Clinical trial • Phase III • Neurology
carbidopa, levodopa for Parkinson's disease
Phase III trial of carbidopa, levodopa for Parkinson's disease.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Parkinson's disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-03-2024
- First CTIS Authorization Date
- 17-05-2024
Trial design
Randomised, open-label, test group (group a): active nd0612 infusion (continuous subcutaneous nd0612 infusion) + placebo ir-ld/cd (white) + active ir-ld/cd (grey). control group (group b): active ir-ld/cd (oral immediate-release levodopa/carbidopa; ir-ld/cd 100/25 mg tablets with regimen adjusted per investigator, inclusion requires at least 4 doses/day and ≥400 mg/day levodopa or equivalent) + placebo infusion + placebo ir-ld/cd (grey). Phase III trial across 31 sites in Austria, Czechia, Italy and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test Group (Group A): Active ND0612 infusion (continuous subcutaneous ND0612 infusion) + placebo IR-LD/CD (white) + active IR-LD/CD (grey). Control Group (Group B): Active IR-LD/CD (oral immediate-release levodopa/carbidopa; IR-LD/CD 100/25 mg tablets with regimen adjusted per investigator, inclusion requires at least 4 doses/day and ≥400 mg/day levodopa or equivalent) + placebo infusion + placebo IR-LD/CD (grey).
- Target Sample Size
- 225
- Trial Duration For Participant
- 224
Eligibility
Recruits 225 Vulnerable population selected. Participants must sign an IRB/EC-approved informed consent form (ICF); a named study partner must also sign the ICF. The protocol requires MMSE ≥ 24 and uses study partners for participant support/diary completion, indicating procedures for participants who may need assistance..
- Pregnancy Exclusion
- All female subjects must be non-lactating and not pregnant and have a negative urine pregnancy test at Screening and at Enrollment (IR D1/ V2).
- Vulnerable Population
- Vulnerable population selected. Participants must sign an IRB/EC-approved informed consent form (ICF); a named study partner must also sign the ICF. The protocol requires MMSE ≥ 24 and uses study partners for participant support/diary completion, indicating procedures for participants who may need assistance.
Inclusion criteria
- {"criterion_text":"- Male and female subjects with PD of any race at least 30 years of age who sign an Institutional Review Board/Ethics Committee–approved informed consent form (ICF).\n- Subjects and/or study partners must demonstrate ability to keep accurate diary entries of PD symptoms (\"ON/OFF\" diaries) with at least 75% concordance with the Blinded Efficacy Rater by the end of the diary training session during the Screening Period, including at least 1 \"OFF\" assessment..\n- Mini Mental State Examination (MMSE) score ≥ 24.\n- Approval for entry into the study by an independent EAC.\n- Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation); postmenopausal (defined as cessation of menses for at least 1 year); or willing to practice a highly effective method of contraception. All female subjects must be non-lactating and not pregnant and have a negative urine pregnancy test at Screening and at Enrollment (IR D1/ V2). Female subjects of childbearing potential must practice a highly effective method of contraception (such methods include combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation: oral / intravaginal; transdermal / progestogen-only hormonal contraception associated with inhibition of ovulation: oral / injectable; implantable / intrauterine device [IUD] / intrauterine hormone-releasing system [IUS]/ bilateral tubal occlusion / vasectomized partner/ sexual abstinence) from 1 month before Enrollment (IR D1/V2) until 1 month after the last dose of study treatment. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above.\n- Subjects must have a named study partner that signed the ICF.\n- Willingness and ability to comply with study requirements.\n- Parkinson's disease diagnosis consistent with the UK Brain Bank Criteria.\n- Modified Hoehn and Yahr scale in \"ON\" stage ≤ 3.\n- Subjects must experience motor fluctuations and experience an average of at least 2.5 hours daily (with a minimum of 2 hours every day) in the \"OFF\" state during the waking hours as confirmed by an adequately completed \"ON/OFF\" diary over 3 days.\n- Subject treatment should be at least 4 doses/day of LD/DDI (or at least 3 doses/day of extended release LD/DDI, e.g., Rytary) and at least 400 mg/day of LD, or equivalent according to the conversion table, and, according to the Investigator's judgement, the subject experiences motor fluctuations that cannot be further improved by adjusting anti-PD medications.\n- Subjects and/or study partners have no impediment that may prevent them from operating the pump system."}
Exclusion criteria
- {"criterion_text":"- Atypical or secondary Parkinsonism.\n- Use of non-selective monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid, tranylcypromine) within 4 weeks before enrollment.\n- Subjects with severe disabling dyskinesias, based on Investigator's discretion.\n- Current or previous diagnosis of Dopamine Dysregulation Syndrome.\n- Subjects who answered \"yes\" to questions 4 or 5 of the C-SSRS within the last 5 years.\n- Use of subcutaneous (SC) apomorphine injections, sublingual apomorphine, or inhaled LD within 4 weeks before the enrollment.\n- Concomitant therapy or within 28 days before enrollment with: metoclopramide, reserpine, methylphenidate, or amphetamines, well as neuroleptics; exception in case of Quetiapine and Pimavanserin use: (1) allowed only in case it had been used for a period of at least 3 months before enrollment, (2) subject is on stable therapy for at least 3 months (3) underlying psychosis to be under control and anticipating no changes to the dosage of the medication throughout the study.\n- Subjects who have previously undergone treatment for PD with a surgical intervention (e.g., pallidotomy, thalamotomy, transplantation, deep brain stimulation procedures, gene therapy), Duodopa®/Duopa®, or continuous dopaminergic or apomorphine infusion. Subjects who have discontinued Duodopa®/Duopa® treatment at least 6 months before enrollment and have undergone stoma closure surgery at least 6 months before enrollment, may be included in this study. Subjects who are planning to undergo treatment for PD with a surgical intervention will be enrolled at the Investigator's discretion.\n- Subjects with a history of alcohol or substance abuse within the past 12 months.\n- Subjects who do not have sufficient SC tissue for SC infusion treatment.\n- Subjects who have previously participated in studies ND0612H-006 and/or ND0612H-012.\n- Use of monoamine-depleting agents (e.g., reserpine, tetrabenazine, deutetrabenazine, valbenazine, xenazine) within 4 weeks before enrollment.\n- Subjects who have taken experimental medications within 30 days before enrollment.\n- Known allergy to the study drug or placebo or any of their excipients.\n- Impulse control disorder within the past 2 years, if considered clinically significant by the investigator.\n- Acute psychosis or troublesome hallucinations in the past 6 months.\n- Subjects with clinically significant or unstable medical, surgical, or psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or the EAC, represents a safety risk, makes the subject unsuitable for study entry, or potentially unable to complete all aspects of the study.\n- History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of different lesions (e.g., sunburn, acne, scar tissue, tattoo, open wound, branding, or pigmentation) that, in the Investigator's opinion, would interfere with the infusion of the study drug or could interfere with study assessments.\n- Clinically significant ECG abnormalities.\n- Renal or liver dysfunction that may alter drug metabolism including Screening Visit serum levels of creatinine > 1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal, and total bilirubin > 2.5 mg/dL.\n- Any malignancy in the 5 years before enrollment, except basal cell carcinoma of the skin, squamous cell carcinoma in situ, or cervical carcinoma in situ that have been successfully treated.\n- Subjects with narrow angle glaucoma."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the change from Baseline to the end of the DBDD Maintenance Period in the mean daily \"ON\" time without troublesome dyskinesia adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's \"ON/OFF\" diary assessments on the 3 consecutive days before the visit.","definition_or_measurement_approach":"Change from Baseline to end of DBDD Maintenance Period in mean daily \"ON\" time without troublesome dyskinesia, adjusted to subject's waking hours and normalized to 16 waking hours, measured using subject-completed \"ON/OFF\" diary assessments over the 3 consecutive days before the visit."}
Secondary endpoints
- {"endpoint_text":"- The key secondary efficacy endpoint is the change from Baseline to the end of the DBDD Maintenance Period (DB W12) in the mean daily \"OFF\" time adjusted to subject's waking hours and normalized to 16 waking hours, based on subject's \"ON/OFF\" diary assessments on the 3 consecutive days before the visits.","definition_or_measurement_approach":"Change from Baseline to end of DBDD Maintenance Period (DB W12) in mean daily \"OFF\" time adjusted to subject's waking hours and normalized to 16 waking hours, measured using subject-completed \"ON/OFF\" diary assessments over the 3 consecutive days before the visits."}
Recruitment
- Planned Sample Size
- 225
- Recruitment Window Months
- 86
- Consent Approach
- Participants provide written informed consent using an IRB/EC-approved informed consent form (ICF). A named study partner must also sign the ICF. Multiple language versions of the ICF/SIS are provided (examples in the documents include English, French, Spanish, Portuguese, Italian, Polish, Slovak, Dutch), and consent processes follow local IRB/EC approval.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 156
Austria
- Latest Decision Or Authorization Date
- 22-05-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- University Hospital for Neurology
- Principal Investigator Name
- Werner Poewe
- Principal Investigator Email
- werner.poewe@i-med.ac.at
- Contact Person Name
- Werner Poewe
- Contact Person Email
- werner.poewe@i-med.ac.at
Czechia
- Latest Decision Or Authorization Date
- 21-05-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Axon Clinical s.r.o.
- Principal Investigator Name
- Kateřina Zárubová
- Principal Investigator Email
- katzar@centrum.cz
- Contact Person Name
- Kateřina Zárubová
- Contact Person Email
- katzar@centrum.cz
Italy
- Latest Decision Or Authorization Date
- 18-06-2024
- Number Of Sites
- 7
- Number Of Participants
- 41
Sites
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Dipartimento di Scienze Mediche e Chirurgiche Avanzate (DAMSS) - Università degli studi della Campan
- Principal Investigator Name
- Alessandro Tessitore
- Principal Investigator Email
- alessandro.tessitore@unicampania.it
- Contact Person Name
- Alessandro Tessitore
- Contact Person Email
- alessandro.tessitore@unicampania.it
- Site Name
- Universita' Degli Studi G. D'annunzio Di Chieti
- Department Name
- Department of Neuroscience, Imaging and Medical Sciences
- Principal Investigator Name
- Astrid Thomas
- Principal Investigator Email
- athomas@unich.it
- Contact Person Name
- Astrid Thomas
- Contact Person Email
- athomas@unich.it
- Site Name
- Fondazione Santa Lucia IRCCS
- Department Name
- Laboratory of Neuropsychiatry - Department of Clinical and Behavioral Neurology
- Principal Investigator Name
- Clelia Pellicano
- Principal Investigator Email
- c.pellicano@hsantalucia.it
- Contact Person Name
- Clelia Pellicano
- Contact Person Email
- c.pellicano@hsantalucia.it
- Site Name
- Irccs San Raffaele Roma S.r.l. (Cassino)
- Department Name
- San Raffaele Cassino - Parkinson Disease Center
- Principal Investigator Name
- Maria Francesca De Pandis
- Principal Investigator Email
- maria.depandis@sanraffaele.it
- Contact Person Name
- Maria Francesca De Pandis
- Contact Person Email
- maria.depandis@sanraffaele.it
- Site Name
- Irccs San Raffaele Roma S.r.l. (Rome)
- Department Name
- Department of Neurology – Clinical Trial Center
- Principal Investigator Name
- Fabrizio Stocchi
- Principal Investigator Email
- fabrizio.stocchi@sanraffaele.it
- Contact Person Name
- Fabrizio Stocchi
- Contact Person Email
- fabrizio.stocchi@sanraffaele.it
- Site Name
- Azienda USL Toscana Sud Est
- Department Name
- Ospedale della Misericordia, UOC Neurologia
- Principal Investigator Name
- Roberto Marconi
- Principal Investigator Email
- roberto.marconi@uslsudest.toscana.it
- Contact Person Name
- Roberto Marconi
- Contact Person Email
- roberto.marconi@uslsudest.toscana.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O Neurologia I
- Principal Investigator Name
- Alberto Albanese
- Principal Investigator Email
- alberto.albanese@humanitas.it
- Contact Person Name
- Alberto Albanese
- Contact Person Email
- alberto.albanese@humanitas.it
Poland
- Latest Decision Or Authorization Date
- 17-05-2024
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
- Department Name
- Not applicable
- Principal Investigator Name
- Andrzej Bogucki
- Principal Investigator Email
- andrzej.bogucki@umed.lodz.pl
- Contact Person Name
- Andrzej Bogucki
- Contact Person Email
- andrzej.bogucki@umed.lodz.pl
- Site Name
- Krakowska Akademia Neurologii Sp. z o.o.
- Department Name
- Not applicable
- Principal Investigator Name
- Monika Rudzińska-Bar
- Principal Investigator Email
- mrudzinska@sum.edu.pl
- Contact Person Name
- Monika Rudzińska-Bar
- Contact Person Email
- mrudzinska@sum.edu.pl
- Site Name
- Neuro-Care Sp. z o.o. sp.k.
- Department Name
- Not applicable
- Principal Investigator Name
- Gabriela Kłodowska
- Principal Investigator Email
- g.klodowska@neuro-care.pl
- Contact Person Name
- Gabriela Kłodowska
- Contact Person Email
- g.klodowska@neuro-care.pl
Slovakia
- Latest Decision Or Authorization Date
- 20-05-2024
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- University Hospital Bratislava
- Department Name
- II. Neurologicka klinika LF UK a UNB
- Principal Investigator Name
- Peter Valkovic
- Principal Investigator Email
- peter.valkovic@gmail.com
- Contact Person Name
- Peter Valkovic
- Contact Person Email
- peter.valkovic@gmail.com
France
- Latest Decision Or Authorization Date
- 11-06-2024
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Centre d’Investigation Clinique Service de Neurologie B8
- Principal Investigator Name
- Olivier RASCOL
- Principal Investigator Email
- olivier.rascol@univ-tlse3.fr
- Contact Person Name
- Olivier RASCOL
- Contact Person Email
- olivier.rascol@univ-tlse3.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Giovanni Castelnovo
- Principal Investigator Email
- giovanni.castelnovo@chu-nimes.fr
- Contact Person Name
- Giovanni Castelnovo
- Contact Person Email
- giovanni.castelnovo@chu-nimes.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Ana Raquel MARQUES
- Principal Investigator Email
- ar_marques@chu-clermontferrand.fr
- Contact Person Name
- Ana Raquel MARQUES
- Contact Person Email
- ar_marques@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- 264 rue Saint Pierre
- Principal Investigator Name
- Jean-Philippe AZULAY
- Principal Investigator Email
- jean-philippe.azulay@ap-hm.fr
- Contact Person Name
- Jean-Philippe AZULAY
- Contact Person Email
- jean-philippe.azulay@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de neurologie
- Principal Investigator Name
- Caroline GIORDANA
- Principal Investigator Email
- giordana.c@chu-nice.fr
- Contact Person Name
- Caroline GIORDANA
- Contact Person Email
- giordana.c@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Unite d’Investigation Clinique (UIC) - neurologie
- Principal Investigator Name
- Anne-Gaelle CORBILLE
- Principal Investigator Email
- annagaelle.corbille@chu-nantes.fr
- Contact Person Name
- Anne-Gaelle CORBILLE
- Contact Person Email
- annagaelle.corbille@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hopital de jour recherche (Unite 502 - Recherche)
- Principal Investigator Name
- Chloe LAURENCIN
- Principal Investigator Email
- chloe.laurencin@chu-lyon.fr
- Contact Person Name
- Chloe LAURENCIN
- Contact Person Email
- chloe.laurencin@chu-lyon.fr
Spain
- Latest Decision Or Authorization Date
- 22-05-2024
- Number Of Sites
- 8
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Neurology
- Principal Investigator Name
- Ernest Balaguer Martínez
- Principal Investigator Email
- ebalaguer@quironsalud.es
- Contact Person Name
- Ernest Balaguer Martínez
- Contact Person Email
- ebalaguer@quironsalud.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Jorge Hernandez Varas
- Principal Investigator Email
- hernandezvarajorge76@gmail.com
- Contact Person Name
- Jorge Hernandez Varas
- Contact Person Email
- hernandezvarajorge76@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Neurology
- Principal Investigator Name
- Francisco Grandas
- Principal Investigator Email
- francisco.grandas@salud.madrid.org
- Contact Person Name
- Francisco Grandas
- Contact Person Email
- francisco.grandas@salud.madrid.org
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Neurology
- Principal Investigator Name
- Lydia López Manzanares
- Principal Investigator Email
- lydialopez@hotmail.com
- Contact Person Name
- Lydia López Manzanares
- Contact Person Email
- lydialopez@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Jaime Kulisevski
- Principal Investigator Email
- jkulisevsky@santpau.cat
- Contact Person Name
- Jaime Kulisevski
- Contact Person Email
- jkulisevsky@santpau.cat
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology
- Principal Investigator Name
- Pablo Mir Rivera
- Principal Investigator Email
- pmir@us.es
- Contact Person Name
- Pablo Mir Rivera
- Contact Person Email
- pmir@us.es
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Neurology
- Principal Investigator Name
- Eric Freire Alvarez
- Principal Investigator Email
- dr.freyre@gmail.com
- Contact Person Name
- Eric Freire Alvarez
- Contact Person Email
- dr.freyre@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Juan Carlos Martínez Castrillo
- Principal Investigator Email
- jmcastrillo@gmail.com
- Contact Person Name
- Juan Carlos Martínez Castrillo
- Contact Person Email
- jmcastrillo@gmail.com
Belgium
- Latest Decision Or Authorization Date
- 21-05-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
- Department Name
- Neurology
- Principal Investigator Name
- Marta Lamartine
- Principal Investigator Email
- mlamarti@chu-tivoli.be
- Contact Person Name
- Marta Lamartine
- Contact Person Email
- mlamarti@chu-tivoli.be
Portugal
- Latest Decision Or Authorization Date
- 17-05-2024
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao (Hospital Braga)
- Department Name
- Hospital Braga
- Principal Investigator Name
- Sara Varanda
- Principal Investigator Email
- sara.varanda@ulsb.min-saude.pt
- Contact Person Name
- Sara Varanda
- Contact Person Email
- sara.varanda@ulsb.min-saude.pt
- Site Name
- CNS Saude Lda.
- Department Name
- Neurology
- Principal Investigator Name
- Joaquim Ferreira
- Principal Investigator Email
- joaquimjferreira@gmail.com
- Contact Person Name
- Joaquim Ferreira
- Contact Person Email
- joaquimjferreira@gmail.com
Sponsor
Primary sponsor
- Full Name
- Neuroderm Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Israel
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- clinical trial educator
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- multiple operational roles (sponsorDuties codes: 1,11,12,2,6,7,8)
- Name
- WCG Clinical Inc.
- Responsibilities
- sponsorDuties code: 8
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties code: 7
Third parties
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"patient transport","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Novasco","duties_or_roles":"patient transport","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Medical product shipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"equipment rental","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"clinical trial educator","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"sponsorDuties codes: 1,11,12,2,6,7,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ND0612
- Active Substance
- carbidopa, levodopa
- Modality
- Small molecule
- Routes Of Administration
- Subcutaneous (continuous subcutaneous infusion)
- Route
- Subcutaneous
- Authorisation Status
- Authorised (prodAuthStatus: 1 indicated in product record)
- Frequency
- Continuous subcutaneous infusion (as per protocol title and device information)
- Maximum Dose
- 720 mg/day
- Investigational Product Name
- IR-LD/CD
- Active Substance
- carbidopa, levodopa
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus: 1 indicated in product record)
- Frequency
- Multiple daily oral doses; inclusion requires at least 4 doses/day of LD/DDI (or ≥3 doses/day for extended release) and at least 400 mg/day levodopa or equivalent
- Maximum Dose
- At least 400 mg/day levodopa (per inclusion criteria)
- Investigational Product Name
- PLACEBO for LD/CD Capsules (white)
- Modality
- Other
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Authorisation Status
- Not applicable / placebo
- Investigational Product Name
- PLACEBO for LD/CD Capsules (grey)
- Modality
- Other
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Authorisation Status
- Not applicable / placebo
- Investigational Product Name
- PLACEBO TO ND0612 (solution for infusion, subcutaneous)
- Modality
- Other
- Routes Of Administration
- Subcutaneous (solution for infusion)
- Route
- Subcutaneous
- Authorisation Status
- Not applicable / placebo
- Combination Treatment
- Yes
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