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A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants

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ClinicalTrials.gov Identifier: NCT02337738
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: TVP-1012 1mg Drug: TVP-1012 0.5mg Drug: Placebo Phase 2 Phase 3

Detailed Description:

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 2/3 study to evaluate the efficacy and safety of TVP-1012 as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

The study period will consist of a 28-week trial period. The participants who fulfill the inclusion criteria and do not meeting any of the exclusion criteria will be enrolled, and randomized in a 1:1:1 ratio to the 0.5 mg of TVP-1012, the 1 mg of TVP-1012, or the placebo group. In each treatment group, participants will receive 0.5 mg of TVP-1012, 1 mg of TVP-1012, or placebo once daily in a double-blinded manner.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing Off
Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
Experimental: TVP-1012 1mg Group
TVP-1012 (1 mg/day) once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
Drug: TVP-1012 1mg
TVP-1012 1mg Tablets

Experimental: TVP-1012 0.5mg Group
TVP-1012 (0.5 mg/day) once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
Drug: TVP-1012 0.5mg
TVP-1012 0.5mg Tablets

Placebo Comparator: Placebo Group
One Placebo tablet once daily orally, either before or after breakfast, concomitantly with levodopa tablet.
Drug: Placebo
Placebo Tablets




Primary Outcome Measures :
  1. Change in the mean daily off-time [ Time Frame: Baseline and Up to 28 Weeks ]
    Off-time refers to times when levodopa is not working well, causing worsening symptoms.


Secondary Outcome Measures :
  1. Mean daily off-time [ Time Frame: Up to 28 Weeks ]
  2. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II total score [ Time Frame: Up to 28 Weeks ]
    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.

  3. MDS-UPDRS Part III total score [ Time Frame: Up to 28 Weeks ]
    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.

  4. Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index score and scores for individual domains [ Time Frame: Up to 28 Weeks ]
    PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.



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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a diagnosis of Parkinson's disease according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank.
  • The participant has Modified Hoehn & Yahr stage 2 to 4 (in the "Off" state).
  • The participant has wearing off phenomenon and has been continuously receiving a levodopa combination drug for >= 6 months.
  • The participant has been receiving a levodopa combination drug without change in the dose regimen (dosing frequency, at least 3 times a day).
  • The participant has been receiving entacapone with a stable dose regimen.
  • The participant has been receiving a dopamine agonist, anticholinergic drug, amantadine, droxidopa, istradefylline, or zonisamide with a stable dose regimen.
  • The participant is an outpatient of either sex aged >= 30 and < 80 years.
  • The participant has completed patient diary for at least 4 of the 7 days.
  • The participant has mean daily off-time of >= 2.5 hours

Exclusion Criteria:

  • The participant has unstable systemic disease.
  • The participant has severe dyskinesia. The participant has Mini-Mental State Examination (MMSE) score of <= 24.
  • The participant has major depression or severe depression, or any other clinically significant psychiatric disease.
  • The participant has a history of clinically significant hypertension or other reactions associated with ingestion of tyramine-rich food.
  • The participant has received neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, deep brain stimulation).
  • The participant has received transcranial magnetic stimulation within 6 months.
  • The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa within 90 days.
  • The participant has received single agennt of levodopa, any psychoneurotic agent or antiemetic medication of dopamine agonist within 14 days. However, the participant has been receiving quetiapine or domperidone with a stable dose regimen for >= 14 days may be included in the study.
  • The participant is required to take any of the excluded medications or treatments.
  • The participant has laboratory data meeting any of the following:
  • Creatinine >= 2 x upper limit of normal (ULN)
  • Total bilirubin >= 2 x ULN
  • ALT or AST >= 1.5 x ULN
  • ALP >= 3 x ULN
  • The participant has received any of the excludeded medications or treatments.

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): NCT02337738


  Show 57 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02337738     History of Changes
Other Study ID Numbers: TVP-1012/CCT-002
U1111-1165-1364 ( Registry Identifier: WHO )
JapicCTI-152759 ( Registry Identifier: JapicCTI )
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs