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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 : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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.

Condition or disease Intervention/treatment Phase
Early Parkinson Disease Drug: K0706 Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease.
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: K0706, low dose Drug: K0706
low dose, orally, once-daily

Experimental: K0706, high dose Drug: K0706
high dose, orally, once-daily

Placebo Comparator: Placebo, placebo capsules Other: placebo
placebo capsules, orally, once-daily




Primary Outcome Measures :
  1. Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3 [ Time Frame: Week 40 ]

Secondary Outcome Measures :
  1. Change in the movement disorder society - unified Parkinson's disease rating scale [ Time Frame: Week 40 ]
  2. Time from Baseline to initiation of symptomatic medication [ Time Frame: Week 40 ]
  3. Change in health related quality of life as measured by the European quality of life questionnaire 5 level version [ Time Frame: Week 40 ]
  4. Change in Clinician global impression severity [ Time Frame: Week 40 ]
  5. Change in the scales for outcomes in Parkinson's disease - autonomic questionnaire [ Time Frame: Week 40 ]
  6. Level of K0706 [ Time Frame: Week 40 ]

Other Outcome Measures:
  1. 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 ]
  2. CSF K0706 levels progression or target engagement of K0706. [ Time Frame: Week 40 ]
  3. Brain DaT SPECT - an imaging tool that is a marker of dopaminergic cell health. [ Time Frame: Week 40 ]
  4. Blood K0706 levels [ Time Frame: Week 40 ]
  5. Skin punch biopsy [ Time Frame: Week 40 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655236


Contacts
Contact: Sun Pharma Advanced Research Company Limited +9122 66455645 clinical.trials@sparcmail.com

Locations
United States, Florida
SPARC Site 01 Recruiting
Atlantis, Florida, United States, 33411
Contact: Mark Goldstein, MD,CPI    561-968-2933      
SPARC Site 03 Recruiting
Boca Raton, Florida, United States, 33486
Contact: Stuart Isaacson, BS, MD       isaacson@ParkinsonsCenter.org   
United States, Michigan
SPARC Site 02 Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Aaron Ellenbogen, DO, MPH    248-957-8940      
United States, Washington
SPARC Site 04 Recruiting
Spokane, Washington, United States, 99202
Contact: Jason Aldred       jaldred@inwresearch.com   
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT03655236     History of Changes
Other Study ID Numbers: CLR_18_06
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases