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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04935762




Registration number
NCT04935762
Ethics application status
Date submitted
9/06/2021
Date registered
23/06/2021
Date last updated
29/08/2023

Titles & IDs
Public title
A Study of CST-103 Co-administered With CST-107 in Subjects With Parkinson's Disease Having Freezing of Gait (CLIN-012)
Scientific 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
Secondary ID [1] 0 0
CST103/CST107-CLIN-012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Freezing of Gait Symptoms in Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CST-103, CST-107, matching placebo

Experimental: CST-103/CST-107 to Placebo - 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.

Experimental: Placebo to CST-103/CST-107 - 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.


Treatment: Drugs: CST-103, CST-107, matching placebo
CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Gait as Captured by Video Recordings
Timepoint [1] 0 0
Days 1 and 14 of each Treatment Period (two 14-day periods)
Secondary outcome [1] 0 0
Freezing of Gait Symptoms
Timepoint [1] 0 0
Screening, Days 1 and 14 of each Treatment Period (two 14-day periods)
Secondary outcome [2] 0 0
Change from Baseline in CANTAB Reaction Time Task
Timepoint [2] 0 0
Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Secondary outcome [3] 0 0
Change from Baseline in CANTAB Paired Associates Learning Test
Timepoint [3] 0 0
Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Secondary outcome [4] 0 0
Change from Baseline in CANTAB Verbal Recognition Test
Timepoint [4] 0 0
Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Secondary outcome [5] 0 0
Digital wearable device (BioStamp)
Timepoint [5] 0 0
Screening, Days 1-14 of each Treatment Period (two 14-day periods)

Eligibility
Key inclusion criteria
- 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.

- 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.
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CuraSen Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04935762
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
CuraSen Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
650-475-2842
Fax 0 0
Email 0 0
info@curasen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04935762