ClinicalTrials.Veeva

Menu

Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's Disease (ANDANTE)

Teva Pharmaceuticals logo

Teva Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Parkinson's Disease

Treatments

Drug: Rasagiline
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01049984
TVP-1012/PM103

Details and patient eligibility

About

To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.

Enrollment

328 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
    1. Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
    1. Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
  • Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
  • Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
  • Hoehn & Yahr > 1 (symptoms on only one side of the body) with treatment and < 3 (mild to moderate bilateral disease; some postural instability; physically independent).
  • Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.
  • For patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening.
  • Medically stable outpatients (Investigator's judgment).

Exclusion criteria

  • receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
  • receive levodopa > 21 consecutive days within 90 days prior baseline
  • moderate to severe motor fluctuations
  • hepatic impairment
  • investigational medications 30 days preceding baseline
  • dopamine agonist use > 5 years prior to baseline
  • major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
  • significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than 26.
  • impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
  • pregnant or lactating or planning on becoming pregnant in the next 18 weeks
  • uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
  • Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

328 participants in 2 patient groups, including a placebo group

Rasagiline 1 mg
Experimental group
Description:
Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
Treatment:
Drug: Rasagiline
Placebo
Placebo Comparator group
Description:
Participants took a matching placebo tablet once daily for 18 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

58

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems