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A Phase 2 Study of K0706 for Early Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03655236
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Tracking Information
First Submitted Date  ICMJE August 18, 2018
First Posted Date  ICMJE August 31, 2018
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3 [ Time Frame: Week 40 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03655236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Change in the movement disorder society - unified Parkinson's disease rating scale [ Time Frame: Week 40 ]
  • Time from Baseline to initiation of symptomatic medication [ Time Frame: Week 40 ]
  • Change in health related quality of life as measured by the European quality of life questionnaire 5 level version [ Time Frame: Week 40 ]
  • Change in Clinician global impression severity [ Time Frame: Week 40 ]
  • Change in the scales for outcomes in Parkinson's disease - autonomic questionnaire [ Time Frame: Week 40 ]
  • Level of K0706 [ Time Frame: Week 40 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • Exploratory outcome: effect of K0706 on dopamine cell health in Parkinson's disease as detected via Dopamine Transporter Single Photon Emission Computed Tomography (DaT SPECT) brain imaging [ Time Frame: Week 40 ]
  • CSF K0706 levels progression or target engagement of K0706. [ Time Frame: Week 40 ]
  • Brain DaT SPECT - an imaging tool that is a marker of dopaminergic cell health. [ Time Frame: Week 40 ]
  • Blood K0706 levels [ Time Frame: Week 40 ]
  • Skin punch biopsy [ Time Frame: Week 40 ]
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study of K0706 for Early Parkinson's Disease
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease.
Brief Summary The study is conducted to evaluate the efficacy, safety and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Early Parkinson Disease
Intervention  ICMJE
  • Drug: K0706
    low dose, orally, once-daily
  • Drug: K0706
    high dose, orally, once-daily
  • Other: placebo
    placebo capsules, orally, once-daily
Study Arms
  • Experimental: K0706, low dose
    Intervention: Drug: K0706
  • Experimental: K0706, high dose
    Intervention: Drug: K0706
  • Placebo Comparator: Placebo, placebo capsules
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2018)
504
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key inclusion Criteria:

  1. Diagnosed with "Clinically Probable PD" according to the MDS clinical diagnostic criteria, with documented onset of symptoms per treating physician's records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2;
  2. Projected to not require to start dopaminergic therapy within 9 months from Baseline;
  3. Female subjects must be not of childbearing potential, e.g., documented evidence that they are surgically sterile (e.g., hysterectomy, partial hysterectomy, bilateral oophorectomy, bilateral tubal ligation), or post-menopausal (at least 12 months since last menses) prior to Screening with serum Follicular Stimulating Hormone (FSH) ≥40 mIU/mL).

Key exclusion Criteria:

  1. Current, or within 60 days of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study;
  2. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past;
  3. A diagnosis of a significant central or nervous system disease affecting the subject's cognition or motor function at any time, such as another neurodegenerative disorder, multiple sclerosis or stroke. This does not include transient neurological deficits such as transient ischemic attacks or migraine aura;
  4. A diagnosis of a medical condition that could interfere with interpretation of the MDS-UPDRS during the trial (e.g., musculoskeletal disorders);
  5. Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence of Dopaminergic Deficit [SWEDD]) based on central read by a study physician;
  6. MRI scan of the brain performed after onset of PD suggestive of secondary Parkinsonism (e.g., subdural hematoma, normal pressure hydrocephalus, or infarcts of the basal ganglia);
  7. Any clinically significant cardiac abnormality in the opinion of the investigator. This would include myocardial infarction in the six months prior to screening, or significant ECG abnormality, including heart-rate corrected interval QT (QTc) based on Fridericia's correction formula > 470 milliseconds;
  8. Subject report of recent (6-month) illicit drug use (other than marijuana), or excessive intake of alcohol (as per investigator opinion);
  9. Subject report of marijuana use within one month of Screening or subject not willing to forgo marijuana use through the trial;
  10. Participation in other investigational drug trials within 30 days prior to Screening;
  11. Any concomitant medication or medication excluded that could put subject at risk, or interfere with study evaluations (Section 7.4);
  12. Recent use of medications that can cause Parkinsonism and suspicion of the investigator that it could have worsened the subject's Parkinsonism. This includes neuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nausea medications (e.g., prochlorperizine, metoclopramide) and others (e.g., flunarizine, methyldopa);
  13. Use of medications that affect the dopamine system though do not cause or treat PD, within 60 days of Screening. This includes stimulants (e.g., methylphenidate, amphetamine derivatives, modafinil) and Monoamine Oxidase A (MAOA) inhibitors (e.g., phenelzine, and tranylcypromine). Note that antidepressants are acceptable as long as the subject has remained on them at a stable dose for over 60 days prior to Screening and plans to remain on them through the study;
  14. Any malignant disease other than basal cell carcinoma of the skin with evidence of disease within the past 5 years, or with the potential for recurrence;

Exclusion criteria specific for the Biomarker substudy:

  1. Contraindications to undergoing a skin biopsy (e.g., allergy to the anesthetic used, use of anticoagulants or dual anti-platelet agents, history of impaired wound healing, history of keloid formation);
  2. Contraindications for performing lumbar puncture such as coagulation disorders, back surgery that might interfere with the procedure, anticoagulants, etc
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Sun Pharma Advanced Research Company Limited +1 (609) 720-5333 clinical.trials@sparcmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03655236
Other Study ID Numbers  ICMJE CLR_18_06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sun Pharma Advanced Research Company Limited
Study Sponsor  ICMJE Sun Pharma Advanced Research Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Advanced Research Company Limited
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP