Trial Outcomes & Findings for An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001 (NCT NCT00199381)
NCT ID: NCT00199381
Last Updated: 2024-05-17
Results Overview
Investigation of the long-term tolerability and safety of istradefylline
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
Every 2 months up to 32 months
Results posted on
2024-05-17
Participant Flow
73 study centers in the US and Canada recruited subjects from the initiation date (28 October 2005). Patients who had previously participated in Study 6002-INT-001 were eligible to participate in this follow-on safety study,and hence had been taking istradefylline for at least a year.
Subjects completing 6002-INT-001 immediately before entering the study had an interruption of study drug of 30 days or less. Qualifying subjects with an interruption of more than 30 days had their baseline visit after laboratory tests results were reviewed by the Investigator.
Participant milestones
| Measure |
Single Arm
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Overall Study
STARTED
|
504
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
504
|
Reasons for withdrawal
| Measure |
Single Arm
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
38
|
|
Overall Study
Adverse Event
|
73
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lack of Efficacy
|
27
|
|
Overall Study
Not including due to early termination
|
37
|
|
Overall Study
Study termination by Sponsor
|
323
|
Baseline Characteristics
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Baseline characteristics by cohort
| Measure |
Single Arm
n=503 Participants
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
244 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
259 Participants
n=5 Participants
|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
348 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
401 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 months up to 32 monthsPopulation: Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set.
Investigation of the long-term tolerability and safety of istradefylline
Outcome measures
| Measure |
Single Arm
n=503 Participants
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Safety as Measured by Adverse Events
|
477 participants
|
Adverse Events
Single Arm
Serious events: 201 serious events
Other events: 276 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=503 participants at risk
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Nervous system disorders
Parkinson's disease
|
10.1%
51/503 • Number of events 55 • Dosing to end of treatment.
|
|
Nervous system disorders
Syncope
|
1.6%
8/503 • Number of events 8 • Dosing to end of treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Nervous system disorders
Convulsion
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Nervous system disorders
Lightheadedness
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Nervous system disorders
Somnolence
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.40%
2/503 • Number of events 3 • Dosing to end of treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Cervical myelopathy
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Dementia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Dyskinesia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Headache
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.20%
1/503 • Number of events 2 • Dosing to end of treatment.
|
|
Nervous system disorders
Myasthenia gravis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Myelopathy
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Paraparesis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Nervous system disorders
Tremor
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Localised osteoarthritis
|
1.2%
6/503 • Number of events 6 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
6/503 • Number of events 6 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.99%
5/503 • Number of events 5 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.99%
5/503 • Number of events 7 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
3/503 • Number of events 4 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylosis
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extemity
|
0.20%
1/503 • Number of events 2 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Accident
|
1.8%
9/503 • Number of events 9 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
8/503 • Number of events 8 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Closed head injury
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Injury
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
8/503 • Number of events 8 • Dosing to end of treatment.
|
|
Infections and infestations
Cellulitis
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.80%
4/503 • Number of events 5 • Dosing to end of treatment.
|
|
Infections and infestations
Postoperative infection
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Infections and infestations
Urosepsis
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Infections and infestations
Abscess jaw
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Abscess limb
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Diverticultis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Infection
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Labyrinthitis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Lobar pneumonia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Localised infection
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Sepsis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Infections and infestations
Viral infection
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Psychiatric disorders
Confusional state
|
2.0%
10/503 • Number of events 11 • Dosing to end of treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.99%
5/503 • Number of events 5 • Dosing to end of treatment.
|
|
Psychiatric disorders
Delirium
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Psychiatric disorders
Hallucination
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Psychiatric disorders
Agitation
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Psychiatric disorders
Delusion
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Psychiatric disorders
Depression
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Psychiatric disorders
Hallucination, visual
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Psychiatric disorders
Markedly reduced dietary intake
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
6/503 • Number of events 6 • Dosing to end of treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.99%
5/503 • Number of events 5 • Dosing to end of treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
3/503 • Number of events 4 • Dosing to end of treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Cardiomegaly
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Sinus arrest
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.40%
2/503 • Number of events 3 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.20%
1/503 • Number of events 2 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
3/503 • Number of events 4 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress snydrome
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Asthenia
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
General disorders
Chest pain
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
General disorders
Pyrexia
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
General disorders
Death
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Drug interaction
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Gait abnormal
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Generalised oedema
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Injection site haemorrhage
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.60%
3/503 • Number of events 3 • Dosing to end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.80%
4/503 • Number of events 4 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Colpocele
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.20%
1/503 • Number of events 2 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Vascular disorders
Hypotension
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Vascular disorders
Hypertension
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Vascular disorders
Malignant hypertension
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Renal and urinary disorders
Renal insufficiency
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
2/503 • Number of events 4 • Dosing to end of treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
2/503 • Number of events 2 • Dosing to end of treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.40%
2/503 • Number of events 3 • Dosing to end of treatment.
|
|
Surgical and medical procedures
Cardiac pacemaker revision
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Surgical and medical procedures
Medical device removal
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Eye disorders
Retinal detachment
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Hepatobiliary disorders
Gangrenous cholecystitis
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Investigations
Weight decreased
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/503 • Number of events 1 • Dosing to end of treatment.
|
Other adverse events
| Measure |
Single Arm
n=503 participants at risk
Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.8%
29/503 • Dosing to end of treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
36/503 • Dosing to end of treatment.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
47/503 • Dosing to end of treatment.
|
|
Injury, poisoning and procedural complications
Accident
|
20.3%
102/503 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
63/503 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
46/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Parkinson's disease
|
30.0%
151/503 • Dosing to end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
9.7%
49/503 • Dosing to end of treatment.
|
|
General disorders
Nausea
|
5.4%
27/503 • Dosing to end of treatment.
|
|
General disorders
Asthenia
|
5.8%
29/503 • Dosing to end of treatment.
|
|
Cardiac disorders
Oedema peripheral
|
8.2%
41/503 • Dosing to end of treatment.
|
|
Investigations
Weight decreased
|
7.0%
35/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Balance disorder
|
7.6%
38/503 • Dosing to end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
36/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Dyskinesia
|
27.0%
136/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Freezing phenomenon
|
6.4%
32/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Lightheadedness
|
6.6%
33/503 • Dosing to end of treatment.
|
|
Psychiatric disorders
Anxiety
|
8.0%
40/503 • Dosing to end of treatment.
|
|
Psychiatric disorders
Confusional state
|
5.8%
29/503 • Dosing to end of treatment.
|
|
Psychiatric disorders
Depression
|
10.7%
54/503 • Dosing to end of treatment.
|
|
Psychiatric disorders
Hallucination
|
13.7%
69/503 • Dosing to end of treatment.
|
|
Psychiatric disorders
Insomnia
|
9.7%
49/503 • Dosing to end of treatment.
|
|
General disorders
Fatigue
|
5.0%
25/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Headache
|
5.2%
26/503 • Dosing to end of treatment.
|
|
Nervous system disorders
Tremor
|
7.0%
35/503 • Dosing to end of treatment.
|
Additional Information
Director of Clinical Trials
Kyowa Hakko Kirin Pharma, Inc.
Phone: 609-919-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place