Parkinson DiseasePhase 2DAPA-PDNCT07157735
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
A Phase 2 study testing dapansutrile in people with Parkinson Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- dapansutrile
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in the trial, the potential participant must:
- Have given written informed consent to participate.
- Be aged between 50 and 80 years (inclusive) at the time of the screening visit.
- Be a fluent English speaker.
- Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease.
- Have a disease duration of less than 5 years at the time of screening visit.
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- Have early-stage PD, defined as Hoehn and Yahr stage ≤2.
- Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline.
- Have hsCRP ≥ 1 mg/L on a blood test done within 2 years prior to, or at, the screening visit.
- Have adequate organ function, as defined below (to be rechecked prior to baseline/investigational medicinal product [IMP] initiation if >42 days from screening visit): Haemoglobin ≥ 110 g/L; Platelet count ≥ 130 × 109/L; Neutrophil count ≥ 1.5 × 109/L; Renal function: estimated glomerular filtration rate (eGFR) >45 mL/min/1.73m2; Hepatic function: alanine aminotransferase (ALT) and bilirubin < 1.5 times the institutional upper limit of normal; Thyroid function: thyroid stimulating hormone (TSH) within normal range; or if TSH is abnormal, free T4 within normal range; Corrected calcium ≤ institutional upper limit of normal; Alkaline phosphatase (ALP) < 1.5 times the institutional upper limit of normal
Who cannot join
- The presence of any of the following will preclude inclusion:
- Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline.
- Any previous use of rituximab or alemtuzumab at any time.
- Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline.
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin > 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week.
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- Clinically significant inflammatory or autoimmune disease.
- Chronic or latent infection.
- Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline.
- Skin, solid organ or haematological malignancy which is active* at screening, or between screening and baseline (*defined as cancer which is under active management, with the exception of low-grade malignancy under observation or hormonal treatment).
- The inability to take or swallow oral medication.
- Parkinson's Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria.
- A known genetic mutation associated with PD.
- A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV) or syphilis.
- Chronic liver disease.
- Any concurrent medical or psychiatric condition or disease that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial.
- Women of childbearing potential - female participants must be surgically sterile or be post-menopausal. (A post-menopausal state is defined as no menses for 12 months without an alternative medical cause).
- Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after the last dose of the trial treatment.
- Known hypersensitivity to dapansutrile or its excipients.
- Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another interventional investigational trial. Participants currently enrolled in other observational studies may be recruited.
- Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes.
- Concomitant treatment with any medications that could interfere with [18F]-DPA714 binding (e.g., certain benzodiazepines), with the exception of medications which can be safely withheld for an appropriate washout period prior to imaging at the investigator's discretion.
- Current use of any drugs of abuse or average alcohol intake of >21units per week over the last 3 months.
- Any other significant disease, disability or investigation result which, in the opinion of the Chief Investigator (CI), may either put the participant at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
John Van Geest Centre for Brain Repair
Cambridge, CB2 0PY
About this study
Official title: Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.
Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.
Read more
The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:
- is dapansutrile safe and well-tolerated in people with Parkinson's?
- does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial.
Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.
Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.
Read the detailed description
DAPA-PD is a randomised double-blind, placebo-controlled phase II trial investigating the safety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people with early PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence of peripheral inflammation (high sensitivity C-reactive protein [hsCRP] ≥1) as an adjunct to dopaminergic therapies. 36 participants will be recruited at a single site and treated with either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of 6 months. This randomised placebo-controlled phase of the trial will be followed by an optional 6-month open label phase, where all participants will receive the active drug. The primary endpoint will be the safety and tolerability of dapansutrile over the 6-month placebo-controlled phase.
Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
- Conditions
- Parkinson Disease
- Being tested
- dapansutrile, placebo
- Keywords
- Dapansutrile, Neurodegeneration, Neuroinflammation, Inflammation, NLRP3 inflammasome
- Medical subject headings
- Parkinson Disease, Nerve Degeneration, Neuroinflammatory Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapansutrileDrug
Dapansutrile tablets administered for 26 weeks, starting at 1,000 mg daily (500 mg twice daily) for 4 weeks, escalated to 2,000 mg daily (1,000 mg twice daily) thereafter.
placeboDrug
Matched placebo tablets administered for 26 weeks, admistered as per the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Research | Active comparator | Not described Receives: Drug: dapansutrile |
| Control | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs) recorded during the 6-month double-blind period
Adverse events are recorded from the point of participant informed consent and at every trial visit
Measured: Assessed at screening, baseline, day 1, and weeks 2, 4, 6, 12, 18, 23 and 26.
Secondary outcomes (18)
Change in [¹⁸F]-DPA-714 PET non-displaceable binding potential in the whole brain, and subcortical and cortical regions of interest
Measured using PET- magnetic resonance (MR) brain imaging with [¹⁸F]-DPA-714, a TSPO ligand.
Measured: Between baseline and week 23
Change in concentration of C-reactive protein (CRP) in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interleukin (IL)-1β in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interferon (IFN)-γ in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-18 in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-6 in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of tumour necrosis factor (TNF)-α in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of apoptosis-associated speck-like protein containing a CARD (ASC) specks in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in blood
Measured: Over 6 months of treatment, measured at day 1, and weeks 6, 18, and 26
Change in concentration of CRP in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-1β in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IFN-γ in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-18 in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-6 in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of TNF-α in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of ASC specks in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in CSF
Measured: Over 6 months of treatment, measured at baseline and week 26
Pharmacokinetics as measured by changes in plasma and CSF dapansutrile concentrations
Measured: Over 6 months of treatment; measured in the blood at day 1, and weeks 6, 18 and 26; and measured in CSF at baseline and week 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start2 Feb 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Optional open-label phase after 6 months
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Olatec Therapeutics, Inc., Cure Parkinson's, Van Andel Research Institute
- Responsible party
- Principal investigator, Caroline Williams-Gray, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Caroline Williams-Gray, BMBCh MA(Cantab) FRCP PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157735
- Sponsor's protocol ID
- CCTU0443
- Other IDs
- 1010807
- Acronym
- DAPA-PD
- Status last verified
- Jun 2026
- First submitted
- 15 May 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT07157735
- Acronym / sponsor ID
- DAPA-PD / CCTU0443
- Conditions
- Parkinson Disease
- Keywords
- Dapansutrile, Neurodegeneration, Neuroinflammation, Inflammation, NLRP3 inflammasome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, Olatec Therapeutics, Inc., Cure Parkinson's, Van Andel Research Institute
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Sep 2025 (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.
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.
Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.
The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:
- is dapansutrile safe and well-tolerated in people with Parkinson's?
- does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial.
Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.
Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.
Detailed description
DAPA-PD is a randomised double-blind, placebo-controlled phase II trial investigating the safety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people with early PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence of peripheral inflammation (high sensitivity C-reactive protein [hsCRP] ≥1) as an adjunct to dopaminergic therapies. 36 participants will be recruited at a single site and treated with either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of 6 months. This randomised placebo-controlled phase of the trial will be followed by an optional 6-month open label phase, where all participants will receive the active drug. The primary endpoint will be the safety and tolerability of dapansutrile over the 6-month placebo-controlled phase.
Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Optional open-label phase after 6 months
| Arm | Type | Receives |
|---|---|---|
| Research | Active comparator | Drug: dapansutrile |
| Control | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent to participate.
- Be aged between 50 and 80 years (inclusive) at the time of the screening visit.
- Be a fluent English speaker.
- Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease.
- Have a disease duration of less than 5 years at the time of screening visit.
Key exclusion criteria (24 listed)
- Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline.
- Any previous use of rituximab or alemtuzumab at any time.
- Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline.
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin > 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week.
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 |
|---|---|---|
| dapansutrileDapansutrile tablets administered for 26 weeks, starting at 1,000 mg daily (500 mg twice daily) for 4 weeks, escalated to 2,000 mg daily (1,000 mg twice daily) thereafter. | Drug | Research |
| placeboMatched placebo tablets administered for 26 weeks, admistered as per the active treatment. | Drug | Control |
Primary outcome
Number of adverse events (AEs) recorded during the 6-month double-blind period
Time frame: Assessed at screening, baseline, day 1, and weeks 2, 4, 6, 12, 18, 23 and 26.
Adverse events are recorded from the point of participant informed consent and at every trial visit
18 secondary outcomes
Change in [¹⁸F]-DPA-714 PET non-displaceable binding potential in the whole brain, and subcortical and cortical regions of interest
Time frame: Between baseline and week 23
Change in concentration of C-reactive protein (CRP) in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interleukin (IL)-1β in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interferon (IFN)-γ in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-18 in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-6 in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of tumour necrosis factor (TNF)-α in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of apoptosis-associated speck-like protein containing a CARD (ASC) specks in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18, and 26
Change in concentration of CRP in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-1β in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IFN-γ in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-18 in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-6 in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of TNF-α in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of ASC specks in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26
Pharmacokinetics as measured by changes in plasma and CSF dapansutrile concentrations
Time frame: Over 6 months of treatment; measured in the blood at day 1, and weeks 6, 18 and 26; and measured in CSF at baseline and week 26.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Caroline Williams-Gray, BMBCh MA(Cantab) FRCP PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dapansutrile in people with Parkinson Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 10 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Coordinator (44 1223 331160, mcd68@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) recorded during the 6-month double-blind period (time frame: Assessed at screening, baseline, day 1, and weeks 2, 4, 6, 12, 18, 23 and 26.). 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 3 Nov 2026.