NCT02172573

Brief Summary

The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P50-P75 for phase_3 parkinson-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
14 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)

    Baseline and week 12

  • Change from baseline in total score of UPDRS Part III (Motor Examination)

    Baseline and week 12

Secondary Outcomes (14)

  • Changes from baseline in sores of individual items on UPDRS Part II

    Baseline and weeks 2, 4, 6, 8, 10, 12

  • Changes from baseline in scores of individual items on UPDRS Part III

    Baseline and weeks 2, 4, 6, 8, 10, 12

  • Change from baseline in area under the curve (AUC) in the UPDRS Part II score

    Baseline and weeks 2, 4, 6, 8, 10, 12

  • Change from baseline in area under the curve (AUC) in the UPDRS Part III score

    Baseline and weeks 2, 4, 6, 8, 10, 12

  • Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)

    Baseline and weeks 2, 4, 6, 8, 10, 12

  • +9 more secondary outcomes

Study Arms (3)

Pramipexole

EXPERIMENTAL
Drug: Pramipexole

Bromocriptine

EXPERIMENTAL
Drug: Bromocriptine

Placebo

PLACEBO COMPARATOR
Drug: Placebo pramipexoleDrug: Placebo bromocriptine

Interventions

PramipexoleDRUG
Pramipexole
BromocriptineDRUG
Bromocriptine
Placebo pramipexoleDRUG
Placebo
Placebo bromocriptineDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
  • Patients who were at least 20 years of age
  • In- or outpatients of either sex
  • Patients in any stage on the modified Hoehn and Yahr scale
  • Patients being treated with L-dopa who have any of the following clinical conditions and problems
  • Patients with the wearing-off phenomenon
  • Patients with the on-off phenomenon
  • Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event
  • Patients in whom the effect of L-dopa is attenuated
  • Patients in whom a dose increase of L-dopa has been refrained
  • Patients with freezing phenomenon

You may not qualify if:

  • Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study
  • Patients with a history of hypersensitivity to ergot preparations
  • Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour
  • Patients with subjective symptoms derived from orthostatic hypotension
  • Patients with hypotension (systolic blood pressure less than 100 mmHg)
  • Patients wiht Raynaud disease
  • Patients with peptic ulcer
  • Patients with complications such as severe cardiac, renal, hepatic disease etc.
  • Patients with a current or past history of epilepsy
  • Women who are or may be pregnant and lactating women
  • Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study
  • Patients who are incompetent to give consent
  • Others judged by the investigator or co-investigator to be ineligible as subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Interventions

PramipexoleBromocriptine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingErgotaminesErgot AlkaloidsAlkaloidsErgolinesHeterocyclic Compounds, 4 or More Rings

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

April 1, 1999

Primary Completion

July 1, 2000

Last Updated

June 24, 2014

Record last verified: 2014-06