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NET-PD LS-1 Creatine in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00449865
Recruitment Status : Terminated (Futility)
First Posted : March 21, 2007
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Karl Kieburtz, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: creatine
Other: placebo
Enrollment 1741
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Creatine
Hide Arm/Group Description placebo: an inactive substance creatine monohydrate (10 gram /day)
Period Title: Overall Study
Started 867 874
Completed Year 1 802 [1] 822 [2]
Completed Year 2 768 [3] 766 [4]
Completed Year 3 719 [5] 715 [6]
Completed Year 4 521 [7] 523 [8]
Completed 345 [9] 340 [10]
Not Completed 522 534
Reason Not Completed
Withdrawal by Subject             110             110
Lost to Follow-up             36             37
Physician Decision             13             12
Death             31             40
Protocol Violation             8             7
Study was stopped             324             328
[1]
867 Expected at Year 1
[2]
874 Expected at Year 1
[3]
867 Expected at Year 2
[4]
874 Expected at Year 2
[5]
867 Expected at Year 3
[6]
874 Expected at Year 3
[7]
679 Expected at Year 4
[8]
686 Expected at Year 4
[9]
478 Expected at Year 5
[10]
477 Expected at Year 5
Arm/Group Title Placebo Creatine Total
Hide Arm/Group Description placebo: an inactive substance creatine 5 grams twice daily Total of all reporting groups
Overall Number of Baseline Participants 867 874 1741
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 867 participants 874 participants 1741 participants
61.5  (9.6) 62.1  (9.7) 61.8  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 867 participants 874 participants 1741 participants
Female
313
  36.1%
305
  34.9%
618
  35.5%
Male
554
  63.9%
569
  65.1%
1123
  64.5%
Time since diagnosis, y  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 867 participants 874 participants 1741 participants
1.6  (1.1) 1.5  (1.1) 1.5  (1.1)
Total Unified Parkinson's Disease Rating Scale (UPDRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 867 participants 874 participants 1741 participants
25.9  (11) 26.5  (11.7) 26.2  (11.4)
[1]
Measure Description: The total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.
1.Primary Outcome
Title The Global Outcome Combined Information on Change From Baseline in Schwab England Activities of Daily Living, 39-Item Parkinson's Disease Questionnaire, Ambulatory Capacity, Symbol Digit Modalities, and Modified Rankin at 5 Years.
Hide Description All outcomes were coded such that higher scores indicated worse outcomes. Patients were ranked on each outcome and their ranks were summed (summed-ranks). Higher summed ranks (range, 5-4775) indicate worse outcomes. The mean summed ranks were compared by treatment group by a global statistical test (GST).
Time Frame Change from baseline to 5 YEARS
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat sample: n = 955, participants randomized at least 5 years before July 2013 (time of planned interim analysis).
Arm/Group Title Placebo Creatine
Hide Arm/Group Description:
placebo: an inactive substance
creatine monohydrate (10 grams/day)
Overall Number of Participants Analyzed 478 477
Mean (95% Confidence Interval)
Unit of Measure: summed-ranks
2360
(2249 to 2470)
2414
(2304 to 2524)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Creatine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Global Statistical Test
Comments The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Creatine
Hide Arm/Group Description placebo: an inactive substance creatine 5 grams twice daily
All-Cause Mortality
Placebo Creatine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Creatine
Affected / at Risk (%) Affected / at Risk (%)
Total   347/867 (40.02%)   315/874 (36.04%) 
Blood and lymphatic system disorders     
Anaemia  0/867 (0.00%)  1/874 (0.11%) 
Haemolytic anaemia  1/867 (0.12%)  0/874 (0.00%) 
Cardiac disorders     
Angina pectoris  1/867 (0.12%)  2/874 (0.23%) 
Angina unstable  1/867 (0.12%)  1/874 (0.11%) 
Aortic valve disease  1/867 (0.12%)  0/874 (0.00%) 
Aortic valve incompetence  1/867 (0.12%)  0/874 (0.00%) 
Atrial fibrillation  4/867 (0.46%)  9/874 (1.03%) 
Bradycardia  4/867 (0.46%)  0/874 (0.00%) 
Brugada syndrome  0/867 (0.00%)  1/874 (0.11%) 
Cardiac arrest  4/867 (0.46%)  7/874 (0.80%) 
Cardiac disorder  1/867 (0.12%)  0/874 (0.00%) 
Cardiac failure  1/867 (0.12%)  0/874 (0.00%) 
Cardiac failure congestive  1/867 (0.12%)  3/874 (0.34%) 
Cardio-respiratory arrest  1/867 (0.12%)  3/874 (0.34%) 
Cardiopulmonary failure  1/867 (0.12%)  0/874 (0.00%) 
Coronary artery disease  3/867 (0.35%)  4/874 (0.46%) 
Coronary artery occlusion  1/867 (0.12%)  0/874 (0.00%) 
Coronary artery stenosis  1/867 (0.12%)  1/874 (0.11%) 
Diastolic dysfunction  1/867 (0.12%)  0/874 (0.00%) 
Hypertensive heart disease  1/867 (0.12%)  0/874 (0.00%) 
Mitral valve stenosis  0/867 (0.00%)  1/874 (0.11%) 
Myocardial infarction  8/867 (0.92%)  12/874 (1.37%) 
Myocardial ischaemia  0/867 (0.00%)  2/874 (0.23%) 
Palpitations  1/867 (0.12%)  0/874 (0.00%) 
Sick sinus syndrome  0/867 (0.00%)  1/874 (0.11%) 
Ventricular fibrillation  1/867 (0.12%)  0/874 (0.00%) 
Ventricular tachycardia  0/867 (0.00%)  1/874 (0.11%) 
Congenital, familial and genetic disorders     
Congenital coronary artery malformation  1/867 (0.12%)  0/874 (0.00%) 
Factor V deficiency  0/867 (0.00%)  1/874 (0.11%) 
Ear and labyrinth disorders     
Vertigo  4/867 (0.46%)  1/874 (0.11%) 
Vertigo positional  0/867 (0.00%)  1/874 (0.11%) 
Endocrine disorders     
Goitre  2/867 (0.23%)  0/874 (0.00%) 
Hyperparathyroidism  1/867 (0.12%)  0/874 (0.00%) 
Eye disorders     
Amaurosis fugax  0/867 (0.00%)  1/874 (0.11%) 
Blindness transient  0/867 (0.00%)  1/874 (0.11%) 
Macular oedema  1/867 (0.12%)  0/874 (0.00%) 
Gastrointestinal disorders     
Abdominal adhesions  1/867 (0.12%)  0/874 (0.00%) 
Abdominal hernia  0/867 (0.00%)  2/874 (0.23%) 
Abdominal pain  2/867 (0.23%)  2/874 (0.23%) 
Abdominal pain upper  1/867 (0.12%)  0/874 (0.00%) 
Anal fissure  0/867 (0.00%)  1/874 (0.11%) 
Ascites  0/867 (0.00%)  1/874 (0.11%) 
Colitis  0/867 (0.00%)  1/874 (0.11%) 
Colitis ischaemic  0/867 (0.00%)  3/874 (0.34%) 
Constipation  1/867 (0.12%)  1/874 (0.11%) 
Diarrhoea  2/867 (0.23%)  1/874 (0.11%) 
Dyspepsia  1/867 (0.12%)  0/874 (0.00%) 
Dysphagia  1/867 (0.12%)  0/874 (0.00%) 
Faecaloma  1/867 (0.12%)  0/874 (0.00%) 
Gastrointestinal haemorrhage  2/867 (0.23%)  1/874 (0.11%) 
Hiatus hernia  0/867 (0.00%)  1/874 (0.11%) 
Ileus  1/867 (0.12%)  2/874 (0.23%) 
Impaired gastric emptying  0/867 (0.00%)  1/874 (0.11%) 
Inguinal hernia  1/867 (0.12%)  1/874 (0.11%) 
Intestinal obstruction  3/867 (0.35%)  6/874 (0.69%) 
Nausea  2/867 (0.23%)  0/874 (0.00%) 
Oesophageal achalasia  0/867 (0.00%)  2/874 (0.23%) 
Oesophageal stenosis  0/867 (0.00%)  1/874 (0.11%) 
Oesophageal ulcer haemorrhage  0/867 (0.00%)  1/874 (0.11%) 
Pharyngoesophageal diverticulum  0/867 (0.00%)  1/874 (0.11%) 
Rectal haemorrhage  0/867 (0.00%)  1/874 (0.11%) 
Small intestinal obstruction  2/867 (0.23%)  3/874 (0.34%) 
Upper gastrointestinal haemorrhage  1/867 (0.12%)  2/874 (0.23%) 
Vomiting  3/867 (0.35%)  0/874 (0.00%) 
General disorders     
Adverse drug reaction  0/867 (0.00%)  1/874 (0.11%) 
Asthenia  5/867 (0.58%)  2/874 (0.23%) 
Chest discomfort  2/867 (0.23%)  0/874 (0.00%) 
Chest pain  15/867 (1.73%)  14/874 (1.60%) 
Cyst  0/867 (0.00%)  2/874 (0.23%) 
Death  2/867 (0.23%)  5/874 (0.57%) 
Drug interaction  1/867 (0.12%)  0/874 (0.00%) 
Facial pain  0/867 (0.00%)  1/874 (0.11%) 
Fatigue  0/867 (0.00%)  1/874 (0.11%) 
Gait disturbance  1/867 (0.12%)  0/874 (0.00%) 
Medical device complication  1/867 (0.12%)  0/874 (0.00%) 
Non-cardiac chest pain  2/867 (0.23%)  2/874 (0.23%) 
Pain  9/867 (1.04%)  4/874 (0.46%) 
Ulcer  2/867 (0.23%)  1/874 (0.11%) 
Hepatobiliary disorders     
Bile duct stone  0/867 (0.00%)  1/874 (0.11%) 
Cholangitis  0/867 (0.00%)  1/874 (0.11%) 
Cholecystitis  2/867 (0.23%)  3/874 (0.34%) 
Cholelithiasis  0/867 (0.00%)  3/874 (0.34%) 
Gallbladder disorder  1/867 (0.12%)  0/874 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1/867 (0.12%)  1/874 (0.11%) 
Infections and infestations     
Abscess  0/867 (0.00%)  1/874 (0.11%) 
Appendicitis  4/867 (0.46%)  1/874 (0.11%) 
Appendicitis perforated  0/867 (0.00%)  1/874 (0.11%) 
Bacterial infection  1/867 (0.12%)  0/874 (0.00%) 
Bronchitis  1/867 (0.12%)  1/874 (0.11%) 
Cellulitis  4/867 (0.46%)  4/874 (0.46%) 
Clostridial infection  1/867 (0.12%)  1/874 (0.11%) 
Clostridium difficile colitis  0/867 (0.00%)  1/874 (0.11%) 
Coccidioidomycosis  1/867 (0.12%)  0/874 (0.00%) 
Creutzfeldt-Jakob disease  1/867 (0.12%)  0/874 (0.00%) 
Cystitis  1/867 (0.12%)  1/874 (0.11%) 
Cytomegalovirus infection  0/867 (0.00%)  1/874 (0.11%) 
Diverticulitis  2/867 (0.23%)  3/874 (0.34%) 
Gastroenteritis  2/867 (0.23%)  0/874 (0.00%) 
Groin abscess  0/867 (0.00%)  1/874 (0.11%) 
Herpes zoster  1/867 (0.12%)  0/874 (0.00%) 
Hip infection  1/867 (0.12%)  0/874 (0.00%) 
Infection  1/867 (0.12%)  4/874 (0.46%) 
Influenza  1/867 (0.12%)  1/874 (0.11%) 
Intervertebral discitis  1/867 (0.12%)  0/874 (0.00%) 
Kidney infection  1/867 (0.12%)  1/874 (0.11%) 
Labyrinthitis  1/867 (0.12%)  0/874 (0.00%) 
Liver abscess  1/867 (0.12%)  0/874 (0.00%) 
Lung infection  0/867 (0.00%)  1/874 (0.11%) 
Meningitis bacterial  1/867 (0.12%)  0/874 (0.00%) 
Meningitis viral  1/867 (0.12%)  0/874 (0.00%) 
Oesophageal infection  1/867 (0.12%)  0/874 (0.00%) 
Osteomyelitis  1/867 (0.12%)  0/874 (0.00%) 
Peridiverticulitis  0/867 (0.00%)  1/874 (0.11%) 
Pharyngitis  1/867 (0.12%)  0/874 (0.00%) 
Pneumonia  18/867 (2.08%)  16/874 (1.83%) 
Pyelonephritis  1/867 (0.12%)  1/874 (0.11%) 
Sepsis  1/867 (0.12%)  1/874 (0.11%) 
Septic shock  1/867 (0.12%)  0/874 (0.00%) 
Sinusitis  1/867 (0.12%)  0/874 (0.00%) 
Staphylococcal infection  2/867 (0.23%)  0/874 (0.00%) 
Urinary tract infection  9/867 (1.04%)  5/874 (0.57%) 
Urosepsis  4/867 (0.46%)  0/874 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1/867 (0.12%)  1/874 (0.11%) 
Arterial injury  0/867 (0.00%)  1/874 (0.11%) 
Avulsion fracture  0/867 (0.00%)  1/874 (0.11%) 
Cervical vertebral fracture  1/867 (0.12%)  0/874 (0.00%) 
Clavicle fracture  0/867 (0.00%)  1/874 (0.11%) 
Concussion  1/867 (0.12%)  1/874 (0.11%) 
Contusion  2/867 (0.23%)  0/874 (0.00%) 
Fall  11/867 (1.27%)  7/874 (0.80%) 
Femoral neck fracture  1/867 (0.12%)  0/874 (0.00%) 
Femur fracture  5/867 (0.58%)  3/874 (0.34%) 
Fibula fracture  1/867 (0.12%)  1/874 (0.11%) 
Forearm fracture  1/867 (0.12%)  0/874 (0.00%) 
Foreign body  1/867 (0.12%)  0/874 (0.00%) 
Fracture  1/867 (0.12%)  1/874 (0.11%) 
Hand fracture  0/867 (0.00%)  1/874 (0.11%) 
Heat exhaustion  0/867 (0.00%)  1/874 (0.11%) 
Hip fracture  12/867 (1.38%)  10/874 (1.14%) 
Humerus fracture  2/867 (0.23%)  0/874 (0.00%) 
Injury  1/867 (0.12%)  0/874 (0.00%) 
Joint sprain  0/867 (0.00%)  1/874 (0.11%) 
Laceration  4/867 (0.46%)  1/874 (0.11%) 
Ligament rupture  0/867 (0.00%)  1/874 (0.11%) 
Limb crushing injury  1/867 (0.12%)  0/874 (0.00%) 
Limb injury  1/867 (0.12%)  0/874 (0.00%) 
Lower limb fracture  1/867 (0.12%)  0/874 (0.00%) 
Lumbar vertebral fracture  0/867 (0.00%)  1/874 (0.11%) 
Meniscus lesion  0/867 (0.00%)  1/874 (0.11%) 
Overdose  0/867 (0.00%)  1/874 (0.11%) 
Pelvic fracture  2/867 (0.23%)  1/874 (0.11%) 
Periorbital haematoma  1/867 (0.12%)  0/874 (0.00%) 
Rib fracture  4/867 (0.46%)  2/874 (0.23%) 
Road traffic accident  1/867 (0.12%)  1/874 (0.11%) 
Spinal compression fracture  1/867 (0.12%)  0/874 (0.00%) 
Sternal fracture  0/867 (0.00%)  1/874 (0.11%) 
Stress fracture  0/867 (0.00%)  1/874 (0.11%) 
Subdural haematoma  3/867 (0.35%)  2/874 (0.23%) 
Subdural haemorrhage  1/867 (0.12%)  0/874 (0.00%) 
Tendon injury  2/867 (0.23%)  0/874 (0.00%) 
Tendon rupture  0/867 (0.00%)  1/874 (0.11%) 
Thoracic vertebral fracture  0/867 (0.00%)  1/874 (0.11%) 
Tibia fracture  1/867 (0.12%)  3/874 (0.34%) 
Ulna fracture  1/867 (0.12%)  0/874 (0.00%) 
Upper limb fracture  1/867 (0.12%)  0/874 (0.00%) 
Investigations     
Blood sodium decreased  0/867 (0.00%)  1/874 (0.11%) 
Catheterisation cardiac  1/867 (0.12%)  0/874 (0.00%) 
Heart rate irregular  1/867 (0.12%)  1/874 (0.11%) 
Hepatic enzyme increased  1/867 (0.12%)  0/874 (0.00%) 
Investigation  0/867 (0.00%)  1/874 (0.11%) 
Medical observation  0/867 (0.00%)  1/874 (0.11%) 
Prostatic specific antigen increased  0/867 (0.00%)  1/874 (0.11%) 
Weight decreased  2/867 (0.23%)  0/874 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  2/867 (0.23%)  2/874 (0.23%) 
Diabetes mellitus  1/867 (0.12%)  0/874 (0.00%) 
Failure to thrive  0/867 (0.00%)  1/874 (0.11%) 
Hypercalcaemia  0/867 (0.00%)  1/874 (0.11%) 
Hypokalaemia  2/867 (0.23%)  0/874 (0.00%) 
Hyponatraemia  1/867 (0.12%)  1/874 (0.11%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  7/867 (0.81%)  3/874 (0.34%) 
Arthritis  6/867 (0.69%)  13/874 (1.49%) 
Back pain  1/867 (0.12%)  3/874 (0.34%) 
Cervical spinal stenosis  1/867 (0.12%)  0/874 (0.00%) 
Exostosis  0/867 (0.00%)  1/874 (0.11%) 
Fall  1/867 (0.12%)  0/874 (0.00%) 
Intervertebral disc degeneration  2/867 (0.23%)  2/874 (0.23%) 
Intervertebral disc protrusion  9/867 (1.04%)  0/874 (0.00%) 
Joint instability  1/867 (0.12%)  0/874 (0.00%) 
Lumbar spinal stenosis  3/867 (0.35%)  11/874 (1.26%) 
Muscle contracture  1/867 (0.12%)  0/874 (0.00%) 
Musculoskeletal pain  1/867 (0.12%)  2/874 (0.23%) 
Musculoskeletal stiffness  1/867 (0.12%)  0/874 (0.00%) 
Osteoarthritis  16/867 (1.85%)  15/874 (1.72%) 
Rhabdomyolysis  2/867 (0.23%)  0/874 (0.00%) 
Rotator cuff syndrome  2/867 (0.23%)  1/874 (0.11%) 
Scoliosis  2/867 (0.23%)  1/874 (0.11%) 
Spinal column stenosis  11/867 (1.27%)  4/874 (0.46%) 
Spinal disorder  1/867 (0.12%)  0/874 (0.00%) 
Spinal osteoarthritis  2/867 (0.23%)  2/874 (0.23%) 
Spondylolisthesis  2/867 (0.23%)  2/874 (0.23%) 
Tendonitis  1/867 (0.12%)  0/874 (0.00%) 
Vertebral foraminal stenosis  1/867 (0.12%)  0/874 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1/867 (0.12%)  0/874 (0.00%) 
Benign neoplasm  0/867 (0.00%)  1/874 (0.11%) 
Bile duct cancer  0/867 (0.00%)  1/874 (0.11%) 
Bladder cancer  2/867 (0.23%)  1/874 (0.11%) 
Bladder cancer recurrent  1/867 (0.12%)  1/874 (0.11%) 
Bladder transitional cell carcinoma  1/867 (0.12%)  0/874 (0.00%) 
Brain neoplasm  0/867 (0.00%)  1/874 (0.11%) 
Breast cancer  2/867 (0.23%)  1/874 (0.11%) 
Breast cancer metastatic  1/867 (0.12%)  0/874 (0.00%) 
Carcinoid tumour of the pancreas  0/867 (0.00%)  1/874 (0.11%) 
Cervix carcinoma  1/867 (0.12%)  0/874 (0.00%) 
Chordoma  1/867 (0.12%)  0/874 (0.00%) 
Colon cancer  3/867 (0.35%)  1/874 (0.11%) 
Colorectal cancer  0/867 (0.00%)  1/874 (0.11%) 
Endometrial cancer  1/867 (0.12%)  0/874 (0.00%) 
Gastrointestinal stromal tumour  1/867 (0.12%)  0/874 (0.00%) 
Glioblastoma multiforme  1/867 (0.12%)  0/874 (0.00%) 
Hepatic neoplasm  0/867 (0.00%)  1/874 (0.11%) 
Hepatic neoplasm malignant  1/867 (0.12%)  0/874 (0.00%) 
Large cell carcinoma of the respiratory tract stage unspecified  1/867 (0.12%)  0/874 (0.00%) 
Leukaemia plasmacytic  1/867 (0.12%)  0/874 (0.00%) 
Lung cancer metastatic  2/867 (0.23%)  0/874 (0.00%) 
Lung neoplasm  1/867 (0.12%)  0/874 (0.00%) 
Lung neoplasm malignant  1/867 (0.12%)  1/874 (0.11%) 
Malignant melanoma  3/867 (0.35%)  0/874 (0.00%) 
Mantle cell lymphoma  1/867 (0.12%)  0/874 (0.00%) 
Metastases to meninges  0/867 (0.00%)  1/874 (0.11%) 
Metastasis  0/867 (0.00%)  1/874 (0.11%) 
Metastatic neoplasm  1/867 (0.12%)  0/874 (0.00%) 
Multiple myeloma  1/867 (0.12%)  0/874 (0.00%) 
Non-Hodgkin's lymphoma stage IV  1/867 (0.12%)  0/874 (0.00%) 
Ovarian cancer  0/867 (0.00%)  2/874 (0.23%) 
Pancreatic carcinoma  1/867 (0.12%)  1/874 (0.11%) 
Prostate cancer  3/867 (0.35%)  2/874 (0.23%) 
Rectal cancer  1/867 (0.12%)  0/874 (0.00%) 
Rectosigmoid cancer  0/867 (0.00%)  1/874 (0.11%) 
Renal cell carcinoma  3/867 (0.35%)  0/874 (0.00%) 
Small cell lung cancer stage unspecified  1/867 (0.12%)  0/874 (0.00%) 
Squamous cell carcinoma  2/867 (0.23%)  0/874 (0.00%) 
T-cell lymphoma  1/867 (0.12%)  0/874 (0.00%) 
Thyroid cancer  0/867 (0.00%)  1/874 (0.11%) 
Nervous system disorders     
Amyotrophic lateral sclerosis  0/867 (0.00%)  1/874 (0.11%) 
Carotid artery occlusion  0/867 (0.00%)  2/874 (0.23%) 
Carotid artery stenosis  0/867 (0.00%)  1/874 (0.11%) 
Cerebellar haemorrhage  0/867 (0.00%)  1/874 (0.11%) 
Cerebral haemorrhage  1/867 (0.12%)  0/874 (0.00%) 
Cerebral infarction  3/867 (0.35%)  0/874 (0.00%) 
Cerebrovascular accident  6/867 (0.69%)  6/874 (0.69%) 
Cognitive disorder  1/867 (0.12%)  0/874 (0.00%) 
Convulsion  0/867 (0.00%)  1/874 (0.11%) 
Dementia  1/867 (0.12%)  0/874 (0.00%) 
Dementia Alzheimer's type  1/867 (0.12%)  0/874 (0.00%) 
Dizziness  5/867 (0.58%)  1/874 (0.11%) 
Dysarthria  0/867 (0.00%)  1/874 (0.11%) 
Encephalopathy  0/867 (0.00%)  1/874 (0.11%) 
Epilepsy  1/867 (0.12%)  0/874 (0.00%) 
Facial palsy  1/867 (0.12%)  1/874 (0.11%) 
Grand mal convulsion  0/867 (0.00%)  1/874 (0.11%) 
Guillain-Barre syndrome  0/867 (0.00%)  1/874 (0.11%) 
Haemorrhagic stroke  2/867 (0.23%)  0/874 (0.00%) 
Headache  1/867 (0.12%)  0/874 (0.00%) 
Hypoaesthesia  1/867 (0.12%)  0/874 (0.00%) 
Intracranial hypotension  1/867 (0.12%)  0/874 (0.00%) 
Ischaemic stroke  2/867 (0.23%)  0/874 (0.00%) 
Lethargy  0/867 (0.00%)  1/874 (0.11%) 
Loss of consciousness  2/867 (0.23%)  3/874 (0.34%) 
Migraine  1/867 (0.12%)  1/874 (0.11%) 
Migraine with aura  0/867 (0.00%)  1/874 (0.11%) 
Motor dysfunction  0/867 (0.00%)  1/874 (0.11%) 
Multiple sclerosis relapse  1/867 (0.12%)  0/874 (0.00%) 
Nerve compression  1/867 (0.12%)  1/874 (0.11%) 
Neuropathy peripheral  1/867 (0.12%)  0/874 (0.00%) 
Parkinson's disease  4/867 (0.46%)  4/874 (0.46%) 
Presyncope  3/867 (0.35%)  2/874 (0.23%) 
Sciatica  1/867 (0.12%)  0/874 (0.00%) 
Spinal cord compression  1/867 (0.12%)  0/874 (0.00%) 
Spinal cord disorder  1/867 (0.12%)  0/874 (0.00%) 
Subarachnoid haemorrhage  2/867 (0.23%)  0/874 (0.00%) 
Syncope  15/867 (1.73%)  12/874 (1.37%) 
Transient ischaemic attack  6/867 (0.69%)  4/874 (0.46%) 
Tremor  2/867 (0.23%)  0/874 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1/867 (0.12%)  0/874 (0.00%) 
Psychiatric disorders     
Aggression  1/867 (0.12%)  0/874 (0.00%) 
Anxiety  3/867 (0.35%)  1/874 (0.11%) 
Confusional state  3/867 (0.35%)  2/874 (0.23%) 
Delusion  1/867 (0.12%)  1/874 (0.11%) 
Depression  2/867 (0.23%)  1/874 (0.11%) 
Disorientation  0/867 (0.00%)  1/874 (0.11%) 
Food aversion  1/867 (0.12%)  0/874 (0.00%) 
Hallucination  3/867 (0.35%)  3/874 (0.34%) 
Hallucination, visual  1/867 (0.12%)  0/874 (0.00%) 
Intentional self-injury  1/867 (0.12%)  0/874 (0.00%) 
Major depression  0/867 (0.00%)  1/874 (0.11%) 
Mania  1/867 (0.12%)  0/874 (0.00%) 
Mental disorder  2/867 (0.23%)  1/874 (0.11%) 
Mental status changes  1/867 (0.12%)  0/874 (0.00%) 
Panic attack  0/867 (0.00%)  1/874 (0.11%) 
Paranoia  1/867 (0.12%)  0/874 (0.00%) 
Psychotic disorder  1/867 (0.12%)  1/874 (0.11%) 
Suicidal ideation  0/867 (0.00%)  2/874 (0.23%) 
Renal and urinary disorders     
Bladder disorder  0/867 (0.00%)  1/874 (0.11%) 
Bladder prolapse  2/867 (0.23%)  3/874 (0.34%) 
Contracted bladder  0/867 (0.00%)  1/874 (0.11%) 
Nephrolithiasis  6/867 (0.69%)  2/874 (0.23%) 
Renal colic  2/867 (0.23%)  0/874 (0.00%) 
Renal failure  1/867 (0.12%)  0/874 (0.00%) 
Renal failure acute  1/867 (0.12%)  0/874 (0.00%) 
Ureteric stenosis  0/867 (0.00%)  1/874 (0.11%) 
Urinary incontinence  0/867 (0.00%)  1/874 (0.11%) 
Urinary retention  4/867 (0.46%)  1/874 (0.11%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  2/867 (0.23%)  3/874 (0.34%) 
Cystocele  2/867 (0.23%)  2/874 (0.23%) 
Epididymitis  0/867 (0.00%)  1/874 (0.11%) 
Joint dislocation  0/867 (0.00%)  1/874 (0.11%) 
Ovarian cyst  1/867 (0.12%)  0/874 (0.00%) 
Prostatitis  1/867 (0.12%)  1/874 (0.11%) 
Prostatomegaly  4/867 (0.46%)  0/874 (0.00%) 
Rectocele  1/867 (0.12%)  0/874 (0.00%) 
Uterine polyp  0/867 (0.00%)  1/874 (0.11%) 
Uterine prolapse  1/867 (0.12%)  0/874 (0.00%) 
Vaginal prolapse  1/867 (0.12%)  1/874 (0.11%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  0/867 (0.00%)  1/874 (0.11%) 
Atelectasis  1/867 (0.12%)  0/874 (0.00%) 
Chest Pain  0/867 (0.00%)  1/874 (0.11%) 
Chronic obstructive pulmonary disease  1/867 (0.12%)  0/874 (0.00%) 
Cough  1/867 (0.12%)  0/874 (0.00%) 
Dyspnoea  6/867 (0.69%)  2/874 (0.23%) 
Laryngospasm  1/867 (0.12%)  0/874 (0.00%) 
Pleural effusion  0/867 (0.00%)  2/874 (0.23%) 
Pneumonia aspiration  4/867 (0.46%)  2/874 (0.23%) 
Pneumothorax  2/867 (0.23%)  0/874 (0.00%) 
Pulmonary embolism  11/867 (1.27%)  7/874 (0.80%) 
Pulmonary interstitial emphysema syndrome  0/867 (0.00%)  1/874 (0.11%) 
Respiratory arrest  1/867 (0.12%)  0/874 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1/867 (0.12%)  1/874 (0.11%) 
Surgical and medical procedures     
Angioplasty  1/867 (0.12%)  0/874 (0.00%) 
Aortic valve replacement  3/867 (0.35%)  0/874 (0.00%) 
Appendicectomy  0/867 (0.00%)  1/874 (0.11%) 
Benign tumour excision  1/867 (0.12%)  0/874 (0.00%) 
Cardiac pacemaker insertion  0/867 (0.00%)  2/874 (0.23%) 
Cholecystectomy  0/867 (0.00%)  3/874 (0.34%) 
Colporrhaphy  0/867 (0.00%)  1/874 (0.11%) 
Deep brain stimulation  27/867 (3.11%)  24/874 (2.75%) 
Heart valve replacement  1/867 (0.12%)  0/874 (0.00%) 
Hernia hiatus repair  0/867 (0.00%)  1/874 (0.11%) 
Hernia repair  1/867 (0.12%)  1/874 (0.11%) 
Hip arthroplasty  5/867 (0.58%)  2/874 (0.23%) 
Hysterectomy  2/867 (0.23%)  3/874 (0.34%) 
Joint arthroplasty  1/867 (0.12%)  5/874 (0.57%) 
Knee arthroplasty  5/867 (0.58%)  3/874 (0.34%) 
Large intestine anastomosis  0/867 (0.00%)  1/874 (0.11%) 
Meniscus operation  0/867 (0.00%)  1/874 (0.11%) 
Mitral valve replacement  1/867 (0.12%)  0/874 (0.00%) 
Nephrectomy  1/867 (0.12%)  1/874 (0.11%) 
Prophylaxis of nausea and vomiting  0/867 (0.00%)  1/874 (0.11%) 
Prostatectomy  0/867 (0.00%)  1/874 (0.11%) 
Shoulder arthroplasty  0/867 (0.00%)  1/874 (0.11%) 
Spinal decompression  1/867 (0.12%)  0/874 (0.00%) 
Spinal fusion surgery  2/867 (0.23%)  3/874 (0.34%) 
Spinal laminectomy  1/867 (0.12%)  3/874 (0.34%) 
Stent placement  2/867 (0.23%)  2/874 (0.23%) 
Surgery  1/867 (0.12%)  2/874 (0.23%) 
Thalamotomy  1/867 (0.12%)  0/874 (0.00%) 
Thyroidectomy  1/867 (0.12%)  0/874 (0.00%) 
Tracheostomy  1/867 (0.12%)  0/874 (0.00%) 
Transurethral prostatectomy  1/867 (0.12%)  2/874 (0.23%) 
Vascular disorders     
Aneurysm  1/867 (0.12%)  0/874 (0.00%) 
Aortic aneurysm  3/867 (0.35%)  1/874 (0.11%) 
Aortic dissection  1/867 (0.12%)  0/874 (0.00%) 
Aortic occlusion  0/867 (0.00%)  1/874 (0.11%) 
Aortic stenosis  1/867 (0.12%)  0/874 (0.00%) 
Arterial stenosis  1/867 (0.12%)  0/874 (0.00%) 
Deep vein thrombosis  0/867 (0.00%)  6/874 (0.69%) 
Embolism  0/867 (0.00%)  1/874 (0.11%) 
Fibromuscular dysplasia  0/867 (0.00%)  1/874 (0.11%) 
Hypertension  4/867 (0.46%)  0/874 (0.00%) 
Hypertensive crisis  1/867 (0.12%)  0/874 (0.00%) 
Hypotension  3/867 (0.35%)  2/874 (0.23%) 
Orthostatic hypotension  2/867 (0.23%)  3/874 (0.34%) 
Thrombosis  1/867 (0.12%)  1/874 (0.11%) 
Venous thrombosis  0/867 (0.00%)  1/874 (0.11%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Creatine
Affected / at Risk (%) Affected / at Risk (%)
Total   687/867 (79.24%)   698/874 (79.86%) 
Eye disorders     
Cataract  51/867 (5.88%)  44/874 (5.03%) 
Gastrointestinal disorders     
Constipation  107/867 (12.34%)  121/874 (13.84%) 
Diarrhoea  50/867 (5.77%)  65/874 (7.44%) 
Gastrooesophageal reflux disease  53/867 (6.11%)  39/874 (4.46%) 
Nausea  101/867 (11.65%)  99/874 (11.33%) 
Pain  122/867 (14.07%)  121/874 (13.84%) 
General disorders     
Fatigue  47/867 (5.42%)  48/874 (5.49%) 
Oedema  139/867 (16.03%)  154/874 (17.62%) 
Infections and infestations     
Sinusitis  46/867 (5.31%)  55/874 (6.29%) 
Upper respiratory tract infection  63/867 (7.27%)  66/874 (7.55%) 
Urinary tract infection  109/867 (12.57%)  85/874 (9.73%) 
Injury, poisoning and procedural complications     
Fall  97/867 (11.19%)  91/874 (10.41%) 
Investigations     
Weight decreased  50/867 (5.77%)  35/874 (4.00%) 
Weight increased  101/867 (11.65%)  137/874 (15.68%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  64/867 (7.38%)  81/874 (9.27%) 
Back pain  106/867 (12.23%)  105/874 (12.01%) 
Muscle spasms  53/867 (6.11%)  101/874 (11.56%) 
Musculoskeletal pain  45/867 (5.19%)  43/874 (4.92%) 
Pain in extremity  31/867 (3.58%)  47/874 (5.38%) 
Nervous system disorders     
Dizziness  81/867 (9.34%)  62/874 (7.09%) 
Somnolence  67/867 (7.73%)  61/874 (6.98%) 
Psychiatric disorders     
Anxiety  77/867 (8.88%)  65/874 (7.44%) 
Depression  106/867 (12.23%)  100/874 (11.44%) 
Hallucination  39/867 (4.50%)  45/874 (5.15%) 
Insomnia  101/867 (11.65%)  96/874 (10.98%) 
Renal and urinary disorders     
Pollakiuria  50/867 (5.77%)  34/874 (3.89%) 
Proteinuria  49/867 (5.65%)  47/874 (5.38%) 
Vascular disorders     
Hypertension  46/867 (5.31%)  46/874 (5.26%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karl Kieburtz, Director of CTSI
Organization: University of Rochester
Phone: 585-275-0553
EMail: Karl.kieburtz@chet.rochester.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karl Kieburtz, University of Rochester
ClinicalTrials.gov Identifier: NCT00449865    
Other Study ID Numbers: U01NS43128 NET-PD
CRC
First Submitted: March 20, 2007
First Posted: March 21, 2007
Results First Submitted: February 19, 2015
Results First Posted: April 2, 2015
Last Update Posted: April 2, 2015