Parkinson’s disease Nervous System Diseases
Conditions
Interventions
Current interventions as of 07/07/2026:
Pharmacoscintigraphic open-label crossover study. Participants were randomised to the sequence of treatment administration according to the randomisation schedu
Sponsors
Contera Pharma
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained prior to any trial-related activities 2. Female or male patients with a diagnosis of established Parkinson’s as per the Movement Disorder Society (MDS) Criteria and previously confirmed by a Neurologist 3. On therapy with levodopa for = 3 years and currently receiving = 3 daily doses 4. Participants should experience motor fluctuations induced by levodopa regularly, as per the judgement of the investigator 5. Participants must be 40-80 years of age (both inclusive) at the time of signing the informed consent 6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 6.1. Is a woman of nonchildbearing potential (WONCBP) OR 6.2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), with low user dependency. Contraceptive and Barrier Guidance during the study intervention period and until the final follow-up visit, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. 7. Male participants are eligible to participate if they agree to the following during the study intervention period and for a period of 3 months after the last treatment visit: 7.1. Refrain from donating sperm PLUS, either: 7.2. Be “True abstinent”, i.e., abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR 7.3. Must agree to use contraception /barrier as detailed below 7.4. Agree to use a male condom with a female partner, use of an additional highly effective contraceptive method with a failure rate of < 1% per year as described in Appendix 4 Contraceptive and Barrier Requirements 7.5. Surgically sterilized 8. BMI between 18 and 35 kg/m², inclusive 9. Functionally able and sufficiently independently mobile to comply with protocol procedures and overnight stays at the clinic 10. Willing and able to eat the standardised meals as per study-specific meal plan
Exclusion criteria
Exclusion criteria: 1. Regular levodopa regimen includes dosing after 11 pm to control nighttime problems 2. Expected to not tolerate changes in their evening antiparkinsonian schedule required by the study protocol 3. Expected not to tolerate being “OFF” during the night, which would require extra intake of levodopa during the night, after study drug administration 4. Current or recurrent disease that could affect study conduct; safety of the patients; ability of the patient to complete the study in the opinion of the investigator 5. Current or relevant previous history of serious, severe or unstable psychiatric illness, including Parkinson’s Disease, Dementia or drug-induced psychosis, as per judgement of the Investigator or based on a MMSE score <25, HAM-D score of greater than 18 6. Patients with disabling dyskinesia that could interfere with their ability to complete study procedures at the Investigator's judgement 7. Participants at high risk of falls as judged by the Investigator 8. A positive urine drug screen for drug abuse, a positive alcohol test, a history of substance abuse, including alcohol abuse (as judged by the investigator), or unwillingness to refrain from consuming alcohol for 24 hours prior to each treatment visit and when on site 9. A positive pregnancy test result for women of childbearing potential 10. Participation in another clinical study (inclusive of the final post-study examination) of an investigational drug within the 12 weeks before screening visit, or five elimination half-lives of the previous study drug, whichever is longer 11. Known hypersensitivity to IMP or similar compound or to excipients contained in the IMP formulation 12. Receiving Parkinson’s infusion therapies or DBS therapy within 12 weeks prior to screening 13. Patients with frequent use of overnight rescue medication, which could interfere with the treatment regime and measurement for the trial, as per the judgement of the investigator 14. Participant is scheduled to take prescribed medication within 14 days prior (or 5 half lives – whichever is longer) or takes over-the-counter medication within 48 hours prior to the first dose or any subsequent treatment visit which, in the opinion of the PI or medically qualified designee responsible, will interfere with the study procedures (or has the potential to affect gastric emptying and/or gut transit) or compromise safety of the patient. This includes, but is not exclusive to: 14.1. Oral preparations of iron 14.2. Antidiarrhoeals such as loperamide 14.3. Pro-kinetics such as domperidone, prucalopride or metoclopramide 14.4. Antispasmodics such as Buscopan 14.5. “natural levodopa” formulations such as mucuna pruriens 14.6. Non-selective monoamine oxidase (mao) inhibitors 14.7. Dopamine D2 receptor antagonists (e.g., risperidone, phenothiazines) 14.8. Tricyclic antidepressants 14.9. Anticholinergics 14.10. Dopamine depleting agents (e.g., tetrabenazine) 14.11. Isoniazid 14.12. Phenytoin 15. Participant has a total dosimetry value which, in the opinion of the PI or medically qualified designee/physician responsible, contraindicates their participation 16. Blood donation or significant blood loss within 3 months of screening and for the duration of the study 17. Participant has any non-removable metal objects such as metal plates, screws, etc., in their chest or abdominal area, which, in the opinion of the PI or medically qualified designee, could affect the study conduct 18. Any clinically significant f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time and location of onset and complete release of the radiolabelled tablet core of the CP-12 tablets, measured using scintigraphic imaging at 0 (pre-dose), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14 and 16 hours post-dose, for Treatment A and B, and 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14 and 16 hours post-dose for Treatment C;Pharmacokinetic parameters of levodopa and carbidopa from the CP-012 formulations measured using samples collected for bioanalysis at 0 (pre-dose), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14 and 16 hours post-dose, for Treatment A and B, and 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14 and 16 hours post-dose for Treatment C;Previous primary outcome timepoints as of 07/07/2026: pre-determined timepoints up to 16 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of levodopa and carbidopa following single dose administration of CP-012 and Sinemet IR measured using samples collected for bioanalysis at 0 (pre-dose), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14 and 16 hours post-dose, for Treatment A and B, and 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14 and 16 hours post-dose for Treatment C;Gastrointestinal transit parameters (gastric emptying time, small intestinal transit time and colonic arrival time (where applicable)) of the CP-012 tablets measured using scintigraphic imaging at 0 (pre-dose), 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14 and 16 hours post-dose, for Treatment A and B, and 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 12, 14 and 16 hours post-dose for Treatment C;Safety and tolerability of single dose administration of CP-012 and Sinemet IR measured using the number of treatment-emergent adverse events at the end of the study;Previous key secondary outcome timepoints as of 07/07/2026: pre-determined timepoints up to 16 hours post-dose | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactLyn Corry
Outcome results
None listed