Parkinson's DiseasePhase 1NCT00875316
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
A Phase 1 study testing Cogane™ (PYM50028) in people with Parkinson's Disease, run by Phytopharm at 1 site in United Kingdom.
Trial summary
Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Cogane™ (PYM50028)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Aug 2009
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
- Females of non-childbearing potential
- General Good Health
- Male \& Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
- Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
- Subjects who are taking Parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening
Who cannot join
- No clinically significant and relevant medical history
- Smoked within the 3 months prior to screening
- Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration
- Diagnosis of dementia
- Parkinson's disease of a known genetic cause
- History of surgical intervention for Parkinson's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month
Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.
It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.
- Conditions
- Parkinson's Disease
- Being tested
- Cogane™ (PYM50028)
- Keywords
- Parkinson's disease, Phase I
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogane™ (PYM50028)Drug
Orally active neurotrophic factor inducer
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: Cogane™ (PYM50028) |
| Cohort B | Experimental | Not described Receives: Drug: Cogane™ (PYM50028) |
| Cohort C | Experimental | Not described Receives: Drug: Cogane™ (PYM50028) |
| Cohort D (Optional) | Experimental | Not described Receives: Drug: Cogane™ (PYM50028) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety and tolerability of Cogane™ oral solution
Measured: Throughout 28 day dosing period
Secondary outcomes (1)
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Measured: Throughout 28 day dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Investigator, Principal investigator, Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875316
- Sponsor's protocol ID
- P58/07CL/ST/08/01
- Other IDs
- LCG 2237/08
- Status last verified
- Aug 2009
- First submitted
- 2 Apr 2009
- Last updated
- 21 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month
- ClinicalTrials.gov ID
- NCT00875316
- Acronym / sponsor ID
- P58/07CL/ST/08/01
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- PhytopharmIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 3 Apr 2009 (estimated)
- 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.
Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.
It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Cogane™ (PYM50028) |
| Cohort B | Experimental | Drug: Cogane™ (PYM50028) |
| Cohort C | Experimental | Drug: Cogane™ (PYM50028) |
| Cohort D (Optional) | Experimental | Drug: Cogane™ (PYM50028) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
- Females of non-childbearing potential
- General Good Health
- Male \& Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
- Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
Key exclusion criteria (6 listed)
- No clinically significant and relevant medical history
- Smoked within the 3 months prior to screening
- Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration
- Diagnosis of dementia
- Parkinson's disease of a known genetic cause
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 |
|---|---|---|
| Cogane™ (PYM50028)Orally active neurotrophic factor inducer | Drug | Cohort A, Cohort B, Cohort C, Cohort D (Optional) |
Primary outcome
To investigate the safety and tolerability of Cogane™ oral solution
Time frame: Throughout 28 day dosing period
1 secondary outcome
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Time frame: Throughout 28 day dosing period
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 21 Aug 2009.
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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. This study is not recruiting at the moment.
Investigator principal investigator
Cambridge, UK
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 Cogane™ (PYM50028) in people with Parkinson's Disease, run by Phytopharm 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 6 inclusion and 6 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 21 Aug 2009. 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. 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?
To investigate the safety and tolerability of Cogane™ oral solution (time frame: Throughout 28 day dosing period). 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 21 Aug 2009.