The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa

NCT03521635 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0248-0686
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 12

Brief Summary

The main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 18 in Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score

  Parkinson's disease Sleep Scale 2nd version (PDSS-2) consists of 15 questions about various sleep and nocturnal disturbances which are to be rated by the patients using one of five categories, from 0 (never) to 4 (very often). Patients were asked to rate the severity of each question based on their experience during the past week (7 days) from 0 (Never) to 4 (Very often, that meant 6 to 7 days a week). PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance).

  Baseline and Week 18

Secondary Outcomes (9)

• Nocturnal Hypokinesia Questionnaire (NHQ) Score (Change From Baseline)

  Baseline and Week 18

• Scale for Outcomes in Parkinson's Disease (SCOPA)-Sleep Score (Change From Baseline)

  Baseline and Week 18

• Early Morning Off (EMO) Score (Change From Baseline)

  Baseline and Week 18

• Responder Rate for Parkinson's Disease Sleep Scale 2nd Version (PDSS-2) Total Score<18

  At Week 18

• Responder Rate for Early Morning Off (EMO) Score

  At Week 18

Study Arms (2)

Pramipexole SR

EXPERIMENTAL

Drug: Pramipexole SR

Pramipexole IR

ACTIVE COMPARATOR

Drug: Pramipexole IR

Interventions

Pramipexole SR DRUG

Tablets

Also known as: MIRAPEX®/SIFROL

Pramipexole SR

Pramipexole IR DRUG

Tablets

Also known as: MIRAPEX®/SIFROL

Pramipexole IR

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient with advanced idiopathic Parkinson's disease (PD) confirmed by at least bradykinesia and one of the following signs: resting tremor, rigidity.
• Diagnosed as Parkinson's disease, with at least 2 years' PD history.
• Of age ≥ 30 years at time of diagnosis.
• Modified Hoehn and Yahr stage of 2 to 4 at on-time.
• They must have clinically relevant sleep disturbances (i.e. Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score ≥18 at baseline).
• They must feel uncomfortable at night because they were unable to turn around in bed or move due to immobility (i.e. the scoring of question 9 in PDSS-2 ≥ 2, that means frequency is at least 2 to 3 days during the past week).
• They must have early morning off (i.e. the frequency of "feeling like bodily movements are poor when you wake up?" is at least 2 to 3 days during the past week).
• Patient must have motor fluctuations (at least 2 cumulative hours of off-time every day during waking hours, documented on a patient diary completed for 2 consecutive days before randomization visit).
• Patients must be treated with Levodopa combined with a Dopa-Decarboxylase-inhibitor (L-Dopa+) (i.e. standard and/or controlled release Levodopa/DDC inhibitor), or with a combination of L-Dopa+ and entacapone, at an optimized dose according to investigator's judgment, this dose being stable for at least 4 weeks prior to randomization visit.
• Patients must not have been treated with sustained release dopaminergic drug (i.e. sustained release Levodopa/Dopa-Decarboxylase (DDC) inhibitor) after supper, or any anti-PD medication after 9pm within 4 weeks prior to randomization visit.
• Patients must not have been treated with dopamine agonists within 4 weeks prior to randomization visit. A concomitant treatment with one or more of the following drugs will be allowed (at a stable dose for at least 4 weeks prior to randomization visit and the investigator does not intend to change this treatment during the treatment phase):
• Anti-parkinsonian anticholinergics;
• Selegiline, rasagiline, or other Monoamine Oxydase (MAO)-B-Inhibitor;
• Amantadine;
• Entacapone (or other Catechol-O-Methyltransferase (COMT)-Inhibitor).

You may not qualify if:

• Secondary parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
• Dementia, as defined by a Mini-Mental State Exam score \< 24 at screening visit.
• Any psychiatric disorder according to DSM-V Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.
• History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient).
• History of deep brain stimulation.
• History of nucleus lesioning.
• Clinically significant electrocardiogram (ECG) abnormalities at screening visit, according to investigator's judgement.
• Clinically significant hypotension (i.e. supine systolic blood pressure \< 90 mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic hypotension associated with a decline ≥ 20 mmHg in systolic blood pressure and a decline ≥ 10 mmHg in diastolic blood pressure, at 1 minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) at screening or randomization visit.
• Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening, e.g. hip replacement.
• Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study.
• Serious Sleep Apnea Hypopnea Syndrome (i.e. the scoring of question 15 in Parkinson's Disease Sleep Scale 2nd version (PDSS-2)≥ 3, that means frequency is at least 4 to 5 days during the past week )
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
• Serum levels of Aspartate Aminotransferase (AST)(SGOT), Alanine Aminotransferase (ALT)(SGPT), alkaline phosphatases or total bilirubin \>2 ULN (on screening lab test).
• Patients with a creatinine clearance \< 50 mL/min (estimated by the local lab / the investigator using the Modification of Diet in Renal Disease (MDRD, please refer to Appendix 10.1), and calculated on screening lab test).
• Any hypnotic medication within 4 weeks prior to the randomization visit (i.e. diazepam, clonazepam, estazolam, alprazolam, zolpidem, etc.).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Beijing Hospital

Beijing, 100730, China

Location

West China Hospital

Chengdu, 610041, China

Location

The First Afiliated Hospital, Sun Yet-sen University

Guangzhou, 510080, China

Location

2nd Affiliated Hosp Zhejiang University College of Medical

Hangzhou, 310009, China

Location

Brain Hospital Affiliated to Nanjing Med University

Nanjing, 210029, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

The First Hospital of Chinese Medical University

Shenyang, 110001, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, 215004, China

Location

Tianjin Medical University General Hospital

Tianjin, 30052, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

First Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710061, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

According to the study results, the decision was made to stop transitioning to Stage II. Therefore, only results of Stage I were reported.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 11, 2018
• Study Start: July 3, 2018
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-02

Locations

CN (12)