression with clinically significant anhedonia will be evaluated with symptom rating scales, blood and cerebrospinal fluid samples, neuroimaging, and neuropsychological testing. Thus, this study focuses on patients with substantial anhedonia and these patients are identified through validated assessment scales.
    Behandlingseffekten av nio veckors behandling med dopaminagonisten pramipexol för patienter med depression med kliniskt signifikant anhedoni kommer att utvärderas med symptomskattningar, blod- och likvorprover, neuroimaging och neuropsykologisk testning. Studien riktar sig alltså till patienter med uttalad anhedoni och dessa patienter identifieras via vedertagna skattningsskalor.
    E.1.1.1Medical condition in easily understood language
    The patients treated in this study must have an ongoing depression with clearly lowered interest and decreased motivation (i.e. strong anhedonia).
    Patienterna som behandlas i denna studie ska ha en pågående depression med tydligt sänkt intresse och minskad motivation (d.v.s. uttalad anhedoni).
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002511
    E.1.2Term Anhedonia
    E.1.2System Organ Class 10037175 - Psychiatric 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 research question is: Will treatment with Pramipexole at the highest possible dosage (without intolerable side effects, max 3.15 mg base) reduce anhedonia symptoms over a nine-week period compared to placebo?

    For complete information, please see study protocol.
    Den primära frågeställningen är: Kommer behandling med pramipexol i högsta möjliga dosering (utan intolererbara biverkningar, max 3,15 mg bas) minska anhedonisymptom under en nioveckorsperiod jämfört med placebo-behandling?

    För fullständig information, var god se studieprotokoll.
    E.2.2Secondary objectives of the trial
    1. Will treatment with Pramipexole in the highest possible dosage reduce depression symptoms over a nine-week period?
    2. Will treatment with Pramipexole at the highest possible dosage increase daily physical activity, reduce stress and improve sleep quality recorded with activity monitors over a nine-week period?
    3. Will treatment with Pramipexole in the highest possible dosage reduce psychological symptoms as measured by the rating scales DARS, MADRS, AES, ISI, BBQ and GAD-7 during a nine-week period?
    4. Will treatment with pramipexole in the highest possible dosage increase activity in the ventral striatum in connection with the MID test in fMRI?
    5. Can inflammation and dopamine markers in blood and CSF, activity and connectivity in ventral striatum in MID task predict treatment response to pramipexole?
    6. Is pramipexole an effective treatment for anhedonic depression after 6 months of follow-up?
    7. Is cognitive function profile related to state or scar/trait?
    1. Kommer behandling med pramipexol i högsta möjliga dosering minska depressionssymptom under en nioveckorsperiod?
    2. Kommer behandling med pramipexol i högsta möjliga dosering öka daglig fysisk aktivitet, minska stress och förbättra sömnkvalitet registrerat med aktivitetsmätare under en nioveckorsperiod?
    3. Kommer behandling med pramipexol i högsta möjliga dosering minska psykiska symptom mätt med skattningsskalorna DARS, MADRS, AES, ISI, BBQ och GAD-7 under en nioveckorsperiod?
    4. Kommer behandling med pramipexol i högsta möjliga dosering öka aktiviteten i ventrala striatum i samband med MID-testet vid fMRI?
    5. Kan inflammations- och dopaminomsättningsmarkörer i blod och CSF, aktivitet och konnektivitet i ventrala striatum vid MID-task förutsäga behandlingssvar av pramipexol?
    6. Är pramipexol en effektiv behandling vid anhedonisk depression efter 6 månaders uppföljning?
    7. Är kognitiv funktionsprofil relaterad till state eller scar/trait?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The main study is a randomized controlled trial with two arms (pramipexole or placebo). All included research subjects will also be asked about participation in the sub studies for fMRI examination, lumbar puncture and neuropsychological testing respectively (before and after 9 weeks of treatment with pramipexole) and whether they want to participate in a follow-up that extends another 6 months after the end of the RCT (separate study: LONG-PRAXOL). There are thus three sub study parts: (1) fMRI, (2) lumbar puncture with cerebrospinal fluid sampling and (3) neuropsychological testing.
    Huvudstudien utgörs av en randomiserad kontrollerad studie med två armar (pramipexol eller placebo). Alla inkluderade forskningspersoner kommer även tillfrågas om deltagande i substudie för fMRI-undersökning, lumbalpunktion och neuropsykologisk testning (före och efter 9 veckors behandling med pramipexol) samt om de vill delta i en uppföljning som sträcker sig ytterligare 6 månader efter avslut av RCT (separat studie: LONG-PRAXOL). Det finns således tre substudie-moment: (1) fMRI, (2) lumbalpunktion med likvorprov och (3) neuropsykologisk testning.
    E.3Principal inclusion criteria
    1. Age ≥18 years ≤75 years.
    2. Diagnosis of: unipolar depressive episode or bipolar disorder in depressive phase, or dysthymia.
    3. Anhedonia symptoms: 3 or 4 points on ≥ 3 items of the Snaith-Hamilton Pleasure Scale (SHAPS-C). This has been adopted in previous studies as a definition of "clinically significant anhedonia".
    4. Ongoing treatment with at least one antidepressant or mood stabilizing medication ≥ 4 weeks. Has tried an antidepressant at a therapeutic dose but not achieved remission (refractory stage 1 depression).
    5. The research subject has given informed consent to participate in the study.
    1. Ålder ≥18 år ≤75 år.
    2. Diagnos av unipolär depressiv episod, bipolär sjukdom i depressiv fas, eller dystymi.
    3. Anhedonisymptom; 3 eller 4 poäng på ≥ 3 items på Snaith–Hamilton Pleasure Scale (SHAPS-C). Detta har i tidigare studier ansetts vara en definition av ”kliniskt signifikant anhedoni”.
    4. Har en pågående behandling av minst ett antidepressivt eller stämningsstabiliserande läkemedel ≥ 4 veckor. Man ska ha testat ett antidepressivt preparat i terapeutisk dos men ej uppnått remission (terapirefraktär depression steg 1).
    5. Forskningspersonen har gett informerat samtycke till att delta i studien.
    E.4Principal exclusion criteria
    1. Pregnancy, breastfeeding or planned pregnancy (if female).
    2. High suicide risk according to the overall clinical assessment of the research physician.
    3. Ongoing substance abuse (within 6 months).
    4. Diagnosis of current psychosis.
    5. Known diagnosis of Emotionally Unstable Personality Disorder.
    6. Treatment under LPT.
    7. History of, or strong clinical suspicion, impulse control disorder (including current binge-eating disorder) or a current ADHD diagnosis with hyperactivity.
    8. Diagnosis of intellectual disability, dementia, or other circumstance that makes it difficult to understand the meaning of participating in the trial and give informed consent.
    9. Diagnosis of renal failure (eGFR < 50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure NYHA Class II or higher).
    10. Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial.
    11. Ongoing ECT, ketamine or rTMS treatment, excluding maintenance ECT, ketamine or rTMS. (Maintenance treatment is defined as the use of ECT/ketamine/rTMS for a period exceeding 3 months after a series of ECT/ketamine/rTMS treatment in order to prevent the onset of a new episode).
    12. Other medical conditions, and other medical procedures, or other concomitant drug treatment (see section 14.5) which, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example, Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year, bariatric surgery with known influence on absorption of extended-release tablets in the gastrointestinal tract.
    13. Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.
    14. Participation in other treatment studies.
    15. Other reason, as assessed by the investigator, that prevents the research subject's participation, such as the risk that the research subject is unable to complete the trial (non-compliance).
    1. Pågående graviditet, amning eller planerad graviditet (om kvinna).
    2. Hög suicidrisk enligt forskningsläkarens samlade kliniska bedömning.
    3. Pågående Substansmissbruk (inom 6 månader).
    4. Diagnos av aktuell psykossjukdom.
    5. Känd diagnos av Emotionellt instabil personlighetsstörning.
    6. Behandling enligt LPT.
    7. Anamnes på, eller stark klinisk misstanke, om impulskontrollstörning (inklusive aktuell hetsätningsproblematik) eller en aktuell ADHD diagnos med hyperaktivitet.
    8. Diagnos i form av intellektuell funktionsnedsättning, demens, eller andra omständigheter som innebär en svårighet att förstå innebörden av att delta i studien och ge informerat samtycke.
    9. Diagnos av njursvikt (eGFR < 50 ml/min/1,73 m2 ) eller svår kardiovaskulär sjukdom (specifikt symptomgivande hjärtsvikt NYHA klass 2 eller högre)
    10. Nyligen påbörjad psykoterapi (inom 6 veckor) eller planering på att starta en sådan behandling under medverkan i studien.
    11. Pågående ECT-, ketamin- eller rTMS-behandling, undantaget underhålls-ECT, -ketamin eller -rTMS. (Underhållsbehandling definieras som att man under en period som överstiger 3 månader efter en indexserie av ECT/ketamin/rTMS använder ECT/ketamin/rTMS i syfte att förbygga insjuknande i en ny episod).
    12. Andra sjukdomstillstånd, andra pågående åtgärder eller annan samtidig läkemedelsbehandling (se avsnitt 14.5) som enligt prövarna kan påverka studiens utvärderbarhet eller tillstånd som ökar prövningens risk. Exempelvis Parkinsons sjukdom, leverinsufficiens, pågående cancersjukdom som ej gått i remission för över ett år sedan eller fetmakirurgi med känd påverkan av upptag av depottabletter i magtarmkanalen.
    13. Känd eller misstänkt allergi mot någon aktiv substans eller hjälpämne i läkemedelsprodukten som ingår i studien.
    14. Deltagande i andra behandlingsstudier.
    15. Annan orsak, bedömt av prövare, som förhindrar forskningspersonens deltagande, som till exempel risk att forskningsperson inte kan genomföra studien (bristfällig compliance).
    E.5 End points
    E.5.1Primary end point(s)
    Will treatment with pramipexole at the highest possible dose (without intolerable adverse reactions, max 3.15 mg base) reduce anhedonia symptoms over a nine-week period compared to placebo treatment?

    Primary variable 1: Total SHAPS-C scores at baseline, week 3, week 6 and week 9 (endpoint).
    Total-poäng SHAPS-C
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 3, week 6 and week 9 (endpoint).
    Overall end of trial 1 December 2026. 
    Baseline, vecka 3, vecka 6 och vecka 9 (endpoint)
    E.5.2Secondary end point(s)
    Secondary question 1: Will treatment with pramipexole at the highest possible dose (without intolerable adverse reactions, max 3.15 mg base) reduce depression symptoms over a nine-week period?

    Secondary variable 1: HDRS6 scores (subscale of HDRS-17) at baseline, week 3, week 6 and week 9 (endpoint).

    Secondary question 2: Will treatment with pramipexole at the highest possible dose (without intolerable adverse reactions, max 3.15 mg base) increase daily physical activity, reduce stress and improve sleep quality over a nine-week period?

    Secondary variables 2: Number of steps/day, movement pattern distribution over the day, walking distance, time spent in light, moderate and intense physical activity, resting heart rate, blood oxygen saturation, heart rate variability (stress scores), sleep latency (time to fall asleep), sleep awakening (how often you wake up during the night), wakefulness (time in minutes awake during a night), time in deep sleep, sleep efficiency (time asleep vs. total time in bed). All variables are measured using activity meters.

    Secondary question 3: Will treatment with pramipexole at the highest possible dose (without intolerable adverse reactions, max 3.15 mg base) reduce psychological symptoms and increase quality of life as measured by the DARS-SV-MOD, MADRS-S, Insomnia Severity Scale, AES, GAD-7 and Brunnsviken Brief Quality Life Scale (BBQ) over a nine-week period?

    Secondary variables 3: Total scores of DARS-SV-MOD, MADRS-S, Insomnia Severity Scale, AES, GAD-7 and BBQ.

    Secondary question 4: Will treatment with pramipexole at the highest possible dose (without intolerable adverse reactions, max 3.15 mg base) increase the activity of the ventral striatum in the context of the MID test at fMRI?

    Secondary variable 4: BOLD activity in the nucleus accumbens during MID task fMRI.

    Secondary question 5: Can inflammation and dopamine-turnover markers in blood and CSF and ventral striatum connectivity and activity during MID task predict treatment response of pramipexole? Can genetic variants linked to dopamine and inflammatory systems be linked to improved treatment response?

    Secondary variables 5: Biomarkers and genetic variants linked to inflammation and dopamine. BOLD activity in the nucleus accumbens during MID task fMRI and connectivity during diffusion tensor imaging.
    1: HDRS6-poäng (subskala till HDRS-17)
    2: Antal steg/dag, rörelsemönstrets fördelning över dygnet, promenadsträcka, tid spenderad för lätt, måttlig och intensiv fysisk aktivitet, vilopuls, syremättnad i blod, hjärtfrekvens-variabilitet (stress scores), sömnlatens (tid att falla i sömn), sömnuppvaknande (hur ofta man vaknar upp på natten), vakenhet (tid i minuter vaken under en natt), tid i djupsömn, sömneffektivitet (tid i sömn av totala tiden i sängen). Alla variabler mäts med hjälp av aktivitetsmätare som är CE-märkt.
    3: Total-poäng av DARS-SV-MOD, MADRS-S, Insomnia Severity Scale, AES, GAD-7 och BBQ
    4: BOLD-aktivitet i nucleus accumbens vid MID-task fMRI.
    5: Biomarkörer och genetiska varianter kopplade till inflammation, cellulär hälsa (inklusive neurodegeneration), cellulär stress och metabolism, tillväxtfaktorer och monoaminomsättning. BOLD-aktivitet i nucleus accumbens vid MID-task fMRI samt konnektivitet vid diffusionstensoravbildning.
    6: SHAPS-C, HDRS-6 och DARS-SV-MOD
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline, week 3, week 6 and week 9 (endpoint).
    2. Continuously during the study.
    3. Baseline, week 3, week 6 and week 9 (endpoint).
    4 and 5: At baseline and week 9 (endpoint).
    6: After 6 months.
    1: Baseline, vecka 3, vecka 6 och vecka 9 (endpoint).
    2: Kontinuerligt under studien.
    3: Baseline, vecka 3, vecka 6 och vecka 9 (endpoint).
    4 och 5: Vid baseline samt vecka 9 (endpoint)
    6: Efter 6 månader
    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 Yes
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    Approved application regarding recruitment of 40 healthy volunteers as a separate comparator.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state120
    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)
    After the subject has ended the participation of the trial they will be asked whether they want to participate in a follow-up that extends another 6 months after the end of the RCT.
    Forskningspersonen kommer att tillfrågas om medverkan i en uppföljningsstudie under 6 månaders naturalistisk behandling med pramipexol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-03
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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