Freezing of Gait Symptoms in Parkinson's DiseasePhase 2NCT04935762
A Study of CST-103 Co-administered With CST-107 in Subjects With Parkinson's Disease Having Freezing of Gait (CLIN-012)
A Phase 2 study of Freezing of Gait Symptoms in Parkinson's Disease, run by CuraSen Therapeutics, Inc. at 1 site in Australia.
Trial summary
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study to evaluate the effect of multiple oral doses of CST-103 in the presence of CST-107 on Freezing of Gait (FOG) symptoms in subjects with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Freezing of Gait Symptoms in Parkinson's Disease
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2024to Mar 2025
- Phase
- Phase 2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 30 and ≤ 80 years of age, at time of informed consent.
- Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria.
- At least 3 months incidence of typical freezing of gait (FOG) symptoms defined as the inability to move the feet despite the intention to walk including at least one of the following FOG patterns: start hesitancy, freezing at making turns or when passing through a doorway, spontaneous freezing during continued walking, or freezing of gait related to a simultaneous mental or physical activity.
- Freeze at least once per week (minimum score of 2 on item 3 of the FOG-Q) for at least 2 seconds (minimum score of 1 on item 4 of FOG-Q).
- Willing to attend assessment visits in the practically defined Off state having withdrawn from dopaminergic therapy: L-dopa preparations from midnight, Dopamine Agonists/Monoamine Oxidase-B Inhibitor for 36 hours prior to visit. Patients with device assisted therapies (i.e. Deep Brain Stimulation, L-dopa intestinal gel or subcutaneous apomorphine) to withdraw therapy for a minimum 30 minute period (maximum 2 hours) to achieve their clinically agreed Off state.
- Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males must agree to use a male condom from Day 1 throughout the study when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant. Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a condom during each episode of penile-vaginal penetration until after the Follow-Up Visit.
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- Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who have a male partner must have a negative serum pregnancy test result and must agree to one of the following from start of Screening through 30 days after the last study medication administration: use a reliable method of birth control, or monogamous relationship with a male partner of confirmed sterility, or practice complete abstinence.
- Females of non-childbearing potential may be enrolled if it is documented that they are postmenopausal.
- Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35 kg/m2, inclusive at Screening.
- Stable medical conditions for 3 months prior to Screening visit (e.g., controlled hypertension, dyslipidemia).
- Willing to follow the protocol requirements and comply with protocol restrictions.
- Capable of providing informed consent and complying with study procedures (completion of self-assessment rating scales and use of wearable devices). Subjects who are unable to provide consent may use a Legally Authorized Representative.
Who cannot join
- Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
- Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders, such as Schizophrenia or Bipolar Disorder, or have unstable concomitant psychiatric symptomatology.
- Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug.
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Any clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments conducted at Screening.
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- Clinically significant abnormalities of ECG, including QTcF > 450 ms, for males and QTcF > 470 ms for females, and/or heart rate < 50 beats per minute, or evidence of clinically significant bundle branch blocks, as indicated by 12-lead ECG.
- Calculated creatinine clearance of ≤70 mL/min according to the Cockcroft-Gault equation.
- Current use of any prohibited prescription medication, over-the-counter medication, or herbal supplements/products.
- Prior treatment with any investigational drug ≤90 days prior to dosing (Day 1), or ≤5 half-lives of the drug (whichever is longer), or current enrollment in any other study treatment or disease study except for observational studies.
- Known or suspected alcohol or substance abuse within the past 12 months.
- Suicidal ideation with actual intent or plan ("Yes" answer on the Columbia-Suicide Severity Rating Scale (C-SSRS) ideation items 4 or 5) within 3 months prior to study Screening.
- Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Contraindications to wearing the BioStamp digital device sensors, which include but are not limited to implanted pacemakers, defibrillators, or other active implantable devices, and known allergies.
- Known hypersensitivities to adhesives or hydrogel.
- Females who are breastfeeding.
- Any other reason for which the PI considers it is not in the best interest of the participant to undertake the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Use of CST-103 Co-administered With CST-107 on Freezing of Gait in Subjects With Parkinson's Disease
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study to evaluate the effect of multiple oral doses of CST-103 in the presence of CST-107 on Freezing of Gait (FOG) symptoms in subjects with Parkinson's Disease (PD).
Read the detailed description
Approximately 25 PD subjects with FOG symptoms will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period.
During each treatment period, subjects will receive daily doses of CST-103 co-administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 14 days.
All subjects will complete clinical and pharmacodynamic assessments during each treatment period. Pharmacokinetic blood samples will be collected prior to and after study medication administration. Pharmacodynamic blood samples will also be collected to investigate the effects of CST-103 co-administered with CST-107 on inflammatory and neurodegenerative biomarkers.
- Being tested
- CST-103, CST-107, matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CST-103, CST-107, matching placeboDrug
CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
| Study group | Role | What they receive |
|---|---|---|
| CST-103/CST-107 to Placebo | Experimental | Subjects will receive daily doses of CST-103 co-administered with CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by matching placebo for CST-103 and matching placebo for CST-107 for 14 days. Receives: Drug: CST-103, CST-107, matching placebo |
| Placebo to CST-103/CST-107 | Experimental | Subjects will receive daily doses of matching placebo for CST-103 and matching placebo for CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by daily doses of CST-103 co-administered with CST-107 for 14 days. Receives: Drug: CST-103, CST-107, matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gait as Captured by Video Recordings
Subjects are requested to get up from a chair, walk to a square box shape taped to the floor five meters ahead and complete both a left and a right turn. Freezing of Gait (FOG) is tagged in the video at any point when a participant makes a sudden and involuntary cessation of normal progression of the feet through the task. The percentage time spent with FOG will be calculated by summing all FOG episodes and dividing by the total time to complete the task.
Measured: Days 1 and 14 of each Treatment Period (two 14-day periods)
Secondary outcomes (5)
Freezing of Gait Symptoms
The Freezing of Gait Questionnaire (FOG-Q) is an assessment of FOG severity. The FOG-Q consists of six items. Responses to each item use a 5-point interval scale ranging from 0, absence of symptoms to 4, most severe stage. The total score is calculated as the sum of the individual items and ranges from 0 to 24 with a higher score indicating more severe FOG.
Measured: Screening, Days 1 and 14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Reaction Time Task
Measures changes in cognition by testing psychomotor speed (selecting a flashing circle on a touch tablet screen as quickly as possible).
Measured: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Paired Associates Learning Test
Measures changes in cognition by testing attention (remembering the location of an abstract pattern on a touch tablet screen).
Measured: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Verbal Recognition Test
Measures changes in cognition by testing memory (recall of 18 words flashed onto a touch tablet screen).
Measured: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Digital wearable device (BioStamp)
A wireless device that measures physical activity and sleep (in hours/minutes) while at home
Measured: Screening, Days 1-14 of each Treatment Period (two 14-day periods)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of Gait Symptoms in 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two 14-day periods, 2-way crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CuraSen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, CuraSen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935762
- Sponsor's protocol ID
- CST103/CST107-CLIN-012
- Status last verified
- Jul 2024
- First submitted
- 9 Jun 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Use of CST-103 Co-administered With CST-107 on Freezing of Gait in Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04935762
- Acronym / sponsor ID
- CST103/CST107-CLIN-012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CuraSen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Jun 2021 (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.
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study to evaluate the effect of multiple oral doses of CST-103 in the presence of CST-107 on Freezing of Gait (FOG) symptoms in subjects with Parkinson's Disease (PD).
Detailed description
Approximately 25 PD subjects with FOG symptoms will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period.
During each treatment period, subjects will receive daily doses of CST-103 co-administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 14 days.
All subjects will complete clinical and pharmacodynamic assessments during each treatment period. Pharmacokinetic blood samples will be collected prior to and after study medication administration. Pharmacodynamic blood samples will also be collected to investigate the effects of CST-103 co-administered with CST-107 on inflammatory and neurodegenerative biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two 14-day periods, 2-way crossover design
| Arm | Type | Receives |
|---|---|---|
| CST-103/CST-107 to Placebo | Experimental | Drug: CST-103, CST-107, matching placeboSubjects will receive daily doses of CST-103 co-administered with CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by matching placebo for CST-103 and matching placebo for CST-107 for 14 days. |
| Placebo to CST-103/CST-107 | Experimental | Drug: CST-103, CST-107, matching placeboSubjects will receive daily doses of matching placebo for CST-103 and matching placebo for CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by daily doses of CST-103 co-administered with CST-107 for 14 days. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects ≥ 30 and ≤ 80 years of age, at time of informed consent.
- Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease Brain Bank criteria.
- At least 3 months incidence of typical freezing of gait (FOG) symptoms defined as the inability to move the feet despite the intention to walk including at least one of the following FOG patterns: start hesitancy, freezing at making turns or when passing through a doorway, spontaneous freezing during continued walking, or freezing of gait related to a simultaneous mental or physical activity.
- Freeze at least once per week (minimum score of 2 on item 3 of the FOG-Q) for at least 2 seconds (minimum score of 1 on item 4 of FOG-Q).
- Willing to attend assessment visits in the practically defined Off state having withdrawn from dopaminergic therapy: L-dopa preparations from midnight, Dopamine Agonists/Monoamine Oxidase-B Inhibitor for 36 hours prior to visit. Patients with device assisted therapies (i.e. Deep Brain Stimulation, L-dopa intestinal gel or subcutaneous apomorphine) to withdraw therapy for a minimum 30 minute period (maximum 2 hours) to achieve their clinically agreed Off state.
Key exclusion criteria (17 listed)
- Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.
- Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, or Babinski sign.
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic disorders, such as Schizophrenia or Bipolar Disorder, or have unstable concomitant psychiatric symptomatology.
- Evidence of any significant clinical disorder or laboratory finding (or in the case of potassium levels below normal range) that renders the participant unsuitable for receiving an investigational drug.
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
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 |
|---|---|---|
| CST-103, CST-107, matching placeboCST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules | Drug | CST-103/CST-107 to Placebo, Placebo to CST-103/CST-107 |
Primary outcome
Change from Baseline in Gait as Captured by Video Recordings
Time frame: Days 1 and 14 of each Treatment Period (two 14-day periods)
Subjects are requested to get up from a chair, walk to a square box shape taped to the floor five meters ahead and complete both a left and a right turn. Freezing of Gait (FOG) is tagged in the video at any point when a participant makes a sudden and involuntary cessation of normal progression of the feet through the task. The percentage time spent with FOG will be calculated by summing all FOG episodes and dividing by the total time to complete the task.
5 secondary outcomes
Freezing of Gait Symptoms
Time frame: Screening, Days 1 and 14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Reaction Time Task
Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Paired Associates Learning Test
Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Verbal Recognition Test
Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Digital wearable device (BioStamp)
Time frame: Screening, Days 1-14 of each Treatment Period (two 14-day periods)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Chief Medical Officer study director
CuraSen Therapeutics, Inc.
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 of Freezing of Gait Symptoms in Parkinson's Disease, run by CuraSen Therapeutics, Inc. at 1 site in Australia.
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 12 inclusion and 17 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: withdrawn, as of the sponsor's last update on 3 Jul 2024. 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 Australia. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from Baseline in Gait as Captured by Video Recordings (time frame: Days 1 and 14 of each Treatment Period (two 14-day periods)). 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 Jul 2024.