Trial Outcomes & Findings for An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease (NCT NCT00632736)
NCT ID: NCT00632736
Last Updated: 2017-03-23
Results Overview
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
419 participants
Primary outcome timeframe
13 February 2004 through 31 March 2010
Results posted on
2017-03-23
Participant Flow
Study 101468/248 (this study, NCT00632736) was an open-label extension study with ropinirole extended release (XL) for subjects from studies 101468/165, 101468/168, and 101468/169 (NCT00381472).
Participant milestones
| Measure |
Ropinirole XL
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Overall Study
STARTED
|
419
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
268
|
Reasons for withdrawal
| Measure |
Ropinirole XL
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Overall Study
Adverse Event
|
104
|
|
Overall Study
Lost to Follow-up
|
15
|
|
Overall Study
Protocol Violation
|
14
|
|
Overall Study
Withdrawal by Subject
|
99
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Sponsor terminated study
|
5
|
|
Overall Study
Non-compliance
|
10
|
|
Overall Study
Other
|
16
|
Baseline Characteristics
An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
Baseline characteristics by cohort
| Measure |
Ropinirole XL
n=419 Participants
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
259 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
409 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East & South East Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.5 kilograms per square meters (kg/m^2)
STANDARD_DEVIATION 4.48 • n=5 Participants
|
PRIMARY outcome
Timeframe: 13 February 2004 through 31 March 2010Population: Safety Population: all participants who received at least one dose of study medication
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
Outcome measures
| Measure |
Ropinirole XL
n=419 Participants
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Par. with drug-related AEs
|
213 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Par. with AEs leading to withdrawal
|
106 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants (Par.) reporting at least one AE
|
365 participants
|
|
Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Par. reporting at least one SAE
|
109 participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 26Population: All participants enrolled into this study from parent study 101468/168 who received at least one dose of study medication. Only 74 participants completed this questionnaire at Week 4, whereas 87 participants completed this questionnaire at Week 26.
The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: "Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day." Wk, Week.
Outcome measures
| Measure |
Ropinirole XL
n=112 Participants
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Both regimens are about the same, Week 4, n=74
|
5 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Preferred once a day, Week 26, n=87
|
14 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Very much preferred three times a day, Wk 4, n=74
|
2 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Much preferred three times a day, Week 4, n=74
|
0 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Preferred three times a day, Week 4, n=74
|
4 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Preferred once a day, Week 4, n=74
|
17 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Much preferred once a day, Week 4, n=74
|
18 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Very much preferred once a day, Week 4, n=74
|
28 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Very much preferred three times a day, Wk 26, n=87
|
4 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Much preferred three times a day, Week 26, n=87
|
1 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Preferred three times a day, Week 26, n=87
|
2 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Both regimens are about the same, Week 26, n=87
|
4 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Much preferred once a day, Week 26, n=87
|
20 participants
|
|
Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26
Very much preferred once a day, Week 26, n=87
|
42 participants
|
Adverse Events
Ropinirole XL
Serious events: 109 serious events
Other events: 261 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ropinirole XL
n=419 participants at risk
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Nervous system disorders
Parkinson's Disease
|
2.9%
12/419
|
|
Nervous system disorders
Dyskinesia
|
0.72%
3/419
|
|
Nervous system disorders
Sciatica
|
0.48%
2/419
|
|
Nervous system disorders
Akinesia
|
0.24%
1/419
|
|
Nervous system disorders
Balance disorder
|
0.24%
1/419
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.24%
1/419
|
|
Nervous system disorders
Cerebrovascular spasm
|
0.24%
1/419
|
|
Nervous system disorders
Dementia
|
0.24%
1/419
|
|
Nervous system disorders
Hypokinesia
|
0.24%
1/419
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.24%
1/419
|
|
Nervous system disorders
Radicular syndrome
|
0.24%
1/419
|
|
Nervous system disorders
Syncope
|
0.24%
1/419
|
|
Infections and infestations
Pneumonia
|
1.7%
7/419
|
|
Infections and infestations
Gastroenteritis
|
0.48%
2/419
|
|
Infections and infestations
Urinary tract infection
|
0.48%
2/419
|
|
Infections and infestations
Acute tonsillitis
|
0.24%
1/419
|
|
Infections and infestations
Appendicitis
|
0.24%
1/419
|
|
Infections and infestations
Bronchitis
|
0.24%
1/419
|
|
Infections and infestations
Bronchopneumonia
|
0.24%
1/419
|
|
Infections and infestations
Device related infection
|
0.24%
1/419
|
|
Infections and infestations
Diverticulitis
|
0.24%
1/419
|
|
Infections and infestations
Erysipelas
|
0.24%
1/419
|
|
Infections and infestations
Localised infection
|
0.24%
1/419
|
|
Infections and infestations
Necrotising fasciitis
|
0.24%
1/419
|
|
Infections and infestations
Pneumonia streptococcal
|
0.24%
1/419
|
|
Infections and infestations
Staphylococcal sepsis
|
0.24%
1/419
|
|
Infections and infestations
Viral infection
|
0.24%
1/419
|
|
Infections and infestations
Staphylococcal infection
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
3/419
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.48%
2/419
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.48%
2/419
|
|
Injury, poisoning and procedural complications
Contusion
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Post-procedural complication
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.24%
1/419
|
|
Injury, poisoning and procedural complications
Wound
|
0.24%
1/419
|
|
Cardiac disorders
Angina pectoris
|
1.2%
5/419
|
|
Cardiac disorders
Coronary artery disease
|
0.95%
4/419
|
|
Cardiac disorders
Arrhythmia
|
0.48%
2/419
|
|
Cardiac disorders
Atrial fibrillation
|
0.24%
1/419
|
|
Cardiac disorders
Atrial flutter
|
0.24%
1/419
|
|
Cardiac disorders
Bradycardia
|
0.24%
1/419
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.24%
1/419
|
|
Cardiac disorders
Mitral valve incompetence
|
0.24%
1/419
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
1/419
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
4/419
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.72%
3/419
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.24%
1/419
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.24%
1/419
|
|
Psychiatric disorders
Hallucination
|
0.48%
2/419
|
|
Psychiatric disorders
Psychotic disorder
|
0.72%
3/419
|
|
Psychiatric disorders
Anxiety
|
0.24%
1/419
|
|
Psychiatric disorders
Confusional state
|
0.24%
1/419
|
|
Psychiatric disorders
Delirium
|
0.24%
1/419
|
|
Psychiatric disorders
Depression
|
0.24%
1/419
|
|
Psychiatric disorders
Hallucination, auditory
|
0.24%
1/419
|
|
Psychiatric disorders
Hallucination, visual
|
0.24%
1/419
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.24%
1/419
|
|
Psychiatric disorders
Paranoia
|
0.24%
1/419
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.48%
2/419
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
1/419
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.24%
1/419
|
|
Gastrointestinal disorders
Diarrhoea
|
0.24%
1/419
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.24%
1/419
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.24%
1/419
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.24%
1/419
|
|
Gastrointestinal disorders
Ileus
|
0.24%
1/419
|
|
Gastrointestinal disorders
Peritonitis
|
0.24%
1/419
|
|
General disorders
Non-cardiac chest pain
|
0.48%
2/419
|
|
General disorders
Death
|
0.48%
2/419
|
|
General disorders
Chest pain
|
0.24%
1/419
|
|
General disorders
Device breakage
|
0.24%
1/419
|
|
General disorders
Device dislocation
|
0.24%
1/419
|
|
General disorders
Gait disturbance
|
0.24%
1/419
|
|
General disorders
Malaise
|
0.24%
1/419
|
|
General disorders
Multi-organ failure
|
0.24%
1/419
|
|
General disorders
Sudden death
|
0.48%
2/419
|
|
Vascular disorders
Hypertensive crisis
|
0.48%
2/419
|
|
Vascular disorders
Aortic aneurysm
|
0.24%
1/419
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.24%
1/419
|
|
Vascular disorders
Deep vein thrombosis
|
0.24%
1/419
|
|
Vascular disorders
Hypertension
|
0.24%
1/419
|
|
Vascular disorders
Hypotension
|
0.24%
1/419
|
|
Vascular disorders
Lymphoedema
|
0.24%
1/419
|
|
Vascular disorders
Thrombophlebitis
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.24%
1/419
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.24%
1/419
|
|
Renal and urinary disorders
Urinary retention
|
0.72%
3/419
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.24%
1/419
|
|
Renal and urinary disorders
Calculus bladder
|
0.24%
1/419
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.24%
1/419
|
|
Renal and urinary disorders
Haematuria
|
0.24%
1/419
|
|
Renal and urinary disorders
Renal failure chronic
|
0.24%
1/419
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
2/419
|
|
Hepatobiliary disorders
Bile duct stone
|
0.24%
1/419
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.48%
2/419
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/419
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/419
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.48%
2/419
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.24%
1/419
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.48%
2/419
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.24%
1/419
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
1/419
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.24%
1/419
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
1/419
|
|
Investigations
Blood pressure increased
|
0.24%
1/419
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.24%
1/419
|
Other adverse events
| Measure |
Ropinirole XL
n=419 participants at risk
Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.
|
|---|---|
|
Nervous system disorders
Somnolence
|
11.2%
47/419
|
|
Nervous system disorders
Dyskinesia
|
8.4%
35/419
|
|
Nervous system disorders
Headache
|
6.4%
27/419
|
|
Nervous system disorders
Dizziness
|
5.5%
23/419
|
|
Nervous system disorders
Parkinson's Disease
|
5.5%
23/419
|
|
Psychiatric disorders
Hallucination
|
12.9%
54/419
|
|
Psychiatric disorders
Insomnia
|
7.4%
31/419
|
|
Psychiatric disorders
Depression
|
5.0%
21/419
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
58/419
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
22/419
|
|
Infections and infestations
Influenza
|
5.5%
23/419
|
|
General disorders
Oedema peripheral
|
11.5%
48/419
|
|
Gastrointestinal disorders
Nausea
|
6.4%
27/419
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
22/419
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER