ParkinsonPhase 1NCT06037590
A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops® Relative to INBRIJA®
A Phase 1 study testing Levodopa Cyclops® and INBRIJA® in people with Parkinson and Parkinson Disease, run by PureIMS B.V. at 1 site in Bulgaria.
Trial summary
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson, Parkinson Disease, Parkinson's Disease and Parkinsonism
- What is being tested?
- Levodopa Cyclops® and INBRIJA®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBulgaria
- Study dates
- 25 Sep 2023to 27 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subject
- Age between 18 and 55 years (inclusive the date of signing informed consent)
- Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who:
- has reached natural menopause (defined as at least 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (ii) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa)
- Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy
- List of medically accepted contraceptive methods (used at least 4 weeks prior screening visit and not to be changed for the duration of the study):
Show all 14Show fewer
- Combination of a barrier method and spermicides (film, jelly, foam): e.g. female/ male condoms with spermicides, as well as diaphragm/ cervical cap/ contraceptive sponge with spermicides.
- Hormonal methods: combined estrogen/progestin injectable and oral contraceptives; progestin injectable and oral contraceptives; implants (Nexplanon®), vaginal ring (NuvaRing®), skin patch (Xulane®) and contraceptive injection (Depo-Provera®).
- Intrauterine devices (IUD): inert or copper IUD (ParaGard®), hormonal IUD (Mirena®, Skyla®, Kyleena®).
- Physically and mentally healthy as judged by means of medical and standard laboratory examination
- Non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year) and non-users of othernicotine containing products, confirmed by urine cotinine test
- BMI within the range (including the borders) of 18.0 to 30.0 kg/m2
- Normal spirometry values at screening (forced expiratory volume in one second [FEV1] and forced vital capacity [FVC] between 80% and 120% of the average value regarding age, height, gender and ethnicity (acc. to ECCS/ERS)1
- Informed consent given in written form according to chapter 5.4 of clinical trial protocol
Who cannot join
- Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous study)
- Randomization into the present trial more than once
- Pregnant and/or nursing women. Positive pregnancy test
- Weight of less than 40 kg
- Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
- History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months before screening visit or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year before screening visit
Show all 35Show fewer
- Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
- Regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
- Positive drug screening
- Positive alcohol test
- History of significant multiple and/or severe allergies (including latex allergy, asthma or bronchial hyperreactivity), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Any history of drug hypersensitivity (especially to the active ingredient levodopa of the Test and Reference IMPs and to the active ingredient carbidopa of the AxMP) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
- Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- Clinically significant illness within 4 weeks before screening visit
- Major surgery of the gastrointestinal tract except for appendectomy
- Any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
- History of difficulty in swallowing
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- Administration of depot injectable solutions or medications with a halflife >1 week (including study medications) within 6 months before screening visit
- Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before screening visit
- Intake or administration of any systemic or topical medication (including OTC medication and especially intake of antacids e.g. aluminum hydroxide, magnesium hydroxide, and simethicone or herbal medication e.g. St. John's wort, kava kava) within 2 weeks before screening visit
- Medication with drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within 60 days before screening visit
- Systolic blood pressure outside the range of 100 to 135 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg
- Pulse rate outside the range of 50 to 90 beats/min
- Respiratory rate outside the range of 12-16 breaths/min
- Axillary body temperature outside the interval of 35.5 to 37.1°C
- Any clinically significant abnormality of the resting ECG (12-lead)
- Laboratory values outside normal range with clinical relevance
- Special diet due to any reason, e.g. vegetarians
- Subjects who are known or suspected:
- not to comply with the study directives
- not to be reliable or trustworthy
- not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in
- subject is in custody or submitted to an institution due to a judicial
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
Sofia, 1202
About this study
Official title: A Pilot Open-label, Randomized, Crossover, Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops® (Test Product) Relative to INBRIJA® (Reference Product) in Healthy Adult Subjects
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment.
This unmet medical need was addressed by the approval of INBRIJA®, an orally inhaled product, for producing therapeutic relief during the OFF episodes. INBRIJA® is a capsule-based inhaler system and in order to administer the full dose of levodopa, the patients need to inhale the contents of two capsules. In order to administer the full dose of levodopa, patients need to inhale the contents of two capsules. Since the INBRIJA® device is a standalone and reusable unit, the patients have to load the capsule prior to inhalation several times a day during the OFF episodes (except early-morning OFF) to get relief. Also, the INBRIJA® device is repeatedly used by PD patients and therefore needs to be properly cleaned to avoid contamination.
Read more
PureIMS is developing a more user-friendly alternative called Levodopa Cyclops®, a pre-filled drug-device combination of levodopa inhalation powder for use with the Cyclops® dry powder inhaler. Due to the nature of the Cyclops®, it offers PD patients greater ease and convenience in use. Moreover, the device's moderate to high resistance to airflow and minimal use of excipients suggests minimal cough episodes during oral inhalation.
The current study is planned in order to determine the dose at which comparative bioavailability of Levodopa Cyclops® will be reached compared to INBRIJA®.
Read the detailed description
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment. This unmet medical need was addressed by the approval of INBRIJA®, an orally inhaled product, which releases levodopa in the systemic circulation for producing therapeutic relief during the OFF episodes.
The INBRIJA® inhaler system is based on a spray-dried powder and contains 90% of levodopa, 8% dipalmitoyl phosphatidylcholine, and 2% sodium chloride. In order to administer the full dose of levodopa, patients need to inhale the contents of two capsules. Since the INBRIJA® device is a standalone and reusable unit, the patients have to load the capsule prior to inhalation several times a day during the OFF episodes (except early-morning OFF) to get relief. Also, the INBRIJA® device is repeatedly used by PD patients and therefore needs to be properly cleaned to avoid contamination.
PureIMS is developing a drug-device combination product called Levodopa Cyclops®, a pre-filled drug-device combination of levodopa inhalation powder for use with the Cyclops® dry powder inhaler. The ready-to-use Cyclops® carries a high load of drug (i.e., 98% levodopa with only 2% L-leucine serving as the excipient). Due to the nature of the Cyclops®, it offers PD patients greater ease and convenience in use. Moreover, the device's moderate to high resistance to airflow and minimal use of excipients suggests minimal cough episodes during oral inhalation.
Levodopa Cyclops® has shown safety and tolerability in PD patients with no reports of cough episodes. The pharmacokinetics (PK) at 30, 60 and 90 mg Levodopa Cyclops® doses show a dose proportional increase of exposure (Cmax and AUC) with a rapid attainment of Cmax (within 10 minutes after oral inhalation using Levodopa Cyclops®).
PureIMS plans to pursue drug development in the US via the 505(b)(2) regulatory pathway, referencing the safety and efficacy findings of the FDA for the approved levodopa inhaler INBRIJA®.
The current study is planned in order to determine the dose at which comparable relative bioavailability of Levodopa Cyclops® will be reached compared to INBRIJA®. The selected Levodopa Cyclops® dose will then be investigated against INBRIJA® in a formal comparative bioavailability study, in order to provide a PK bridge of Levodopa Cyclops® to the reference listed drug.
- Being tested
- Levodopa Cyclops®, INBRIJA®
- Keywords
- Cyclops®, Levodopa Cyclops®, Cyclops, Inhaled levodopa, OFF episodes, motor fluctuations
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa Cyclops®Combination product
Orally inhaled dry powder levodopa from the Cyclops® dry powder inhaler
INBRIJA®Combination product
Orally inhaled dry powder levodopa from the ARCUS® dry powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| Test 1 - Levodopa Cyclops® 45 mg | Experimental | 1 pre-filled single-use Levodopa Cyclops® (= 45 mg levodopa) Receives: Combination Product: Levodopa Cyclops® |
| Test 2 - Levodopa Cyclops® 90 mg | Experimental | 2 pre-filled single-use Levodopa Cyclops® devices (= 90 mg levodopa) Receives: Combination Product: Levodopa Cyclops® |
| Test 3 - Levodopa Cyclops™ 135 mg | Experimental | 3 pre-filled single-use Levodopa Cyclops® devices (= 135 mg levodopa) Receives: Combination Product: Levodopa Cyclops® |
| Reference - Inbrija® 84 mg | Active comparator | 2 Inbrija® capsules (42 mg levodopa per capsule) from the Arcus® dry powder inhaler Receives: Combination Product: INBRIJA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops® versus Inbrija®
The primary objective of the present trial is to determine the dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops® versus Inbrija® in healthy adult subjects after an oral inhalation of a single dose of 45, 90 and 135 mg levodopa under fasting conditions administered with 50 mg carbidopa one hour prior IMP administration in 3 study periods and after a single dose of 66 mg levodopa delivered dose (2 hard capsules containing 42 mg levodopa each) of Inbrija® administered with carbidopa 50 mg one hour prior to IMP administration in a fourth study period.
Measured: 5 days
Secondary outcomes (3)
The time to reach a levodopa plasma concentration above 400 ng/mL as a measure for the onset of action.
In the scientific literature it is stated that levodopa is effective at plasma concentrations above 400 ng/mL, therefore, the time it takes to reach this concentration with Levodopa Cyclops® and Inbrija® is of interest and is indicative for the onset of action.
Measured: 5 days
The time above a levodopa plasma concentration 400 ng/mL as a measure for the duration of effect.
In the scientific literature it is stated that levodopa is effective at plasma concentrations above 400 ng/mL, therefore, the time above this concentration after a Levodopa Cyclops® dose or Inbrija® dose is of interest.
Measured: 5 days
Safety and tolerability of Levodopa Cyclops® by measuring vital signs, laboratory examination and adverse events questioning
Before and after the study:
- Vital signs (body temperature, pulse rate, respiratory rate, blood pressure)
- 12-lead ECG
- Laboratory examination blood and urine (Hematology, Chemistry, Serology, Serum FSH in females, Urinalysis)
After each dose:
- Adverse event questioning
- Vital signs (pulse rate and blood pressure) measurement at 50 minutes post-dose
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Sep 2023
- Primary completion20 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, crossover, comparative bioavailability study in healthy volunteers
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- PureIMS B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cooperative Clinical Drug Research and Development AG (CCDRD AG)
- Responsible party
- Sponsor
- Investigators
- Ivo Bogdanov, MD, Principal investigator, Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037590
- Sponsor's protocol ID
- 2023-504687-42-00
- Other IDs
- 2023
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open-label, Randomized, Crossover, Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops® (Test Product) Relative to INBRIJA® (Reference Product) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06037590
- Acronym / sponsor ID
- 2023-504687-42-00
- Keywords
- Cyclops®, Levodopa Cyclops®, Cyclops, Inhaled levodopa, OFF episodes, motor fluctuations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- PureIMS B.V.Industry (pharma, biotech, devices)
- Collaborators
- Cooperative Clinical Drug Research and Development AG (CCDRD AG)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment.
This unmet medical need was addressed by the approval of INBRIJA®, an orally inhaled product, for producing therapeutic relief during the OFF episodes. INBRIJA® is a capsule-based inhaler system and in order to administer the full dose of levodopa, the patients need to inhale the contents of two capsules. In order to administer the full dose of levodopa, patients need to inhale the contents of two capsules. Since the INBRIJA® device is a standalone and reusable unit, the patients have to load the capsule prior to inhalation several times a day during the OFF episodes (except early-morning OFF) to get relief. Also, the INBRIJA® device is repeatedly used by PD patients and therefore needs to be properly cleaned to avoid contamination.
PureIMS is developing a more user-friendly alternative called Levodopa Cyclops®, a pre-filled drug-device combination of levodopa inhalation powder for use with the Cyclops® dry powder inhaler. Due to the nature of the Cyclops®, it offers PD patients greater ease and convenience in use. Moreover, the device's moderate to high resistance to airflow and minimal use of excipients suggests minimal cough episodes during oral inhalation.
The current study is planned in order to determine the dose at which comparative bioavailability of Levodopa Cyclops® will be reached compared to INBRIJA®.
Detailed description
Patients with Parkinson's disease (PD) are commonly treated with a combination of levodopa and a decarboxylase inhibitor (DCI). However, many PD patients experience motor fluctuations (OFF episodes), even with their regular levodopa/DCI treatment. This unmet medical need was addressed by the approval of INBRIJA®, an orally inhaled product, which releases levodopa in the systemic circulation for producing therapeutic relief during the OFF episodes.
The INBRIJA® inhaler system is based on a spray-dried powder and contains 90% of levodopa, 8% dipalmitoyl phosphatidylcholine, and 2% sodium chloride. In order to administer the full dose of levodopa, patients need to inhale the contents of two capsules. Since the INBRIJA® device is a standalone and reusable unit, the patients have to load the capsule prior to inhalation several times a day during the OFF episodes (except early-morning OFF) to get relief. Also, the INBRIJA® device is repeatedly used by PD patients and therefore needs to be properly cleaned to avoid contamination.
PureIMS is developing a drug-device combination product called Levodopa Cyclops®, a pre-filled drug-device combination of levodopa inhalation powder for use with the Cyclops® dry powder inhaler. The ready-to-use Cyclops® carries a high load of drug (i.e., 98% levodopa with only 2% L-leucine serving as the excipient). Due to the nature of the Cyclops®, it offers PD patients greater ease and convenience in use. Moreover, the device's moderate to high resistance to airflow and minimal use of excipients suggests minimal cough episodes during oral inhalation.
Levodopa Cyclops® has shown safety and tolerability in PD patients with no reports of cough episodes. The pharmacokinetics (PK) at 30, 60 and 90 mg Levodopa Cyclops® doses show a dose proportional increase of exposure (Cmax and AUC) with a rapid attainment of Cmax (within 10 minutes after oral inhalation using Levodopa Cyclops®).
PureIMS plans to pursue drug development in the US via the 505(b)(2) regulatory pathway, referencing the safety and efficacy findings of the FDA for the approved levodopa inhaler INBRIJA®.
The current study is planned in order to determine the dose at which comparable relative bioavailability of Levodopa Cyclops® will be reached compared to INBRIJA®. The selected Levodopa Cyclops® dose will then be investigated against INBRIJA® in a formal comparative bioavailability study, in order to provide a PK bridge of Levodopa Cyclops® to the reference listed drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open-label, randomized, crossover, comparative bioavailability study in healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Test 1 - Levodopa Cyclops® 45 mg | Experimental | Combination Product: Levodopa Cyclops®1 pre-filled single-use Levodopa Cyclops® (= 45 mg levodopa) |
| Test 2 - Levodopa Cyclops® 90 mg | Experimental | Combination Product: Levodopa Cyclops®2 pre-filled single-use Levodopa Cyclops® devices (= 90 mg levodopa) |
| Test 3 - Levodopa Cyclops™ 135 mg | Experimental | Combination Product: Levodopa Cyclops®3 pre-filled single-use Levodopa Cyclops® devices (= 135 mg levodopa) |
| Reference - Inbrija® 84 mg | Active comparator | Combination Product: INBRIJA®2 Inbrija® capsules (42 mg levodopa per capsule) from the Arcus® dry powder inhaler |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female subject
- Age between 18 and 55 years (inclusive the date of signing informed consent)
- Female subject who IS NOT of reproductive potential. A female subject who is NOT of reproductive potential is defined as one who:
- Female subject who IS of reproductive potential and uses reliable contraception method and/or is willing to use adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy
- List of medically accepted contraceptive methods (used at least 4 weeks prior screening visit and not to be changed for the duration of the study):
Key exclusion criteria (35 listed)
- Participation in another clinical trial at same time or within 90 days before screening visit (calculated from the date of the final examination of the previous study)
- Randomization into the present trial more than once
- Pregnant and/or nursing women. Positive pregnancy test
- Weight of less than 40 kg
- Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa Cyclops®Orally inhaled dry powder levodopa from the Cyclops® dry powder inhaler | Combination product | Test 1 - Levodopa Cyclops® 45 mg, Test 2 - Levodopa Cyclops® 90 mg, Test 3 - Levodopa Cyclops™ 135 mg |
| INBRIJA®Orally inhaled dry powder levodopa from the ARCUS® dry powder inhaler | Combination product | Reference - Inbrija® 84 mg |
Primary outcome
The dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops® versus Inbrija®
Time frame: 5 days
The primary objective of the present trial is to determine the dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops® versus Inbrija® in healthy adult subjects after an oral inhalation of a single dose of 45, 90 and 135 mg levodopa under fasting conditions administered with 50 mg carbidopa one hour prior IMP administration in 3 study periods and after a single dose of 66 mg levodopa delivered dose (2 hard capsules containing 42 mg levodopa each) of Inbrija® administered with carbidopa 50 mg one hour prior to IMP administration in a fourth study period.
3 secondary outcomes
The time to reach a levodopa plasma concentration above 400 ng/mL as a measure for the onset of action.
Time frame: 5 days
The time above a levodopa plasma concentration 400 ng/mL as a measure for the duration of effect.
Time frame: 5 days
Safety and tolerability of Levodopa Cyclops® by measuring vital signs, laboratory examination and adverse events questioning
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivo Bogdanov, MD principal investigator
Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levodopa Cyclops® and INBRIJA® in people with Parkinson and Parkinson Disease, run by PureIMS B.V. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops® versus Inbrija® (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.